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रजिस्ट्री सं. डी.एल. (एन) 04/0007/2003—05

REGD. NO. D. L. (N) 04/0007/2003—05

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सी.जी.-डी.एल.-सा.-12092020-221707

CG-DL-W-12092020-221707

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प्राधिकार से प्रकाशित

PUBLISHED BY AUTHORITY

साप्ताहिक

WEEKLY

सं. 30] नई दिल्ली, अगस्त 16—अगस्त 22, 2020, शनिवार/ श्रावण 25—श्रावण 31, 1942 No. 30] NEW DELHI, AUGUST 16—AUGUST 22, 2020, SATURDAY/SRAVANA 25— SRAVANA 31, 1942 इस भाग में भिन्न पृष्ठ संख्या दी जाती है जिससे कि यह पृथक संकलन के रूप में रखा जा सके Separate Paging is given to this Part in order that it may be filed as a separate compilation

भाग II—खण्ड 3—उप-खण्ड (ii)

PART II—Section 3—Sub-section (ii)

भारत सरकार के मंत्रालयों (रक्षा मंत्रालय को छोड़कर) द्वारा जारी किए गए सांविधिक आदेश और अधिसूचनाएं Statutory Orders and Notifications Issued by the Ministries of the Government of India (Other than the Ministry of Defence)

विदेश मंत्रालय

(सी.पी.वी. प्रभाग)

नई दिल्ली, 29 जुलाई, 2020

का.आ. 676.-—राजनयिक और कोंसुलीय अधिकारी (शपथ एवं फीस) के अधिनियम, 1948 की धारा 2 के खंड (क) के अनुसरण में वैधानिक आदेश ।

एतद्द्वारा, कें द्र सरकार भारत के प्रधान कोंसलावास, हैमवर्ग में श्री मनीष, सहायक अनुभाग अधिकारी को दिनांक 29 जुलाई 2020 से सहायक कोंसुलर अधिकारी के तौर पर कोंसुलर सेवाओं के निर्वहन के लिए प्राधिकृ त करती है।

[फा. सं. टी-4330/01/2016]

विष्णु कु मार शर्मा, निदेशक (सी.पी.वी.)

3625 GI/20

(1905)

MINISTRY OF EXTERNAL AFFAIRS

(CPV DIVISION)

New Delhi, the 29th July, 2020

S.O. 676 .—Statutory Order in pursuance of the clause (a) of the Section 2 of the Diplomatic and Consular Officers (Oaths and fees) Act, 1948 (41 of 1948), the Central Government hereby appoints Shri Manish, Assistant Section Officer as Assistant Consular Officer in Consulate General of India, Hamburg to perform the Consular services with effect from 29 July, 2020.

[F. No. T-4330/01/2016]

VISHNU KUMAR SHARMA, Director (CPV)

कार्मिक, लोक शिकायत तथा पेंशन मंत्रालय

(कार्मिक और प्रशिक्षण विभाग)

नई दिल्ली, 19 अगस्त, 2020

का.आ. 677.—के न्द्र सरकार, एतदद्वारा दिल्ली विशेष पुलिस स्थापना अधिनियम, 1946 (1946 की अधिनियम संख्या 25) की धारा 5की उप-धारा (1) सपठित धारा 6 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए आंध्र प्रदेश राज्य सरकार, गृह (एससी.ए) विभाग अधिसूचना जी.ओ. एमएस सं. 111, दिनांक 12.09.2019 सपठित इसकी संशोधित अधिसूचना जी.ओ. एमएस सं. 172, गृह (एससी.ए) विभाग, दिनांक 24.12.2019 सपठित इसकी शुद्धि पत्र, जिसे जी.ओ. एमएस सं. 13, गृह (एससी.ए) विभाग, दिनांक 20.01.2020 के माध्यम से जारी किया गया और सपठित इसकी संशोधित अधिसूचना जी.ओ. एमएस सं. 72, गृह (एससी.ए) विभाग, दिनांक 25.06.2020, के माध्यम से जारी सहमति से पिदुगुरल्ला मंडल के कोणांकी गांव, के सानुपल्ली और दाचेपल्ली मंडल के नादीकु दी गांव, गु ंटुर जिला में चूना पत्थर के अवैध खनन/खदान क्रिया और अवैध परिवहन के संबंध में निम्नलिखित सारणी में उल्लिखित मामलों में किए गए अपराध(धों) के अन्वेषण करने के लिए तथा ऐसे अपराध(धों) से जुड़े या उससे संबद्ध किसी दुष्प्रयास, दुष्प्रेरणा और षड्यंत्र एवं/अथवा उसी संव्यवहार में किए गए या उन्हीं तथ्यों से उत्पन्न किसी अन्य अपराध(धों) का अन्वेषण करने के लिए दिल्ली विशेष पुलिस स्थापना के सदस्यों की शक्तियों और क्षेत्राधिकार का विस्तार समस्त आंध्र प्रदेश राज्य में करती हैः-

[फा. सं. 228/31/2019-एवीडी-II]

एस. पी. आर. त्रिपाठी, अवर सचिव

MINISTRY OF PERSONNEL, PUBLIC GRIEVANCES AND PENSIONS

(Department of Personnel and Training)

New Delhi, the 19th August, 2020

S.O. 677 .—In exercise of the powers conferred by sub section (1) of Section 5 read with Section 6 of the Delhi Special Police Establishment Act, 1946 (Act No. 25 of 1946), the Central Government with the consent of the State Government of Andhra Pradesh, issued vide Home (SC.A) Department Notification G.O. Ms. No. 111, dated 12.09.2019 r/w its amendment Notification G.O. Ms. No. 172, Home (SC.A) Department, dated 24.12.2019 r/w its Corrigendum issued vide G.O. Ms. No. 13, Home (SC.A) Department, dated 20.01.2020 and r/w amendment Notification G.O. Ms. No. 72, Home (SC.A) Department, dated 25.06.2020, hereby extends the powers and jurisdiction of the members of the Delhi Special Police Establishment to the whole State of Andhra Pradesh for investigation into the offence(s) relating to illegal mining/quarrying and illegal transportation of Limestone in Konanki Village of Piduguralla Mandal, Kesanupalli and Nadikudi Villages of Dachepalli Mandal, Guntur District in the cases mentioned in the following table and any attempt, abetment and conspiracy in relation to or in connection with such offence(s) and/or for any other offence committed in the course of the same transaction or arising out of the same facts:-

[F. No. 228/31/2019-AVD-II]

S. P. R. TRIPATHI, Under Secy.

कृ षि एवं किसान कल्याण मंत्रालय

(कृ षि, सहकारिता एवं किसान कल्याण विभाग)

(राजभाषा प्रभाग)

नई दिल्ली, 20 जुलाई, 2020

का.आ. 678 .—कें द्रीय सरकार, राजभाषा (संघ के शासकीय प्रयोजनों के लिए प्रयोग) नियम, 1976 के नियम 10 के उप नियम (4) के अनुसरण में कृ षि, सहकारिता एवं किसान कल्याण विभाग, कृ षि एवं किसान कल्याण मंत्रालय के प्रशासनिक नियंत्रणाधीन निम्नलिखित संस्थान को जिसके 80 प्रतिशत कर्मचारियों ने हिंदी का कार्यसाधक ज्ञान प्राप्त कर लिया है, अधिसूचित करती है: -

चौ. चरण सिंह राष्ट्रीय कृ षि विपणन संस्थान,

कोटा रोड, बम्बाला, प्रताप नगर,

जयपुर – 302033, राजस्थान

[फा. सं. 3-3/2011-रा.भा.नी.]

अश्वनी कु मार, संयुक्त सचिव1910 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)]

MINISTRY OF AGRICULTURE AND FARMERS WELFARE

(Department of Agriculture, Cooperation and Farmers Welfare)

(OFFICIAL LANGUAGE DIVISION)

New Delhi, the 20th July, 2020

S.O. 678 .—In pursuance of Sub Rule (4) of the Rule 10 of the Official Languages (Use for Official Purposes of the Union) Rules, 1976 the Central Government herby notifies the following Institute which is under the administrative control of the Department of Agriculture, Cooperation and Farmers Welfare, Ministry of Agriculture and Farmers Welfare whereof 80% staff have acquired the working knowledge of Hindi-

CCS National Institute Of Agricultural Marketing,

Kota Road, Bambala, Pratap Nagar,

Jaipur, Rajasthan-302033

[F. No. 3-3/2011-Official Language Policy]

ASHWANI KUMAR, Jt. Secy.

नई दिल्ली, 20 जुलाई, 2020

का.आ. 679 .—कें द्रीय सरकार, राजभाषा (संघ के शासकीय प्रयोजनों के लिए प्रयोग) नियम, 1976 के नियम 10 के उप नियम (4) के अनुसरण में कृ षि, सहकारिता एवं किसान कल्याण विभाग, कृ षि एवं किसान कल्याण मंत्रालय के संबद्ध कार्यालय वनस्पति संरक्षण, संगरोध एवं संग्रह निदेशालय, फरीदाबाद के अंतर्गत निम्नलिखित प्रशासनिक नियंत्रणाधीन कार्यालयों को जिनके 80 प्रतिशत कर्मचारीवृन्द ने हिंदी का कार्यसाधक ज्ञान प्राप्त कर लिया है, अधिसूचित करती है: -

1. कें द्रीय एकीकृ त नाशीजीव प्रबंधन कें द्र, प्लॉट नं.- 2. टिड्डी मंडल कार्यालय,

195/663, पाईका नगर, पी.ओ. बरमु ंडा कॉलोनी, एनएच-15, आईटीआई,

भुवनेश्वर -751003 (ओडिशा)

रेलवे क्रांसिंग के पास, फलौदी,

जिला - जोधपुर-342301 (राजस्थान)

3. कें द्रीय एकीकृ त नाशीजीव प्रबंधन कें द्र, लक्ष्मी निवास, 4. टिड्डी मंडल कार्यालय,

कृ षि भवन, कांके रोड, रांची - 834008 (झारखंड)

कलेक्ट्रेट कार्यालय के नजदीक,

चुरू - 331001 (राजस्थान)

5. कें द्रीय एकीकृ त नाशीजीव प्रबंधन कें द्र, मकान नं. 6. टिड्डी मंडल कार्यालय,

82/05, एच.पी.एस., साई भवन, अरावली मार्ग, न्यू राजपूत समाजवाड़ी के पास, रावलवाड़ी रिलोके शन सांगानेर रोड, मानसरोवर, जयपुर -302020

साईट, रघुवंशी नगर, जिला भुज (कच्छ)-370,001 (राजस्थान)

गुजरात

7. टिड्डी मंडल कार्यालय, बसनी रोड, नागौर - 341001 8. टिड्डी मंडल कार्यालय, एन.एच.-62, आकाशवाणी (राजस्थान)

के पास,

बीकानेर रोड, सूरतगढ़ - 335804 (राजस्थान) 9. वनस्पति संगरोध कें द्र,

10. वनस्पति संगरोध कें द्र,

पी.ओ. दुआलजोत,

सेक्टर-ई, जानकीपुरम रिंग रोड,

इंजीनियरिंग कॉलेज क्रासिंग के

वाया-नक्सलबाड़ी पानीटंकी,

पास, लखनऊ -226021 उत्तर प्रदेश

दार्जिलिंग -734429 (पश्चिम बंगाल)

[फा. सं. 3-3/2011-रा.भा.नी.]

अश्वनी कु मार, संयुक्त सचिव[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1911

New Delhi, the 20th July, 2020

S.O. 679 .—In pursuance of Sub Rule (4) of the Rule 10 of the Official Language (Use for Official Purposes of the Union) Rules, 1976 the Central Government herby notifies the following offices which are under the administrative control of the Directorate of Plant Protection, Quarantine & Storage. Faridabad an attached office of the Department of the Agriculture, Cooperation & farmers Welfare, Ministry of Agriculture & Farmers Welfare whereof 80% staff have acquired the working knowledge of Hindi:—

1. Central Integrated Pest Management Centre, 2. Locust Circle Office

N.H.15, Near I.T.I Railway Crossing, Phalodi, District - Jodhpur- 342301 (Rajasthan)

Plot No. 195/663, Paika Nagar, P.O. Burmmunda Colony, Bhubaneswar (Odisha) -751 003,

4. Locust Circle Office,

Near Collectorate Office, Churu -331001 (Rajasthan)

3. Central Integrated Pest Management Centre, Laxmi Niwas, Krishi Bhawan, Kanke Road, Ranchi (Jharkhand)-834008

5. Central Integrated Pest Management Centre,

6. Locust Circle Office,

Near Rajput Samajwari, Rawalwari Relocation Sight, Raghuvanshi Nagar, District Bhuj (Kutch), Gujarat – 370001 House No. 82/05, HPS, Sai Bhawan, Arawali Marg, New Sanganer Road, Mansarover, Jaipur (Rajasthan) -302020,

7. Locust Circle Office,

8. Locust Circle Office,

Basni Road, Nagaur -341001 (Rajasthan)

N.H.- 62, Near Akashwani, Bikaner Road Suratgarh - 335804 (Rajasthan)

9. Plant Quarantine Station,

10. Plant Quarantine Station, Sector E, Jankipuram, Ring Road,

NH-31-C, P.O. DulalJote, Via- Naxalbari,

Panitanki, Darjeeling-734 429 (W.B)

Near Engeneering College Crossing Lucknow, Uttar Pradesh-226021

[F. No. 3-3/2011-Official Language Policy]

ASHWANI KUMAR, Jt. Secy.

नई दिल्ली, 20 जुलाई, 2020

का.आ. 680 .—कें द्रीय सरकार, राजभाषा (संघ के शासकीय प्रयोजनों के लिए प्रयोग) नियम, 1976 के

नियम 10 के उप नियम (4) के अनुसरण में कृ षि एवं किसान कल्याण मंत्रालय, कृ षि, सहकारिता एवं किसान

कल्याण विभाग के स्वायत्त संगठन राष्ट्रीय सहकारी प्रशिक्षण परिषद, हौज खास, नई दिल्ली के प्रशासनिक

नियंत्रणाधीन निम्नलिखित कार्यालयों को, जिनके 80 प्रतिशत कर्मचारियों ने हिंदी का कार्यसाधक ज्ञान प्राप्त कर

लिया है, अधिसूचित करती है: -

1. सहकारी प्रबंध संस्थान,

सहकारी कॉम्पलैक्स, लाम्फे लपेट,

इम्फाल (मणिपुर)- 795004

2. क्षेत्रीय सहकारी प्रबंध संस्थान,

67, पद्मनाभनगर, बनशंकरी, II स्टेज,

बेंगलुरू – 560070

[फा. सं. 3-3/2011-रा.भा.नी.]

अश्वनी कु मार, संयुक्त सचिव1912 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)]

New Delhi, the 20th July, 2020

S.O. 680 .—In pursuance of Sub Rule (4) of the Rule 10 of the Official Languages (Use for Official Purposes of the Union) Rules, 1976 the Central Government herby notifies the following offices which are under the administrative control of the National Council For Cooperative Training an Autonomous organization of the Department of Agriculture, Cooperation & Farmers Welfare, Ministry of Agriculture & Farmers Welfare whereof 80% staff have acquired the working knowledge of Hindi.

1. Institute of Cooperative Management,

Cooperative Complex,

Lamphelpat, Imphal-795004

2. Regional Institute of Cooperative Management,

67 Padmanabhanagar, Banshankari,

2nd stage, Bengaluru-560070

[F. No. 3-3/2011-Official Language Policy]

ASHWANI KUMAR, Jt. Secy.

नई दिल्ली, 14 अगस्त, 2020

—मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 की उप-धारा (1) उपबंध करती है कि केन्द्रीय सरकार सामान्यतः उक्त अधिनियम के उपबंधों को कार्यान्वित करने हेतु, उक्त अधिनियम और उसकेे अधीन बनाए गए नियमों से संगत मार्गदर्शन बना सकेगी;

और उक्त धारा की उप-धारा(2), अन्य बातों के साथ-साथ, केन्द्रीय सरकार को रक्तदाता चयन और रक्तदाता रेफरल मार्गदर्शन, 2018 बनाने के लिए सशक्त करती है;

अतः, अब, केन्द्रीय सरकार मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए इस अधिसूचना से उपाबद्ध अनुसूची के अनुसार "रक्तदाता चयन और रक्तदाता रेफरल मार्गदर्शन, 2018" अधिसूचित करती है।

[फा. सं. टी-11020/50/1999-नाको (पी एंड सी)]

आलोक सक्सेना, संयुक्त सचिव

MINISTRY OF HEALTH AND FAMILY WELFARE

New Delhi, the 14th August, 2020

S.O. 681.—Whereas sub-section (1) of section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017) provides that the Central Government may make guidelines consistent with the said Act and any rules made there under, generally to carry out the provisions of the said Act;

And whereas, sub-section (2) of the said section, inter alia, empowers the Central Government to make the Blood Donor Selection and Blood Donor Referral Guidelines, 2018;

Now, therefore, in exercise of the powers conferred by section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017), the Central Government hereby notifies the "Blood Donor Selection and Blood Donor Referral Guidelines, 2018 as per the Schedule annexed to this notification.

[F. No. T-11020/50/1999-NACO(P&C)]

ALOK SAXENA, Jt. Secy.

SCHEDULE

Blood Donor Selection

and

Blood Donor Referral Guidelines, 2018

National Blood Transfusion Council

National AIDS Control Organisation

Ministry of Health and Family Welfare

Government of India

New Delhi

1. Introduction.—The primary responsibility of a Blood Transfusion Service is to provide a safe, sufficient and timely supply of blood and blood components. In fulfilling this responsibility, the Blood Transfusion Service should ensure that the act of blood donation is safe and causes no harm to the donor. It should build and maintain a pool of safe, voluntary non-remunerated blood donors and take all necessary steps to ensure that the products derived from donated blood are efficacious for the recipient, with a minimal risk of any infection that could be transmitted through transfusion.

2. Objectives.—The donor selection criteria recommended in these guidelines apply to donors of whole blood, red cells, platelets, plasma and other blood components, donated as whole blood or through apheresis, including plasma for fractionation.

Whilst these guidelines are designed to promote best practise in Blood Transfusion Services to ensure the collection of donations from the lowest risk donors possible.

3. Donor Recruitment and Retention.—

(i) Blood should be accepted only from voluntary, non-remunerated, low risk, safe and healthy donors.

(ii) Efforts should be directed towards encouraging and retaining adequate numbers of repeat donors.

(iii) Donors should be appropriately recognised and thanked for their contribution.

(iv) The blood bank should educate donors prior to collection of blood regarding the risk of blood donation and transfusion transmissible infections.

4. Donor Selection.—(1)The steps for donor selection include-

(a) Pre-donation information,

(b) Pre-donation counselling,

(c) Donor Questionnaire and Health check-up,

(d) Counselling during blood donation,

(e) Post-donation counselling.

(2) Counselling of blood donors is to be provided by trained blood donor counsellors maintaining privacy and confidentiality. All blood banks may also train their donor organisers or medical officers to undertake counselling, in case a dedicated manpower is not available. A medical officer with minimum MBBS qualification should be responsible for reviewing the donor's health conditions and performing physical examination of the donor. The final call on donor selection is to be taken by the medical officer.

5.   Pre-donation Information(1) It should include,—
      (i)     Nature  and  use  of  blood  and  its  components  and  the  importance  of  maintaining  healthy
              lifestyles,
      (ii)    Eligibility for blood donation,
     (iii)    Rationale for the donor questionnaire and pre-donation health assessment,

       (iv)     Options for the donor to withdraw or self-defer at any time before, during or after donation,
        (v)     Blood donation process and potential adverse donor reactions,
       (vi)     Common Transfusion Transmitted Infection,  modes of transmission and window period,
      (vii)     Basic information on tests performed on donated blood,
      (viii)    Possible  consequences  for  donors  and  donated  blood  in  the  case  of  abnormal  Transfusion
                Transmitted Infection test results.
       (2)      It  can  be  done  as  a  one-on-group  and  integrated  with  the  activities  undertaken  for  donor
                recruitment and retention.
  6.   Pre-donation Counselling.-(1) It should focus on the donor and preferably be done one-on-one.
       (2)      The objectives include:
        (i)     Understanding of Donor Questionnaire to enable correct responses,
        (ii)    Reiterate  understanding  of  Transfusion  Transmitted  Infection  testing  and  the  disclosure  of
                results,
       (iii)    Clarify any misunderstanding about donor selection, blood donation and blood screening,
       (iv)     Explain self-deferral,
        (v)     Explain temporary and permanent deferral,
       (vi)     Familiarise donor to process of blood donation,
      (vii)     Obtain donor's Informed consent.
7.      Donor  Questionnaire  and  Health  Check-up.(1)  The  donor  questionnaire  and  health  check-up  is
        administered  to  every  prospective  donor  to  enable  a  quick  history  taking,  limited  physical
        examination and blood test. A questionnaire shall be prepared in English and Local languages which
        is  simple  and  easy  to  understand  to  be  answered  by  the  donor.  For  donors  who  are  illiterate,
        assistance should be given by counsellor or donor registration staff.
        (2)    Demographic  details  of  the  donor,  date  and  time  of  donor  selection  and  donation  shall  be
               registered. Informed consent shall be obtained in writing from the donors on the questionnaire.
        (3)    Prior  to  blood  donation,  the  consent  of  the  donor  shall  be  obtained  in  writing  with  donor's
               signature  or  thumb  impression  after  the  procedure  is  explained  and  the  donor  is  informed
               regarding testing of blood for all mandatory tests for safety of recipients. The donor shall be
               provided an opportunity to ask questions and refuse consent.
 8.     Donor Consent. Donor consent shall be taken for the following understanding that:
        (1)    Blood donation is a totally voluntary act and no inducement or remuneration has been offered.
        (2)    Donation of blood or its components is a medical procedure and that by donating voluntarily, I
               accept the risk associated with this procedure.
        (3)    My  donated  blood  and  plasma  recovered  from  my  donated  blood  may  be  sent  for  plasma
               fractionation  for  preparation  of  plasma  derived  medicines,  which  may  be  used  for  larger
               patient population and not just this blood bank.
        (4)    My  blood  will  be  tested  for  hepatitis  B,  hepatitis  C,  malaria  parasite,  HIV  or  AIDS  and
               Syphilis diseases in addition to any other screening tests required to ensure blood safety.
        (5)    I would like to be informed about any abnormal test results done on my donated blood Yes or
               No

Blood Donor Selection Criteria

9 Counselling During Donation.—The Counselling during donations must be aimed at.— (1) Ensuring that donors feel conformable during blood donation, including the venepuncture,

(2) Reducing donor anxiety and minimising the risk of any adverse donor reactions such as fainting,

(3) Giving post donation advice, including care of the venepuncture site, (4) Fostering donor trust and confidence for donor retention,

(5) Thanking the donor for his valuable contribution.

10 Post-donation interaction.—The post-donation interaction includes.—

(1) Brief instructions on self-care:

(i) Plenty of fluids,

(ii) No heavy work,

(iii) No smoking or driving immediately post donation,

(iv) Remove bandage after 6 hours,

(v) Contact details of blood bank in case of discomfort following donation, (2) Information about what to do in case of specific adverse donor reactions, (3) Message on healthy lifestyle and regular blood donation,

(4) Donor feedback,

(5) Reiteration for recalling of blood donor for abnormal test results.

Recall and Referral Mechanism for Sero-reactive Blood Donors

11. Information of test results.— (1)Donors who have consented to be contacted by the blood bank in case of an abnormal test result should be recalled to the blood bank so as to inform them about sero-reactive result of Transfusion Transmitted Infection.

(2) Donors should be provided post-donation counselling prior to referring those appropriate medical services for confirmation of diagnosis, follow up and treatment whenever necessary.

(3) Adequate efforts must be made by the Blood Bank staff to contact the initial sero-reactive blood donors for recall-referral and the process should be documented on record.

(4) Result seeking blood donors, even if non sero-reactive, should also be informed of their Transfusion Transmitted Infection status with reiterated counselling to remain negative and continue to donate blood.

(5) State AIDS Control Societies shall make available updated list of Integrated Counselling and Testing Centre along with contact details of counsellors to all licensed blood banks.

12 Duties of a Blood Bank.—(1)It is not the primary duty of the Blood Bank or Blood Transfusion Services to confirm the diagnosis of any of the Transfusion Transmitted Infection screened for.

(2) All initial sero-reactive blood units shall continue to be discarded as per standard operating protocol of blood bank and compliance to Biomedical Waste Management Rules, 2016.

(3) Consent of the Blood Donor shall be obtained for performing the screening tests and to be informed of the results thereof at the time of blood donation.

(4) Blood Bank shall repeat the test using the same technique using the pilot tube or sample from blood bag prior to labelling the donor as initial sero-reactive and recalling for referral.

(5) All initial sero-reactive donors shall be recalled, offered post donation counselling and referred to appropriate facility for further counselling, confirmation and management.

(6) Results shall not be informed over the telephone.

(7) A standard referral format for the same shall be used and Blood Bank shall maintain all records of recall and referral.

(8) Signatures of the blood donor shall be obtained on the consent form attached to the referral format so as to avoid litigation due to discordant results of screening at blood banks and confirmatory tests of reference centre.

(9) In case, the initial sero-reactive donor does not return to blood bank despite three consecutive weekly attempts, the list of HIV sero-reactive blood donors should be shared with the linked Integrated Counselling and Testing Centre under shared confidentiality under guidance from State AIDS Control Society.

13. Referral Mechanism of HIV Sero-reactive Blood Donors to Integrated

Counselling and Testing Centre.—

(1) Testing Strategy used in the Blood Banks for HIV is "Strategy I" and the test done in the blood bank is considered to be a test of triage (A0).

(2) The blood unit is subjected to one test of high sensitivity for HIV reactivity. If non reactive, the specimen shall be considered free of HIV (negative) and if reactive, the blood unit is considered as HIV positive and discarded. This1926 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] strategy is focused on ensuring recipient safety and is also used in the setting of screening of organs, tissues, sperm and other donations.

One test required (A0)

A0+ A0-

Consider Positive Consider Negative

Flow chart of Strategy I

(3) Prior consent shall be taken from the donor for both conduction of screening tests and to be informed of result of testing at the time of the donation by the blood bank along with complete contact details and telephone number.

(4) All blood donors found to be HIV sero-reactive at blood bank shall be referred to Integrated Counselling and Testing Centres for counselling and confirmation.

(5) Blood bank shall fill out the referral form as per standard format in annexure 2 and send it along with referred donor.

(6) Confidentiality shall be maintained at all levels.

14. Algorithm for Blood Donors Referred to Integrated Counselling and Testing

Centre.—(1) Donor shall be offered HIV pre-test counselling at the Integrated Counselling and Testing Centre and consent taken to perform the HIV test.

(2) Integrated Counselling and Testing Centre shall perform first test. In case first test positive, Integrated Counselling and Testing Centre shall perform remaining two tests and give a positive result after three sequential reactive tests.

(3) In case first test is negative, Integrated Counselling and Testing Centre shall report the result as Human Immunodeficiency Virus inconclusive and recall the donor for re-testing after two weeks.

(4) All blood donors found to be positive for HIV shall be counselled to permanently defer them from the donor pool, in addition to referral for Pre-ART during post-test counselling.

(5) In addition, the message for all People Living with AIDS to permanently defer themselves or spouses or partners from donating blood shall be incorporated into the information for all People Living with AIDS during post-test counselling.

15. Referral Mechanism of other Transfusion Transmitted Infection Sero-reactive

Blood Donors to Clinicians.—(1) The blood unit is subjected to one test of high sensitivity for Hepatitis B Virus, Hepatitis C Virus, Malaria and syphilis reactivity. If non-reactive, the specimen is to be considered free of infection (negative) and if reactive, the blood unit is considered as positive and discarded. This strategy is focused on ensuring recipient safety and is also used in the setting of screening of organs, tissues, sperm and other donations.

(2) Prior consent shall be taken from the donor for both conduction of screening tests and to be informed of result of testing at the time of the donation by the blood bank along with complete contact details and telephone number.

(3) All blood donors found to be sero-reactive at blood bank for HBV, HCV, Syphilis and Malaria shall be referred to clinicians in the Out Patient Department of associated hospitals or others for assessment and re-testing.

(4) Blood bank shall fill out the referral form as per standard format in Annexure 2 and send it along with referred donor.

(5) Confidentiality shall be maintained at all levels.

16. Algorithm for Blood Donors Referred to Clinicians.—(1) Donor shall be assessed by the clinician with history taking and clinical examination.

(2) Donor shall be referred to the laboratory for re-testing and confirmation of the test results.

(3) Donor shall be offered appropriate treatment by the assessing clinician or referred to a higher centre for the same.

(4) All blood donors found to be positive for HBV, HCV, Malaria and Syphilis should be counselled to defer themselves and their spouses or partners from the donor pool, in addition to appropriate management.

Annexure 1

(Name ………………………) (Name …………………………)[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1931

Annexure 2

REFERRAL SLIP FOR BLOOD DONORS (To be filled by Blood Bank Staff)

Name and address of the Referring Blood Bank: -

Date of Referral ………………………………………….Blood Bank ID No. …………………………..

Name of Donor…………………………………………………………………………………………......

Age ……… Gender ……… Phone Number ………………….Contact details…………………………..

Name and designation of the referring person ……………………………………………………………..

Date of testing

Reason for referral

(to be ticked)

Assay used

(III gen or Any other)

Counselling& testing for HIV

Testing of HBs Ag

Testing of HCV

Testing of VDRL or RPR

Testing of Malaria

Address of referral centre (ICTC or Clinician)…………………………………………………………………..

(Blood Bank seal with contact details) __________________________________________________________________________________________

(To be filled by ICTC or Laboratory and retained in record)

Name of Donor………………………………………Date of performing test………………………... PID No. or OPD Regn. No. ………………………………………………………………………......... Investigation done ……………………………………………………………………………………… Results …………………………………………………………………………………………………..

(Seal of ICTC or Laboratory with contact details) -------------------x-------------------------------x----------------------x--------------------x-----------------------x------------- (This part is to be filled by ICTC or Laboratory and returned to donor)

Name of the Donor or Department ……………………………………………………………………. Donor ID No. ……………………… PID No or OPD Regn. No. ………………………….. Date of Sample draw……………………………………... Instructions: Please come for retesting after 2 weeks on

1. Result to be collected on______________ 2. Repeat test at ICTC on ______________

(Seal of ICTC or Laboratory with contact details). (F.M. : _________________________) Sd/- Designation[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1933

नई दिल्ली, 14 अगस्त, 2020

—मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 की उप-धारा (1) उपबंध करती है कि केन्द्रीय सरकार सामान्यतः उक्त अधिनियम के उपबंधों को कार्यान्वित करने हेतु, उक्त अधिनियम और उसकेे अधीन बनाए गए नियमों से संगत मार्गदर्शन बना सकेगी;

और उक्त धारा की उप-धारा(2), अन्य बातों के साथ-साथ, केन्द्रीय सरकार को राष्ट्रीय एड्‌स नियंत्रण परियोजना के अधीन ओपिऑएड प्रतिस्थापन चिकित्सा, बूप्रेनॉरफाइन के साथ उपचारार्थ चिकित्सीय पद्धति मार्गदर्शन के प्रयोजनार्थ बनाने के लिए सशक्त करती है;

अतः, अब, केन्द्रीय सरकार मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए इस अधिसूचना से उपाबद्ध अनुसूची के अनुसार "बूप्रेनॉरफाइन के साथ उपचारार्थ चिकित्सीय पद्धति मार्गदर्शन (राष्ट्रीय एड्‌स नियंत्रण कार्यक्रम के अधीन ओपिऑयड प्रतिस्थापन चिकित्सा)", 2018 अधिसूचित करती है।

[फा. सं. टी-11020/50/1999-नाको (पी एंड सी)]

आलोक सक्सेना, संयुक्त सचिव

New Delhi, the 14th August, 2020

S.O. 682 .—Whereas sub-section (1) of section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017) provides that the Central Government may make guidelines consistent with the said Act and any rules made there under, generally to carry out the provisions of the said Act;

And whereas sub-section (2) of the said section, inter alia, empowers the Central Government to make guidelines for the purposes of Opioid Substitution Therapy Under National AIDS Control Programme, Clinical Practice Guidelines for Treatment with Buprenorphine;

Now, therefore, in exercise of the powers conferred by section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017), the Central Government hereby notifies the "Clinical Practice Guidelines for Treatment with Buprenorphine (Opioid Substitution Therapy Under National AIDS Control Programme), 2018" as per the Schedule annexed to this notification.

[F. No. T-11020/50/1999-NACO(P&C]

ALOK SAXENA, Jt. Secy.

SCHEDULE

"Clinical Practice Guidelines

for Treatment with Buprenorphine"

(Opioid Substitution Therapy Under

National AIDS Control Programme), 2018

Message

India has made significant achievements in containing Human Immunodeficiency Virus (HIV) infection.

India is one of the few countries across the globe that has been able to bring about reduction in the incidence of HIV in the country. Additionally, HIV prevalence among certain high risk groups such as female sex workers has also been reduced. This has been possible due to massive efforts from all the stakeholders concerned, including the civil society, affected communities, technical experts, as well as the various divisions working within the Department of AIDS Control (DAC).

While there is much to celebrate, certain high risk groups continue to show high prevalence of HIV.

Injecting Drug Users (IDUs) is one such group that has more than 5% HIV prevalence consistently across various rounds of sentinel surveillance. Efforts have been made in the third phase of the National AIDS Control Programme (NACP) to scale up HIV prevention services for Injecting Drug Users, mainly with respect to Needle Syringe Programmes. There are more than 280 targeted interventions (TIs) working exclusively for Injecting Drug Users, covering more than 80% of the Injecting Drug Users population in the country. Opioid Substitution Therapy (OST) is another important element of HIV prevention among Injecting Drug Users. The process of initiating Opioid Substitution Therapy within the HIV programme began during National AIDS Control Programme III, and a number of quality assurance mechanisms were built in the programme. Newer models of Opioid Substitution Therapy delivery were also tested and found to be equally feasible. There are currently about 150 Opioid Substitution Therapy centres in the country catering to about 15000 Injecting Drug Users.

Opioid Substitution Therapy remains an important intervention strategy in the National AIDS Control Programme IV, and Department of AIDS Control is committed to scale up the Opioid Substitution Therapy intervention, so that a greater number of Injecting Drug Users would benefit from this intervention strategy. The revised clinical practice guidelines document is in tune with this commitment. I am given to understand that the experience accumulated so far in Opioid Substitution Therapy implementation under National AIDS Control Programme has been made use of to modify the document. I am sure that this revised guideline from Department of AIDS Control would help the service providers to provide optimum care and treatment for the Injecting Drug Users. I wish the stakeholders all the best for their endeavours.

Secretary

Department of AIDS Control1936 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Preface The present document is a revision of the document "Substitution Therapy with Buprenorphine for Opioid Injecting Drug Users – Practice Guidelines" that was developed by the National AIDS Control Organisation in 2008 for guiding the implementation of National AIDS Control Organisation supported Opioid Substitution Therapy (OST) programmes in India. The current revision of the document has been made taking into consideration a number of developments. Opioid Substitution Therapy programme in India has progressed to a great extent through National AIDS Control Programme (NACP) since 2008. The National AIDS Control Organisation Opioid Substitution Therapy programme was in its nascent stages in 2008, with handful of centres as well as limited capacities to implement Opioid Substitution Therapy services. Today, the OST programme is functional in at least 150 centres, and National AIDS Control Organisation Opioid Substitution Therapy has more than six years of experience in supporting the training, monitoring and supervision of these centres. Apart from initial trainings conducted, a number of other activities such as refresher trainings, quality assurance visits, accreditation and supervisory visits by National AIDS Control Organisation officers have been conducted. This has led to a deeper understanding of the problems faced by the service providers in the day-to-day implementation of Opioid Substitution Therapy programme. The existing document was found inadequate to guide the service providers, especially the clinical staff working in Opioid Substitution Therapy centres, which form the backbone of the intervention implementation.

There have been a number of changes made in the document. A detailed background section is now provided that provides a conceptual understanding of the need for Opioid Substitution Therapy for injecting drug users (IDUs). The section on clinical practices has been expanded and the specific goal, objectives and practices thereof for the particular stage of the Opioid Substitution Therapy implementation has been added. Finally, the section on special clinical situation has been introduced for the first time that deals in detail with day-to-day problems encountered by clinicians in Opioid Substitution Therapy implementation. Special issues such as adolescence and pregnancy have been dealt with in greater detail.

The primary audience for the document remains the medical and paramedical staff working in the National AIDS Control Organisation-supported Opioid Substitution Therapy centres. However, the writing style has been kept simple so that even other staff can benefit from the document. It is hoped that the document helps in improving the quality of Opioid Substitution Therapy interventions in the country. The authors are thankful to the reviewers for providing feedback on the document. Special thanks also to National AIDS Control Organisation Targeted Intervention division for their encouragement and feedback on the document. Finally, thanks are also due to the various Opioid Substitution Therapy centre staff as well as the service recipients who have provided greater understanding of the Opioid Substitution Therapy programme that has made this revision possible.

Ravindra Rao

Alok Agrawal

Atul Ambekar[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1937 Table of Contents

ABBREVIATIONS

08 INTRODUCTION

09 BACKGROUND

12 Understanding Injecting Drug Use and Injecting Drug Users 13 Opioid Substitution Therapy – Basic Concepts and Principles 17

23 Buprenorphine – Basics of Pharmacology

28 CLINICAL PRACTICE GUIDELINES

32 Assessment and Diagnosis

Determining Suitability of Clients for Opioid Substitution Therapy 35

37 Preparing Clients for Opioid Substitution Therapy

38 Buprenorphine based Opioid Substitution Therapy

46 Management of Common Clinical Situations

48 Management of Special Clinical Conditions

51 CONCLUSIONS

REFERENCES

52 ANNEXURES

531938 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Abbreviations

ANM Auxiliary Nurse Midwifery

ART Anti-Retroviral Treatment

CHC Community Health Centre

DAC Department of AIDS Control

DIC Drop-in Centre

DOTS Daily Observed Treatment Strategy

HIV Human Immunodeficiency Virus

HRGs High Risk Groups

ICTC Integrated Counselling and Testing Centre

IDU Injecting Drug Use

NACP National AIDS Control Programme

NAS Neonatal Abstinence Syndrome

NDPS Narcotic Drugs and Psychotropic Substances

NGOs Non-Governmental Organisations

NSP Needle Syringe Programme

ODS Opioid Dependence Syndrome

OST Opioid Substitution Therapy

PHC Primary Health Centre

SACS State AIDS Control Society

STI Sexually Transmitted Infection

TB Tuberculosis

TI Targeted Intervention

UNAIDS Joint UN Programme on HIV or AIDS

UNODC United Nations Office on Drugs and Crime

WHO World Health Organisation[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1939 Introduction

It is estimated that there are 177000 Injecting

Drug Users in India. The distribution of Injecting

Drug Use (IDU) population is not uniform

throughout the country. As of 2014, there are

some states that have high number of Injecting

Drug Users (IDUs) including, Manipur, Nagaland,

Punjab, Mizoram and Delhi. Injecting Drug User is

an important factor in the transmission dynamics

of HIV epidemic in India. HIV in India is a

concentrated epidemic – concentrated in certain

geographical areas and among certain population

groups. These population groups, designated as

High Risk Groups (HRGs), have much higher

prevalence of HIV as compared to the general

population. As per the latest HIV sentinel

surveillance report, HIV prevalence among

Injecting Drug Users is 7.2% nationally, which is

one of the highest among any population group.

However, some states have much higher HIV rates

among Injecting Drug Users; for e.g. HIV

prevalence among Injecting Drug Users is 21% in

Punjab, 18% in Delhi and around 12% in Manipur

and Mizoram.

Thus, there is considerable variability among COMPREHENSIVE PACKAGE OF INTERVENTIONS:

1. Needle Syringe Programmes.

2. Opioid Substitution Therapy.

3. Anti-retroviral Therapy.

4. Counselling and Testing for HIV.

5. Prevention and Treatment

for Sexually Transmitted

Infections (STIs).

6. Condom programme for

Injecting Drug Users and

their partners.

7. Targeted

Information,

Education and

Communication.

8. Prevention, Diagnosis

and Treatment of

Tuberculosis.

9. Prevention, Diagnosis

and Treatment of Viral

Hepatitis.

Injecting Drug Users in terms of their numbers,

their choice of drugs for injecting, their socio-

demographic characteristics, and HIV prevalence

among the group.

A. NATIONAL STRATEGY FOR HIV PREVENTION AMONG

INJECTING DRUG USER POPULATION.—Globally, the

"harm reduction" strategy is employed to

manage HIV prevention among Injecting Drug

Users. Harm reduction strategy is based on the

premises that it is as important to focus on

addressing harms associated with drug use as it

is to help them give it up. The strategy offers an

effective alternative approach for continuous

engagement and HIV prevention among drug

users, especially those who are unable or

unwilling to give up drug use through other

abstinence-oriented approaches. Priority is accorded

to immediate, easily preventable harms of public health importance. HIV prevention becomes

an important focus of harm reduction. A number

of interventions have been found to be useful and

effective for HIV prevention among Injecting Drug

Users. World Health Organisation, Joint UN

Programme on HIV or AIDS and United Nations

Office on Drugs and Crime, together, have

proposed nine interventions for HIV prevention,

care and treatment of Injecting Drug Users which,

when implemented together, are called the

"comprehensive package of interventions" for HIV

prevention among Injecting Drug Users. The core

interventions among these include – Needle

Syringe Programme (NSP), Opioid Substitution

Therapy (OST), and Anti-Retroviral Treatment

(ART).

In India, the harm reduction strategy is endorsed

in the National AIDS Prevention and Control Policy

(NAPCP), 2002. Department of AIDS Control (DAC)

is the nodal agency responsible for HIV prevention,

care and treatment in India. Department of AIDS

Control follows a 'targeted intervention (TI)'1940 THE GAZETTE OF INDIA : JAUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] approach for HIV prevention among all High Risk Groups, including Injecting Drug Users. The targeted intervention approach entails providing interventions specifically aimed at High Risk Groups through outreach and peer-based delivery.

implementing Targeted Intervention projects, a number of documents for standardisation and quality assurance have been developed by Department of AIDS Control, including practice guidelines for buprenorphine, standard operating In the 'outreach' model, services are delivered at procedures and quality assurance manual. The places where the High Risk Groups are most likely to be found, using their own peers as primary agents of service delivery (peer-based service delivery). The Targeted Intervention projects are implemented by Non-Governmental Organisations (NGOs) who are able to reach out to High Risk Group much more efficiently as compared to the traditional service delivery systems. For HIV prevention among Injecting Drug Users, the targeted intervention-based services include – Needle Syringe Programme, condom distribution, abscess prevention and management, general medical care, Sexually Transmitted Infection prevention and treatment, and behaviour change communication. Additionally, testing for HIV, Antiretroviral Therapy, Tuberculosis diagnosis and treatment, as well as drug treatment services are provided through referral linkages to the concerned service provider.

As in 2014, there are more than 280 core Injecting Drug Users Targeted Interventions throughout the country, reaching out to about 152000 Injecting Drug Users, which is more than 80% of the Injecting Drug User population in the country. Thus, there is a saturation of the coverage of Injecting Drug Users with HIV prevention services in India. Programmatic data also shows that there has been a significant increase in commodity distribution, number of needle or syringes distributed per Injecting Drug User, referrals for HIV testing, etc.

B. OPIOID SUBSTITUTION THERAPY UNDER NATIONAL AIDS CONTROL PROGRAMME.— Opioid Substitution Therapy as a HIV prevention strategy among Injecting Drug Users was formally integrated in National AIDS Control Programme (NACP) in 2007, during its third phase. Before formal integration, Opioid Substitution Therapy for HIV prevention among Injecting Drug Users was being implemented. in India by some Non-Governmental Organisations. After a formal approval for Opioid Substitution Therapy implementation, besides putting in place mechanisms for financial support to the Non-Governmental Organisations Non-Governmental Organisation Opioid Substitution Therapy centres were also accredited through an independent accreditation agency, following which they started receiving support through Department of AIDS Control. In this Non- Governmental Organisations-based model of Opioid Substitution Therapy, the Opioid Substitution Therapy centres located within the Drop-in-Centre (DIC) of an Injecting Drug User Targeted Intervention are managed by the staff implementing the Injecting Drug User Targeted Intervention. A part-time doctor, a full-time nurse, a counsellor or Auxiliary Nurse Midwifery, programme manager and outreach workers are part of the team delivering Opioid Substitution Therapy services.

To further expand the Opioid Substitution Therapy programme, since 2010, Government hospitals have also been roped in for providing Opioid Substitution Therapy services through a collaborative public health model. In this model, the Opioid Substitution Therapy centre is located within the government hospital and is manned by a full-time staff comprising of a doctor, a nurse, a counsellor and a data manager. The staff of the Opioid Substitution Therapy centre works under the direct supervision of a designated 'nodal officer', who is a full-time employee of the hospital. The Opioid Substitution Therapy centre is linked with an Injecting Drug Users Targeted Intervention located in the vicinity of the hospital for initial referral of Injecting Drug Users clients to the centre, as well as field-based follow-up and advocacy. Currently, there are about 150 Opioid Substitution Therapy centres in the country supported by Department of AIDS Control, operating through either the Non-Governmental Organisation or the collaborative public health model, catering to about 15000 Injecting Drug Users. There is a plan to establish about 350 Opioid Substitution Therapy centres and increase the Opioid Substitution Therapy coverage to 35000–40000 Injecting Drug Users during National AIDS Control Programme IV.

About the document...

1. The clinical practice guidelines are intended to be used by the staff implementing Opioid Substitution Therapy interventions supported under the National AIDS Control Programme.

2. This edition of the Clinical Practice Guidelines supercedes the earlier edition, published in 2008.

3. While all staff members (including those of linked Injecting Drug User Targeted Interventions) would be benefitted, these guidelines are especially relevant for doctors and counsellors working in these centres. The guidelines aim to provide guidance mainly on the clinical practices related to Opioid Substitution Therapy implementation supported by Department of AIDS Control.

4. These guidelines are not a substitute to formal training programmes, which each staff is expected to undergo. The guidelines are complementary to the "standard operating procedures" for Opioid Substitution Therapy implementation approved by Department of AIDS Control.

5. For preparing the document, the authors have heavily relied upon scientific evidence-base, especially from India, other similar guidelines published for India, the training manuals and operational procedures developed for Opioid Substitution Therapy, as well as their own clinical and programmatic experience.

Background

Understanding Injecting Drug Use and Injecting Drug Users

A. DEFINITION OF 'INJECTING DRUG USER.— Different definitions have been used for identifying who is an Injecting Drug User. Some researchers opine that a person who has injected even once in his or her lifetime is an Injecting Drug User, while others define an Injecting Drug User as someone who has injected atleast once in the past 12 months. In India, for programmatic purposes, Department of AIDS Control defines an Injecting Drug User as a person 'who has used any psychoactive substance through injecting route for non-medical purpose at least once in the last three months.'This definition is based upon the recommendation of experts working in the field of Injecting Drug User in India.

B. DRUGS INJECTED BY INJECTING DRUG USERS IN INDIA.—Though theoretically, as per the definition, an Injecting Drug User may use any psychoactive substance through injecting route, research conducted thus far has shown that in India,a vast majority of the Injecting Drug Users use opioids as their primary drug of choice. These opioids include heroin (pure or the impure – 'smack' or 'brown sugar') as wel las pharmaceutical opioids such as buprenorphine, pentazocine and dextro-propoxyphene. The opioids may be injected either alone or in combination with other substances which include benzodiazepines such as diazepam, or antihistamines such as chlorpheniramine1 or promethazine. The other substances are combined with opioids to enhance the pleasure of opioids or due to some perceptions existing among Injecting Drug Users regarding their positive effects.

OPIOIDS.—Opioids are a group of psychoactive substances that are similar in action to that of opium poppy. Opium is a plant product, extracted from the plant Papaver Somniferum.

Opioids act specifically on a set of receptors in humans, named

as opioid receptors. Some of the common opioids include:

(i) Natural derivatives: Morphine, Codeine.

(ii) Semi-synthetic: Buprenorphine, Heroin.

(iii) Synthetic: Methadone, Dextropropoxyphene, Pentazocine.

The opioids used for injection in India are: Heroin ("No. 4"), "Smack" (impure heroin),

buprenorphine, dextropropoxyphene and pentazocine.

The choice of opioids for the purpose of injecting differs from one region to another. In the north-eastern region, heroin and dextropropoxyphene are the most commonly used opioids; impure heroin, known as "smack", and buprenorphine are the most commonly used opioids in metropolitan cities such as Delhi, Mumbai, Chennai and Kolkata. In states such as Karnataka, Andhra Pradesh, Chhattisgarh, etc., pentazocine is the most commonly injected opioid. In the states of Punjab and Haryana, buprenorphine is the choice of opioid injectors. Thus, the opioids injected are either heroin or its impure variety, that is manufactured and sold illegally only for the purpose of abuse, or pharmaceutical opioids (such as buprenorphine, dextropropoxyphene and pentazocine) which are also manufactured and sold in pharmacies or chemist shops due to their medicinal value.

C. SUBSTANCE USE DISORDERS.—It must be remembered that the mere presence of behaviour of 'injecting drug use' does not qualify for a diagnosis of substance use disorder. The pattern of drug use of an individual must be dysfunctional enough to warrant a medical diagnosis for which a treatment needs to be advised. Under the International Classification of Diseases – 10th revision (ICD-10), given by the World Health Organisation(WHO), two distinct diagnostic entities exist, as below:

(i) Harmful use.—A pattern of substance use, in which a user experiences physical or psychological harms by substance use, and despite such harms, continues to use the substance.

During harmful use, though the user is not dependent on the particular substance, he or she still suffers from adverse consequences related to the use of the substance and continues the substance even though he or she experiences these harms. The user may or may not be using the substance on a daily basis.

(ii) Dependence.—This is a pattern of substance use in which the substance is used on a daily or almost daily basis, and the substance use and associated behaviour takes precedence over other behaviours or activities that were important to the individual. In this pattern of substance use, a number of symptoms generally appear in the physical, psychological and social domains that form the diagnostic criteria of dependence.

DEPENDENCE SYNDROME.— For making a diagnosis of dependence syndrome for a given substance, the following criteria should be fulfilled for at least three months in a one-year period:

a) Use of substance in high amounts over a long period of time.

b) Need to increase the quantity of substance to get the same pleasure (tolerance).

c) Appearance of specific physical and or psychological symptoms upon stopping or reducing the amount or use of substance (withdrawal symptoms).

d) Intense desire to consume the substance (craving).

e) Continued use of the substance despite harm.

f) Significant socio-occupational dysfunction due to substance use.

g) Significant time spent in procuring or using or recovering from the substance in a day.

(Adapted from ICD-10 guidelines)

The withdrawal symptoms differ from one chemical class of substance to another. Thus, for example, a typical withdrawal syndrome for any alcoholic beverage (whisky, vodka, gin, beer, wine, rum, etc.) would be sleeplessness, anxiety, restlessness, tremors, palpitations, etc. On the other hand, stimulant withdrawals may produce excessive sleep, lethargy, irritability, sadness, etc. A typical feature of withdrawal syndromes is that they tend to immediately subside once the individual re-starts using the same (or similar) substance. Thus, an alcohol dependent person experiencing withdrawal would start feeling better after drinking and an opioid dependent person would feel relieved after taking the next dose of opioids.

In case of use of more than one substance simultaneously, it is not necessary for the user to be dependent on all the substances; he or she may be dependent on one substance, while he or she may have harmful use of another substance. For e.g., an individual using opioids as well as alcohol may be dependent on opioids, while he may be using alcohol in a 'harmful use' pattern.

Usually, an individual progresses from the stage of use and harmful use before going on to develop dependence on the substance in question. As stated earlier, the stages of 'harmful use' and 'dependence' are clearly morbid and are diagnostic entities. The time taken to progress from one stage to another is different for different persons and substances consumed. For example, an opioid user usually progresses rapidly within weeks from first use to dependence.

D. OPIOID DEPENDENCE SYNDROME.—Opioid dependence syndrome (ODS) is a pattern of opioid drug use in which an individual uses opioids on a daily or almost daily basis and fulfils the criteria for dependence on opioid drugs. Some features of opioid dependence syndrome are as follows:

(i) Acute withdrawals.—Opioids as a group produce typical physical withdrawal syndrome on a short termbasis, upon reducing or stopping or even delaying the intake of the usual amount of opioid drugs. These withdrawal symptoms include lacrimation (tears from the eyes), rhinorrhoea (running nose), yawning,diarrhoea, muscle cramps, sweating, muscle aches and pains, etc. Along with these symptoms, othersymptoms include anxiety, restlessness, insomnia[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1945 (not able to sleep), irritability, as well as an intense urge (craving) to consume opioids. These 'acute' withdrawal symptoms are usually self-limiting in nature, i.e., they usually rise up to a peak level and subsequently subside on their own even without any intervention or help. However, these acute withdrawal symptoms are very distressing and disabling for the client, and often a cause for the client to restart or continue his or her opioid use. In most of the cases, once opioid use has stopped, the acute withdrawal symptoms would last for about two to three weeks before subsiding, provided the user has not resumed using opioid drugs.

(ii) Protracted withdrawals.—In most clients, even after the acute withdrawals have been resolved, some symptoms may persist for a longer period of time, i.e. up to four to six months. These include: mild aches and pains, loss of interest in pleasurable activities, pre-mature ejaculation, sleep disturbances, and craving. These symptoms are also some reasons for relapse in a number of opioid users.

(iii) Relapsing nature of illness.—As is true of other substance use disorders, especially dependence syndromes, Opioid Dependence Syndromeis also characterized by repeated relapses and remissions. An individual may restart using opioids after a period of abstinence. Such relapses and remissions are a feature of Opioid Dependence Syndrome especially among those who have used them for prolonged periods (years).

(iv) High risk behaviours.—Opioid use may be associated with various behaviours associated with high risk of transmission of blood-borne viruses such as HIV. As discussed above, opioids can be used through an injecting route, and a number of Injecting Drug Users resort to sharing of needles or syringes or other injecting equipment. Injecting is a very efficient means of transmission of blood borne viruses, including HIV, hepatitis B and C, as a result of which HIV prevalence among Injecting Drug Users is very high. Additionally, individual users may also have high risk sex behaviours resulting in transmission of HIV through the sexual route to their female partners and the sex workers.

(v) Multiple harms.—An opioid dependent user may incur harms in multiple domains of life. There may be family complications in terms of broken families, family fights, domestic violence, etc.; legal complications may include involvement in illegal activities like stealing, drug peddling, petty thefts, and incarceration, etc.; social complications may include loss of reputation or social status, being a social outcast, ridicule from society, sometimes even inhuman treatment or physical torture.

E. INJECTING DRUG USERS – RISK AND VULNERABILITY.—

(i) Injecting-related risky behaviours.— Injecting Drug Users are vulnerable to sharing of needles, syringes and other injecting paraphernalia. The sharing related behaviour may be due to a number of factors, such as non-availability of needles or syringes, non-affordability of needles or syringes or due to prevalent practices in group or peer norms, etc. Apart from sharing, there may be reuse of needles or syringes. These behaviours lead to a number of complications including abscesses, blocked veins, and transmission of blood-borne viruses such as hepatitis C, B and HIV.

(ii) Sex-related risky behaviours.—Injecting Drug Users also engage in high risk sex behaviours including sex with female sex workers, sex without condoms, and sex with multiple partners. They may also sell sex in exchange for drugs or money. These behaviours put Injecting Drug Users at risk for acquiring and transmitting HIV as well as other sexually transmitted infections to not just other injecting drug users but also to the general population.

(iii) Drug-related vulnerabilities.—As mentioned above, almost all Injecting Drug Users in India use opioids as the primary drugs for injecting; studies also show that almost all IDUs are opioid dependent.. In dependence syndrome, the use of drugs and injecting does not remain a matter of choice for the user; drug use becomes a compulsion – in the absence of drug use, the user suffers from withdrawal symptoms that compel him or her to continue or restart the use of drugs. As a result, the Injecting Drug Users suffer from harms resulting from opioid dependence in addition to the above-mentioned injecting and sex-related risks. An additional vulnerability of concern among Injecting Drug Users is of 'overdose'. If a person takes a heavier dose of drugs than he is accustomed to, this may result in serious intoxication and overdose, which is a potentially fatal, medical emergency.

Opioid Substitution Therapy– Basic Concepts and Principles Various terminologies have been used to describe the clinical practice of maintaining opioid dependent drug users on opioid medicines over a long period of time. These include–oral substitution treatment, opioid substitution treatment, oral substitution–buprenorphine, medication assisted treatment, buprenorphine maintenance treatment, methadone maintenance treatment, etc. All these terminologies describe the same practice. Under the National AIDS Control Programme, the term 'Opioid Substitution Therapy' (OST) is currently in use.

Opioid Substitution Therapy is a process in which opioid-dependent injecting drug users are provided with long acting opioid agonist medications for a long period of time under medical supervision along with psychosocial interventions. Short-term treatment of opioid dependence lasting for a couple of weeks called 'detoxification' which involves management of acute withdrawals alone, is associated with very high rates of relapse. Long-term treatment is hence necessary for opioid dependence. Opioid Substitution Therapy is one such long-term treatment option.

The lives of Injecting Drug Users revolve around illicit opioid use. Most of their day is spent in procuring the drugs, using them or recovering from the effects of the drugs. Withdrawals and craving associated with opioid use compel them to consume opioids repeatedly. As the opioid drugs usually have short-term effects, the drug using population needs to inject them multiple times throughout the day. As a result, they are not able to concentrate on other aspects of their life, including their work, family and social roles or responsibilities. They are also forced to indulge in illicit activities to finance their drug use. Opioid Substitution Therapy addresses a number of such issues faced by the Injecting Drug User clients:

1. The opioid medicines used for Opioid Substitution Therapy relieve drug-related withdrawals and craving and do not lead (when used in appropriate doses) to acute intoxication(which is seen with use of illicit opioids). Thus, the client is maintained in a state which produces neither intoxication nor withdrawals, nor craving. Due to this, the client does not need to use opioids to produce relief of withdrawals or craving.

2. As compared to the illicit opioids that act quickly and for a short period of time, opioid medicines used for Opioid Substitution Therapy act slowly and for a long period of time (for at least 24 hours). As a result, the client does not have to spend time on procuring or using opioids frequently in a given day and can focus on other important activities like occupational and family responsibilities.

3. The illicit opioids used by the clients are taken by routes that are potentially harmful. Many harmful effects faced by Injecting Drug Users are due to the injecting route of administration. On the other hand, opioid medicines used for Opioid Substitution Therapy are administrated orally or sublingually, which is a much safer route. This saves the client from incurring harmful effects of opioid use.

4. As the Injecting Drug Users procure the opioids mostly through illegal channels, they are often not aware of the purity of the opioid product they inject. This is especially true for heroin and its impure form, "smack". The purity of street heroin varies across different time periods as well as across the drug suppliers. This may result in life-threatening overdose situations if the heroin is purer than usual. On the other hand, the potency and purity of opioid medicines used for Opioid Substitution Therapy is known; this helps in averting overdose situations.

5. As the street opioid drugs are costly, Injecting Drug Users often resort to illegal activities to finance their drug use. However, as the opioid medicines used for Opioid Substitution Therapy are available in government supported centres or hospitals free of cost, the client does not have to resort to illegal means. This helps in reducing legal complications faced by the clients and also reduces instances of petty crimes like thefts, etc. in the society.

6. During the illicit drug use phase, Injecting Drug Users are often branded as anti-social or criminal by the families and the society. When on Opioid Substitution Therapy, such Injecting Drug Users are seen as sufferers and 'patients'. This renewed status helps the clients to seek help for other problems as well and makes them amenable for other help that can be provided.

BENEFITS OF OPIOID SUBSTITUTION THERAPY.—The benefits accrued from Opioid Substitution Therapy range from HIV prevention to treatment of opioid dependence, and from individual level to family and society[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1947 level. The benefits of Opioid Substitution Therapy go beyond HIV prevention alone. A large body of literature is available globally that has documented the benefits and outcomes of Opioid Substitution Therapy. Substantial research has also been conducted in India on the use of Opioid Substitution Therapy in Indian settings. Evidence globally as well as locally shows that Opioid Substitution Therapy leads to improved retention and benefits detailed in the preceding section.

Opioid Substitution Therapy has been endorsed and recommended as the most effective and first-line treatment option for long-term pharmacotherapy of opioid dependence.

BENEFITS OF OPIOID SUBSTITUTION THERAPY.—

1. Reduction in injecting behaviour.

2. Improved adherence for other treatment, especially treatment for HIV, tuberculosis and viral hepatitis.

3. Reduction in opioid use.

4. Reduced overdose related deaths.

5. Reduction in criminality.

6. Reduction in domestic violence.

7. Improved child care and family ties.

8. Improved productivity.

OPIOID SUBSTITUTION THERAPY-RELATED OUTCOMES – GLOBAL EVIDENCE.—

(i) A Cochrane review conducted by Mattick et al., 2009, concluded that Opioid Substitution Therapy using methadone was more effective (in a statistically significant manner) as compared to non-pharmacological treatment in retaining patients undergoing treatment and in suppression of heroin use.

(ii) A Cochrane review conducted by Mattick et al., 2008, concluded that buprenorphine is an effective maintenance agent for heroin dependence, but not more effective than methadone.

(iii) Large prospective cohort studies conducted over 18 months found that the odds of HIV infection were 5.4 times greater among those who were not in maintenance treatment compared with those who were in treatment (Metzger et al., 1993).

(iv) A report by World Health Organisation, 2005, reviewed many studies conducted in different parts of the world and concluded that substitution treatment is a critical component of HIV prevention, and helps in reducing opioid dependency and HIV infection rates.

(v) A systematic review and cost effectiveness by Connock in 2007 reported the following:

(a) All doses of methadone or buprenorphine were more effective in retention as compared to placebo or no therapy.

(b) Opioid Substitution Therapy using methadone or buprenorphine in higher dose was more effective in reducing illicit opioid use.

(c) A meta-analysis of observational studies spanning publications of 21 years showed that patients on Opioid Substitution Therapy using methadone were four times less likely to die than those not in treatment.

(d) Opioid Substitution Therapy using methadone significantly improved HIV-related outcomes (HIV risk behaviours, number of sex partners, frequency of unprotected sex, and rates of serocon version).

(vi) A joint position statement of World Health Organisation, United Nations Office on Drugs and Crime and Joint UN Programme on HIV or AIDS, 2004 described the cost effectiveness of Opioid Substitution Therapy as: "According to several conservative estimates, every dollar invested in opioid dependence treatment programmes may yield a return of between $4 and $7 in reduced drug-related crime, criminal justice costs and theft alone. When savings related to healthcare are included, total savings can exceed costs by a ratio of 12:1".

OPIOID SUBSTITUTION THERAPY-RELATED OUTCOMES – INDIAN EVIDENCE.— As buprenorphine has been in use most commonly in India, much of the evidence in India exists for buprenorphine; some evidence exists for slow release oral morphine, and recently, for methadone.

(i) Dorabjee and Samson, 1998, describing their experience of implementing buprenorphine- based Opioid Substitution Therapy in a community setting in New Delhi reported that 33% of 447 Injecting Drug Users on buprenorphine stopped injecting, and 35% of those injecting had reduced their frequency of injecting and sharing while on treatment.

(ii) Kumar MS, 2009 reported that Opioid Substitution Therapy intervention implemented in Manipur and Nagaland covered 1200 Injecting Drug Users and was found to be acceptable to the clients, their families, the general community, religious leaders as well as militant groups.

(iii) A study by Armstrong et al., 2010, conducted on Opioid Substitution Therapy clients in Manipur and Nagaland showed that the retention rates on Opioid Substitution Therapy was about 73% at 3 months and 63% at 6 months. Statistically significant improvements were observed in relation to sharing of needles, unsafe sex, detention incidents, and quality of life measures.

(iv) A multi-site study by Dhawan et al., 2010 showed that retention rates on Opioid Substitution Therapy were about 70% at the end of 9 months. The study showed significant decrease in opioid use, high risk behaviours, addiction severity and improvement in quality of life.

(v) A study conducted across 42 centres by Rao et al., 2012, showed that Opioid Substitution Therapy was being implemented in accordance with the Department of AIDS Control prescribed guidelines; a majority of the clients reported satisfaction with their treatment.

(vi) Studies on slow-release oral morphine conducted in New Delhi have shown that slow- release oral morphine was associated with decrease in illicit opioid use, improved functioning and reduction in illegal activities (Rao et al., 2005, 2012).

(vii) A research on methadone implementation across five centres in India showed that it is feasible to implement methadone for Injecting Drug Users in India, and is associated with improved functioning and reduced opioid use (Dhawan et al., 2013).

KEY CHARACTERISTICS OF OPIOID SUBSTITUTION THERAPY

The practice of Opioid Substitution Therapy is based on a number of principles:

Opioid Substitution Therapy is primarily a medical intervention. The medical staff (doctor and nurse) plays a lead role in Opioid Substitution Therapy intervention. The doctor conducts the assessment and diagnosis, plans and initiates treatment, monitors the progress and side effects, manages co-morbidities and terminates treatment. The nursing personnel dispense the medications, and supervise the administration of Opioid Substitution Therapy medicines. Thus, the Opioid Substitution Therapy intervention is essentially a medical intervention led by the medical team and supported by the psychosocial team.

Adequate dose of medicines is one of the most crucial determinants of a good outcome. The dose of medicines used for Opioid Substitution Therapy needs to be adequate and optimum. In general, the studies have found that the higher the dose, the better the retention in treatment and ultimate outcome.

Long duration of retention in continuous treatment is essential for a good outcome. Opioid Substitution Therapy, as a medical treatment, is expected to last for a long duration, ranging from months to years. The Opioid Substitution Therapy medicines help the clients to stabilise their chaotic lifestyles associated with drug use and assists them to improve other areas of functioning, such as familial, social and occupational. As the clients settle down in their functioning and are ready, the treatment can be tapered in consultation with the clients and their family members. In many instances, the treatment needs to be continued over years to maintain the benefits accrued by the clients. Thus, there is no fixed formula for determining the optimum duration of treatment of Opioid Substitution Therapy; the key factor in determining the duration is 'attainment of treatment goals' viz., achieving a substance-free lifestyle, optimum psychosocial functioning and reintegration into the society.

Combining psychosocial interventions along with dispensing of medicines forms the complete treatment package .Opioid Substitution Therapy works best if psychosocial interventions are combined along with Opioid Substitution Therapy medicines. Psychosocial interventions help in improving retention, and minimise drop-out, assisting the clients in regaining family and social ties and in gainful employment.

Involving the clients at all the treatment stages is crucial for success. Opioid Substitution Therapy works best if clients are involved in the decision-making process of Opioid Substitution Therapy intervention. Thus, the clients need to be involved in setting treatment goals, deciding the dose of treatment, the duration of treatment and the endpoint of treatment. These decisions, if taken along with client, help in improving client retention and outcome on Opioid Substitution Therapy.

OPIOID SUBSTITUTION THERAPY MEDICINES.—

The medicines used in Opioid Substitution Therapy should have certain properties that help the clients obtain the benefits discussed above. The Opioid Substitution Therapy medicine should:

Have action similar to the illicit opioid used by the clients. This is essential to effectively suppress the craving and withdrawals associated with cessation of opioid use. This means that an Opioid Substitution Therapy medicine should also be an agonist on the opioid receptors.

Have lesser addiction potential as compared to the illicit opioid being consumed by the client. Any Opioid Substitution Therapy medicine will have some liability to result in addiction, as it is an opioid. However, its street value should be much less than the illicit opioids, i.e. users should not prefer the Opioid Substitution Therapy medicine over illicit opioids for their addiction or intoxication.

Be easy to administer i.e. the medicine should be effective on oral or sublingual administration.

Have action lasting for at least 24 hours, so that the frequency of administration should be once a day at the maximum.

Be well tolerated. The side effects should be minimal so that the clients find it acceptable to continue Opioid Substitution Therapy medicines for a long period of time.

Be cheaper, easily available, easily stored and transported, so as to provide for a large number of clients with minimal financial or logistic constraints.

In India, methadone, buprenorphine and slow release oral morphine have been used as Opioid Substitution Therapy medicine. However, the use of buprenorphine exceeds that of the other two; Opioid Substitution Therapy programme under National AIDS Control Programme currently uses buprenorphine as the Opioid Substitution Therapy medicine, and hence buprenorphine has been discussed in detail in subsequent sections. Methadone based Opioid Substitution Therapy is also being implemented as a pilot at five sites in India.

PHARMACEUTICAL COMPOUNDS COMMONLY USED AS OPIOID SUBSTITUTION THERAPY MEDICINES

(i) Methadone.—Methadone was the first and currently, the most common opioid used as an Opioid Substitution Therapy medicine globally. Methadone is a pure opioid agonist, available

for oral use either as a liquid or as a tablet.

(ii) Buprenorphine.—Buprenorphine is a partial opioid agonist available for use as a sublingual

tablet.

It is the second most commonly used Opioid Substitution Therapy medicine worldwide.

(iii) Slow Release Oral Morphine.—Morphine is a pure opioid agonist and commonly used in

cancer patients for alleviation of pain. The slow release formulation is available as a tablet.

STATUS OF OPIOID SUBSTITUTION THERAPY IN INDIA.— Opioid Substitution Therapy is currently available in 77 countries; of these, most countries use methadone as the Opioid Substitution Therapy medicine, followed by buprenorphine. In India, Opioid Substitution Therapy has been available since the early nineties, when buprenorphine started being used in some Government hospitals as well as in some NGO settings. While the Opioid Substitution Therapy was available uninterruptedly in a few Government hospitals for both Injecting Drug User as well as non-Injecting Drug User opioid dependent users, the availability in Non-1950 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Governmental Organisations was dependent upon funding from donor partners and restricted to only Injecting Drug User population (as a HIV prevention tool). The NGO Opioid Substitution Therapy centres were subsequently supported under National AIDS Control Programme, while the Government centres continued to provide Opioid Substitution Therapy for opioid dependent individuals through funding from the Ministry of Health and Family Welfare. Additionally, there are anecdotal reports of Opioid Substitution Therapy being provided through private drug treatment centres.

The large scale expansion of the Opioid Substitution Therapy programme began with the transition of existing Opioid Substitution Therapy interventions for HIV prevention by National AIDS Control Programme in 2008, after its formal incorporation in 2007. Initially, the existing NGO Opioid Substitution Therapy centres were evaluated and accredited, and those which were found eligible were provided support by Department of AIDS Control. A total of 55 such centres were provided continued support for Opioid Substitution Therapy implementation among Injecting Drug Users. To further expand the Opioid Substitution Therapy programme, existing government hospitals at district and sub-district levels were roped in, and Opioid Substitution Therapy was initiated through the collaborative public healthcare model.

Thus, currently there are two models of Opioid Substitution Therapy being implemented under National AIDS Control Programme.

NGO OPIOID SUBSTITUTION THERAPY CENTRES.—

(a) Part of Injecting Drug User Targeted Intervention set-up. Staff largely shared with the Injecting Drug User Targeted Intervention.

(b) Opioid Substitution Therapy centre located within the Drop-in Centre of the Injecting Drug User Targeted Intervention.

(c) Medical intervention delivered by a trained part-time doctor and full-time nursing. Staff.

(d) Outreach and follow-up by the outreach staff of the Injecting Drug User Targeted Intervention

COLLABORATIVE PUBLIC HEALTH OPIOID SUBSTITUTION THERAPY CENTRES.—

(a) Opioid Substitution Therapy intervention jointly between the Government hospital and nearby Injecting Drug User Targeted Intervention.

(b) Opioid Substitution Therapy centre located in Government hospital (Medical College or District Hospital or Community Health Centre or Primary Health Centre).

(c) Separate staff at Opioid Substitution Therapy centre for medical and psychosocial

intervention.

(d) Outreach and follow-up by the Injecting Drug User Targeted Intervention.

Buprenorphine–Basics of Pharmacology As described above, the opioid family consists of a number of substances that act like opium (hence called opioids as they are similar in action to opium). The opioids have an effect mainly through their actions on the opioid receptors situated in the brain and other organ systems. There are three types of opioid receptors in the human body: mu, kappa and delta; out of these, the main action is produced by action on mu receptors. The opioids are classified as agonists, partial agonists and antagonists based on the nature of action produced on opioid receptors.

Buprenorphine is a semi-synthetic opioid derived from the baine, an alkaloid of opium. As an analgesic, buprenorphine is 25—50 times more potent than morphine. Used intravenously, 0.3 mg of buprenorphine is equivalent to 10 mg of morphine.

CLASSIFICATION BASED ON THE ACTIONS ON OPIOID RECEPTORS.—

(a) Agonists: Opioid agonists bind to and activate the mu receptors, thereby exerting 100% action-producing opioid-like effects. Examples of agonists include: morphine, codeine, dextropropoxyphene, heroin and methadone.

(b) Partial agonists: Partial agonists exert less than 100% action on the mu receptors producing

gopioid-like effects, but less than opioid agonists. Example of partial agonist includes

buprenorphine.

(c) Antagonists: Antagonists bind to the mu receptors, but do not produce any actions by themselves.

However, once they are bound to the receptors, they do not allow the opioid agonists to occupy

and act on the receptors, thus blocking the opioid actions. Additionally, if the opioid agonists are

already present at the receptors, they displace the agonists, thereby producing opioid withdrawal

syndrome. Examples of antagonists include Naloxone and Naltrexone.

PHARMACOLOGY.—The pharmacological properties of buprenorphine and its clinical implications are described below.

(i) Buprenorphine is a partial agonist of mu receptors and an

antagonist of kappa receptors. With lower doses, the action of

a partial agonist is similar to that of a full agonist. As the dose

increases, the effects of both the partial agonist and the full

agonist are increased. However, beyond a certain dose-point,

further increase in buprenorphine dose does not increase the

opioid effect. This is called as 'ceiling effect'. The figure below

illustrates the point.

Fig: Ceiling effect of Buprenorphine

Clinical implication.—The chances of overdose-related respiratory depression and consequently death are minimal with higher doses of buprenorphine. This is unlike pure agonists, where higher doses can result in overdose-related deaths due to respiratory depression.

(ii) Buprenorphine has a high affinity for opioid mu receptors.— Buprenorphine binds to the opioid receptor much more tightly than other full agonists such as morphine, heroin or methadone. Thus, buprenorphine displaces morphine and other full agonists if it is administered to individuals whose opioid receptors are occupied by the full agonists. Conversely, if the opioid receptors are already occupied by buprenorphine, it is difficult for full agonists to displace buprenorphine.

Clinical implication.—Buprenorphine can displace illicit opioids from the opioid receptors; however, as buprenorphine is a partial agonist, while illicit opioids such as heroin are full agonists, there is a net decrease in the opioid actions. This results in 'precipitated' withdrawals in the individual, if a sufficient gap between the last dose of illicit opioids consumed by the patient and the first dose of buprenorphine is not maintained. Conversely, once buprenorphine occupies the receptors, it is difficult for full agonists such as heroin to displace buprenorphine from the receptors, and produce their own actions. Thus, buprenorphine creates an opioid blocking effect. However, this blocking effect is dose-dependent – higher dose of buprenorphine blocks opioid receptors more effectively than lower doses of buprenorphine.

(iii) Buprenorphine dissociates from opioid receptors slowly as compared to other opioids. Thus, buprenorphine is a long-acting opioid with terminal elimination half-life of 24 to 37 hours. Peak clinical effect occurs one to four hours after sublingual administration. The duration of the effect depends on the dose administered: a low dose of 2 mg of buprenorphine produces clinical effect for up to 12 hours while higher doses of 16 mg can produce effects lasting up to 48 hours.

Clinical implication.—At the right doses, buprenorphine can be administered at a frequency of less than once per day. It is possible for buprenorphine to be administered every alternate day and in some cases, once in three days too.

(iv) Buprenorphine undergoes extensive metabolism in the liver, and is converted into nor- buprenorphine and other products through the cytochrome P450 3A4 Enzyme. The metabolites do not have a major effect on the brain due to their poor penetration. Most of the metabolites are excreted through faeces, and some through urine.

Clinical implication.—Due to high first-pass metabolism, buprenorphine has poor oral bioavailability, less than 10% compared to that when given intravenously. Hence, buprenorphine is not clinically effective when given orally. Buprenorphine should be administered sublingually to bypass the high first-pass metabolism. The bioavailability by the sublingual route is about 50 to 60%.

As buprenorphine is metabolised through the liver, care should be taken in those individuals who have deranged liver functioning. This is true in cases of alcohol or viral hepatitis-induced hepatic insufficiency. The metabolism of buprenorphine becomes erratic in such cases, and dose titrations may be required.

As buprenorphine is poorly absorbed orally, its effect would be milder if it is accidently ingested. The ceiling effect adds to its safety in accidental ingestion.

SIDE EFFECTS AND SAFETY PROFILE.—Buprenorphine is generally well-tolerated by drug-using individuals. Serious side effects are rare. Common side effects are generally related to the therapeutic dose (please see the accompanying box). Due to partial agonist and 'ceiling effect' property, buprenorphine does not result in respiratory depression even if it is administered at higher than therapeutic doses. In this regard, buprenorphine scores over other opioid agonists used in substitution therapy such as methadone and oral morphine. However, respiratory depression can occur even at low doses, if buprenorphine is combined with other brain depressants such as alcohol or sedatives.

COMMON SIDE EFFECTS.—

(a) Constipation (can be due to higher dose).

(b) Sedation (can be due to higher dose).

(c) Sleep disturbances.

(d) Body aches or pains (features of withdrawals; can be due to lower dose).

(e) Nausea or vomiting.

(f) Itching (in few cases and in the initial days).

(g) Dizziness.

(h) Headache.

(i) Sweating.

Buprenorphine has no major effect on hepatic functioning. Buprenorphine does not have any major effect

on psychomotor functioning as compared to opioid agonists. Thus, individuals can continue to engage in

potentially hazardous work such as driving or operating machinery. Precautions need to be taken mainly

during the initial few days during dose induction or during increase in doses.

DRUG INTERACTIONS.—Drug interactions with buprenorphine can occur due to the action of buprenorphine

on opioid receptors or due to the metabolism of buprenorphine.

(i) Sedatives.—The brain depressant effect of buprenorphine is additive to concomitant use of sedatives. These sedatives include–benzodiazepines, barbiturates and alcohol. While buprenorphine by itself does not cause respiratory depression, respiratory depression can occur even with lower doses of buprenorphine if high doses of sedatives and alcohol are concomitantly used with buprenorphine. This is particularly a concern among those drug users who have decreased respiratory reserves due to co-morbid conditions such as chronic obstructive pulmonary disease (COPD), pneumonia, etc.

(ii) Opioid agonists.—Buprenorphine prevents other opioid agonists from exerting their effect due to strong affinity to opioid receptors; conversely, buprenorphine displaces opioid agonists resulting in precipitated withdrawals, as described above.

(iii) Hepatic enzyme inducers or inhibitors.—As mentioned above, buprenorphine is metabolised in the liver through the cytochrome p450 3A4 enzymes. As a result, medications that induce cytochrome p450 3A4 enzymes can lower the blood levels of buprenorphine, thereby requiring an increase in the dose of buprenorphine. Conversely, medications that inhibit cytochrome p450 3A4 enzymes can increase the blood levels of buprenorphine, thereby requiring a decrease in the dose of buprenorphine. In both scenarios, clinicians need to monitor for the emergence of opioid withdrawal or intoxicating symptoms and decide on dose titration accordingly.

COMMON MEDICATIONS INDUCING CYTOCHROME P450 3A4 ENZYMES.—

(Buprenorphine dose may have to be increased)

(a) Anti-epileptics.—Carbamazepine,Phenobarbital, Phenytoin

(b) Anti-tubercular drugs.—Rifampicin

(c) Anti-retrovirals.—Efavirenz, Nevirapine COMMON MEDICATIONS THAT INHIBIT CYTOCHROME P450 3A4 ENZYMES:

(Buprenorphine dose may have to be decreased)Anti-fungals:Flucanazole, ketoconazole.

(a) Antibiotics: Erythromycin.

(b) Anti-depressants: Fluoxetine Fluvoxamine,Paroxetine.

(c) Anti-retrovirals: Indinavir, Ritonavir,Saquinavir.

CONTRAINDICATIONS.—The only absolute contraindication for buprenorphine is known hypersensitivity to buprenorphine.

PRECAUTIONS.—In some conditions, the clinician has to assess the primary conditions and use buprenorphine cautiously depending upon the status of the primary condition. Some of these conditions include:

(i) Respiratory conditions: Asthma, chronic obstructive pulmonary disease, kyphoscoliosis, etc.. (ii) Hepatic conditions: Alcoholic liver diseases, viral hepatitis B and C.

(iii) Abdominal conditions: Irritable bowel syndrome and other colonic conditions.

(iv) Urological conditions: Conditions causing urinary retention.

(v) Pheochromocytoma.

(vi) Hypothyroidism.

However, it should be noted that mere presence of the conditions mentioned above should not preclude use of buprenorphine in an opioid dependent individual.

ABUSE LIABILITY.—As buprenorphine is an opioid mu receptor agonist (though partial agonist), it is liable to be abused. In individuals who are not dependent on opioids, buprenorphine use through sublingual route produces euphoria and other opioid-like effects, thus increasing the likelihood that buprenorphine tablets can also be abused. Among drug users, buprenorphine is often the preferred opioid used for injecting in India. As sublingual buprenorphine is easily dissolvable in water, it can be diverted for injection purposes.

Thus, one should exercise caution in dispensing of buprenorphine to opioid dependent individuals, and hence in the National AIDS Control Programme, buprenorphine is almost always dispensed as Directly Observed Treatment (described later). However, it must be remembered that abuse liability of buprenorphine is significantly lower as compared to full agonists like heroin, morphine and methadone.

FORMULATIONS AND LEGAL STATUS IN INDIA.—Currently, in India, buprenorphine is available both in injectable and sublingual tablet form. The injectable form is commonly available as 2 ml ampoules with each ml containing 0.3 mg of buprenorphine. The injectable form is used as an analgesic. The sublingual tablets of buprenorphine are currently available in three strengths – 0.2 mg, 0.4 mg, and 2 mg.

Buprenorphine is classified as a 'psychotropic' under the Narcotic Drugs and Psychotropic Substances Act. Under the Narcotic Drugs and Psychotropic Substances Act., narcotics and psychotropics can be used for medical and scientific purposes. However, these medications should be prescribed by a doctor, and can be made available only in Government-recognised centres. The injectable form and the 0.2 mg tablet is available in pharmacies, where these formulations can be sold upon availability of a valid prescription for the same. However, the higher strengths of buprenorphine, i.e. 0.4 mg and 2 mg have been approved only for the purpose of treatment of opioid-dependent individuals and can be made available only in Government-recognised drug treatment or de-addiction centres. Both these strengths are available for use in the Opioid Substitution Therapy Programme supported by National AIDS Control Programme.

Clinical Practice

Guidelines

for Opioid Substitution Therapy Centres under National AIDS Control Programme1956 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Clinical Practice Guidelines for Opioid Substitution Therapy

Centres under National AIDS Control Programme

The Opioid Substitution Therapy intervention under National AIDS Control Programme is conceptualised as follows:

OPIOID SUBSTITUTION THERAPY INTERVENTION UNDER NATIONAL AIDS CONTROL ORGANISATION a) Opioid Substitution Therapy is a strategy for prevention of HIV among Injecting Drug Users.

b) Opioid Substitution Therapy is to be provided to Injecting Drug Users (as defined by

Department of AIDS Control) who are opioid dependent.

c) Currently, the only medicine available for Opioid Substitution Therapy is

buprenorphine.

d) Opioid Substitution Therapy is a medical intervention in which a doctor initiates Opioid

Substitution Therapy and a nurse dispenses the medicines.

e) Buprenorphine is to be dispensed on a daily basis as a 'Daily Observed Treatment' regimen.

This section would describe the clinical practices involved in Opioid Substitution Therapy implementation as guided under Department of AIDS Control. The areas covered in this section include:

(i) Assessment and diagnosis,

(ii) Determining client suitability for buprenorphine-based Opioid Substitution Therapy,

(iii) Preparing client for Opioid Substitution Therapy,

(iv) Initiating buprenorphine (induction phase),

(v) Continuation on buprenorphine (maintenance phase),

(vi) Terminating buprenorphine (termination phase),

(vii) Managing common side effects of buprenorphine,

(viii) Special clinical situations.

Psychosocial interventions provided along with Opioid Substitution Therapy are not described in this document. It is felt that the discussion on psychosocial interventions warrant a separate document altogether.

Assessment and Diagnosis

Initial assessment of the client is an essential prerequisite in Opioid Substitution Therapy intervention. The assessment helps the service provider in making appropriate decisions on the client requirement with regard to Opioid Substitution Therapy, including whether Opioid Substitution Therapy should be initiated, as well as the dosing requirements. Assessment has multiple purposes that go beyond mere Opioid Substitution Therapy consideration.

Assessment is to be carried out both by the counsellor as well as

the doctor of the Opioid Substitution Therapy centre, though the

doctor takes a larger role, since Opioid Substitution Therapy is a

medical intervention. While the counsellor would focus on the

psychosocial aspects of the client's drug use history, the doctor would

focus on the clinical or medical aspects pertaining to the client's drug

use and medical history. During assessment, the counsellor and

doctor must attempt to answer the following questions:

(i) What are the various psychoactive substances consumed by the client till date?

(ii) What is the pattern of use of various psychoactive substances consumed by the client?

(iii) Does the client fulfil the criteria for opioid dependence syndrome?

(iv) Does the client fulfil the criteria for dependence or harmful use of other substances?

(v) What is the current pattern of use of various psychoactive substances consumed by the client?

(vi) What are the various complications in the client's life or functioning due to substance use (including physical, psychological, familial, social, legal, occupational and financial areas)?

(vii) What are the high risk behaviours practiced by the client (including injecting and sex-related high risk behaviours)? What is the level of knowledge of the client regarding HIV and other consequences of high risk behaviours?

(viii) What has been the nature of previous attempts by the client to stop injecting or opioid use?

What kind of help was received by the client during these previous attempts?

(ix) What are the major facilitating factors and barriers in the recovery for the client?

(x) Does the client match the inclusion and exclusion criteria laid down in the programme for initiating Opioid Substitution Therapy?

(xi) Does the client have any medical condition that makes him or her unfit for Opioid Substitution Therapy?

(xii) What is the motivation level of the client to stop injecting and initiate Opioid Substitution Therapy?

(xiii) What is the level of psychosocial support currently available to the client for Opioid Substitution Therapy initiation and continuation?

To answer the above questions, the assessment can be conducted using various modalities covering the following areas:

ASSESSMENT MODALITIES.—

a) Interaction with the client.

b) Interaction with family members (if present during assessment).

c) Interaction with other individuals associated with the client (client's friends or peers, staff of the Injecting Drug User Targeted Intervention project, if present during assessment).

d) Review of previous treatment records, if available.

e) Observation and physical examination of the client.

ASSESSMENT AREAS.—

a) Socio-demographic details.

b) Psychoactive substance use details.

c) Complications due to substance use.

d) Injecting and other high risk behaviours.

e) Past abstinence attempts.

f) History of medical illnesses.

g) Current psychosocial support and living arrangement.

h) Current status of occupational and family functioning.

i) Evidence of current opioid withdrawals or intoxication.

j) Evidence of injection or other physical consequences of substance use (injection marks, abscesses, scars, etc.).

(Note: Specific formats exist for recording the information collected during assessment. These formats

("Intake Forms") are prescribed by Department of AIDS Control and provided by the respective State AIDS

Control Society to all the Opioid Substitution Therapy centres.)

(i) Socio-demographic details including the client's name, age, sex, marital status, educational status, occupational and employment status, and current contact information are required.

(ii) Psychoactive substance use details including chronological order of initiation of substance use, and for every substance, the age of initiation, progression, frequency of use, mode of intake of substance, any dependence features, usual dose, and last dose of intake have to be noted.

(iii) Complications due to substance use can be psychological (guilt, shame, depression, anxiety, etc.),financial (loss of money, debts, etc.), familial (fights, violence, neglect, homelessness, etc.), social (outcast, ridicule, discrimination, etc.), occupational (loss of job, irregular in work, frequent change of job, etc.), and legal (thefts, robbery, drug dealing or peddling, imprisonment, etc.).

(iv) High risk behaviours.—Both injecting (sharing, reuse of needle or syringes or other paraphernalia) and sex-related (sex with female sex workers, multiple sex partners, sex in exchange of drugs or money, sex under the influence of substances, non-use of condoms) are high risk behaviours.

(v) Abstinence attempts.—Any attempts to give up psychoactive substance use should be noted.

For every significant attempt, the duration of attempt, reason for abstinence, type of help received and reasons for relapse should be tracked. An abstinence attempt may be considered as significant if the client was able to completely stop substance use for a duration of 1 month or more.

(vi) Psychosocial support.—The nature of relationship with family members particularly spouse, the nature of relationship with non-drug-using friends, attitude of family or friends towards client's drug use, possibility of involvement in treatment process, etc.

(vii) Current living arrangement.—Type of accommodation, family members sharing accommodation, etc.

(viii) Evidence of injection.—Any needle track marks, scarring of tissue, abscesses, ulcers, etc.

(ix) Evidence of current intoxication.—Slurring of speech, altered sensorium, change in rate of speech, disinhibition, gait disturbance, etc.

(x) Evidence of current withdrawals.—Specific to the substance of use.

For opioids: Lacrimation, rhinorrhoea, yawning, dilated pupils, increased sweating, restlessness, palpitations, increased respiratory rate;

For alcohol or benzodiazepines: Anxiety, restlessness, tremors of hands, increased respiratory rate, palpitations, sweating, etc.

At the end of assessment, the doctor must be able to make a diagnosis of the client's problem and prescribe appropriate management for the same. The diagnosis should encompass the following:

1. Diagnosis of Opioid dependence.—Use of opioids in large amounts over a long period of time leading to(presence of three or more among the following in the preceding one year):

a) Tolerance.—Gradual increase in the amount of opioid intake to get the same high; appearance of withdrawals upon decreasing the dose[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1959 b) Withdrawal symptoms.— Lacrimation, rhinorrhoea, yawning, diarrhoea, cramps in abdomen, intense bodyache, insomnia

c) Craving.— Intense urge to consume opioids

d) Socio-occupational dysfunction

e) Increased time spent in obtaining opioids, consuming opioids or recovering from the effect of opioids

f) Continued use of opioids despite harms incurred due to opioid use, such as abscesses, overdose, vein loss, HIV, hepatitis B or C, respiratory problems, etc.

g) Persistent efforts to cut down opioid use.— Unsuccessful attempts or desire to give up on opioid use

2. Diagnosis of other substance use disorders.—Dependence or harmful use of other substances.

Special attention should be given to the concomitant use of alcohol and or benzodiazepines, which are general brain depressants and commonly used by opioid dependent individuals.

3. Diagnosis of medical co-morbidity, if any.—Special attention should be given to liver conditions, and respiratory conditions, which, if severe, may preclude a client from being started on Opioid Substitution Therapy.

4. Psychosocial issues that can influence treatment outcomes.—Extent of family support, presence or absence of a stable job, current involvement in illegal activities, homelessness, HIV, hepatitis B or C, etc. can influence the retention of the client on Opioid Substitution Therapy, and must be addressed during regular follow-up of the client after Opioid Substitution Therapy initiation.

Determining Suitability of Clients for Opioid Substitution Therapy

To be initiated on Opioid Substitution Therapy, the client must fulfil the suitability criteria mentioned below.

Some of these criteria are 'essential' criteria, while others are 'desirable'.

ESSENTIAL CRITERIA FOR OPIOID SUBSTITUTION THERAPY INITIATION.—The client must fulfil each of the essential criteria for Opioid Substitution Therapy initiation:

1 DIAGNOSIS OF OPIOID DEPENDENCE SYNDROME.— A diagnosis of opioid dependence syndrome is essential as Opioid Substitution Therapy is a specific medical treatment for this condition. Merely use of street opioids or injecting drug use is not sufficient to consider Opioid Substitution Therapy. Hence, before starting treatment, the doctor should carefully assess the pattern of opioid use by the client and consider Opioid Substitution Therapy only if the client meets the criteria for opioid dependence discussed above.

2 CURRENT INJECTING DRUG USERS.—The client should meet the operational criteria for Injecting Drug User established under National AIDS Control Programme i.e. he or she must have injected a psychoactive substance at least once in the past three months for non-medical purposes.

3 ABSENCE OF MEDICAL CONTRAINDICATIONS.—The client must not suffer from such medical disorders that prevent him or her from being initiated on Opioid Substitution Therapy. It must be remembered that the only absolute contraindication for Opioid Substitution Therapy with buprenorphine is known hypersensitivity to the medication. Other conditions such as respiratory, renal or hepatic insufficiency are relative contraindications and do not preclude the use of buprenorphine for Opioid Substitution Therapy. In such instances, the clinician should judge the1960 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] possible adverse effects associated with starting buprenorphine versus the benefits of treatment and decide on the course of action on a case to case basis.

4 INFORMED CONSENT.—The client must have the mental capacity to provide informed consent, as well as he should be willing to start on Opioid Substitution Therapy after understanding the implications, requirements, safeguards to be taken, etc. Under National AIDS Control Programme, a written informed consent is a must before Opioid Substitution Therapy can be prescribed to any Injecting Drug User.

5 CLIENT'S WILLINGNESS TO COME DAILY TO RECEIVE TREATMENT.—At the time of initial assessment, the client should be educated about the need to come to the Opioid Substitution Therapy centre every day to receive treatment under supervision (Daily Observed Treatment Strategy). Only those clients who agree to adhere to this mechanism should be initiated on treatment after duly signing the informed consent.

DESIRABLE CRITERIA FOR OPIOID SUBSTITUTION THERAPY INITIATION.—While the following criteria are desirable, they are not essential for a client to be initiated on Opioid Substitution Therapy. These criteria have been included as they increase the likelihood of selecting a suitable client for Opioid Substitution Therapy, thereby increasing the confidence of the clinician in prescribing the treatment.

(1) AGE MORE THAN 18 YEARS.—While it is desirable that the client should be 18 years or above to be initiated on Opioid Substitution Therapy, adolescents who are below 18 years of age can also be given Opioid Substitution Therapy. Issues to be considered in adolescents receiving Opioid Substitution Therapy is discussed in later sections.

(2) FAILED ABSTINENCE ATTEMPTS.—The client may have attempted to give up opioids in the past through other means, but has failed in doing so. This indicates greater likelihood of opioid dependence in a given client as well as lesser chances of recovery with other shorter duration treatments like detoxification.

(3) LONG DURATION OF OPIOID USE or INJECTING.—A history of long duration of opioid use (more than 3 years) indicates high severity of opioid dependence, particularly if the client has used opioids by the injecting route for most of this duration. As Opioid Substitution Therapy is considered the treatment of choice in severe opioid dependence, a client fulfilling this criterion would really require Opioid Substitution Therapy to give up drug use.

(4) MOTIVATION TO GIVE UP DRUG USE or INJECTING.—During the pre-treatment assessment, a client with better motivation is more likely to retain in treatment and accrue the benefits of Opioid Substitution Therapy. However, motivation is a dynamic phenomenon and often clients with poor motivation to abstain at Opioid Substitution Therapy initiation do well with treatment once they experience the effectiveness of Opioid Substitution Therapy in alleviating withdrawals and craving.

(5) FEASIBILITY.—It should be feasible for the client to come to the Opioid Substitution Therapy centre on a daily basis to take his Opioid Substitution Therapy dose. The feasibility here is as per the understanding of the service providers (Opioid Substitution Therapy doctor or counsellor).

However, in situations where the treating team has a different opinion about the ability of a client to come daily, the client's perception of the same should prevail and treatment should be started.

CONDITIONS REQUIRING SPECIAL CONSIDERATIONS FOR OPIOID SUBSTITUTION THERAPY INITIATION.—There are certain conditions in which caution should be exercised while prescribing Opioid Substitution Therapy to Injecting Drug Users clients. Among these, the only absolute contra-indication is known hypersensitivity to buprenorphine. In other cases, the clinician should use his or her clinical judgement before deciding on initiation of buprenorphine.

1. KNOWN HYPERSENSITIVITY TO BUPRENORPHINE.— Some clients may have had allergic reactions to buprenorphine in the past; such clients should not be given buprenorphine.

2. SEVERE DEPENDENCE ON ALCOHOL OR BENZODIAZEPINES.— If the clients have concomitant use of alcohol or benzodiazepines, and have higher degree of dependence on these substances through heavy use, Opioid Substitution Therapy may not be started in the Opioid Substitution[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1961 Therapy centre itself. Such clients should be referred to a psychiatrist or drug de-addiction centre before initiating on Opioid Substitution Therapy and may require inpatient treatment. Most Injecting Drug Users clients inject a cocktail of opioid drugs (buprenorphine or pentazocine or heroin or d- propoxyphene) along with sedatives (diazepam or pheniramine or promethazine). Such clients are seen as primarily dependent on opioids and can be safely started on Opioid Substitution Therapy.

3. SEVERE DEGREE OF HEPATIC IMPAIRMENT.—Alcohol use or infective hepatitis may result in altered metabolism of buprenorphine, leading to erratic blood buprenorphine levels. If there is clinical evidence of hepatic impairment, a liver function test may be advised and based upon the results, the decision regarding Opioid Substitution Therapy can be taken. If the derangement is mild-moderate, Opioid Substitution Therapy should be initiated, but with careful titration of dosage.

Opioid Substitution TherapyPY should be withheld only in case of sever derangement of hepatic function tests or definite clinical evidence of liver failure.

4. SEVERE DEGREE OF RESPIRATORY PROBLEMS.— In conditions such as severe asthma or chronic airway diseases leading to severe impairment of respiratory functions, Opioid Substitution Therapy should be initiated with caution, as it may further aggravate respiratory problems. Such patients should not be prescribed benzodiazepines for sleep disturbances due to their additive depressive effect on brain.

LABORATORY TESTS FOR OPIOID SUBSTITUTION THERAPY.—It is NOT ESSENTIAL to perform any

laboratory test, before initiating Opioid Substitution Therapy for a client. If the doctor has

conducted a clinical examination and has not detected any significant finding, Opioid Substitution

Therapy can be safely started. It is a good practice to conduct routine laboratory tests (such as

hemogram, liver function tests and renal function tests) in the initial days of assessment and

treatment as a 'baseline' test. In cases where there are findings present on physical examination,

the relevant laboratory tests are warranted.

Preparing Clients for Opioid Substitution Therapy

Once it is decided that the client will be initiated on Opioid Substitution Therapy, he or she should be prepared and educated before initiation. This can be done by the counsellor or the doctor. The important issues to be covered in client education:

(i) Nature of illness.—The client should be explained that opioid dependence syndrome is a chronic relapsing medical illness similar to other chronic medical illnesses such as diabetes, hypertension and other cardiovascular illnesses. It is not a weakness of will power, or a 'character defect' in the client. Relapse is part of the recovery process and there are strategies available to minimise or prevent relapse.

(ii) Nature of treatment.—The client should be informed that Opioid Substitution Therapy is a long- term treatment option; it is important for the client to remain in treatment for at least one year or more for lasting benefits. The medicines would be given as a daily observed treatment supervised by the nursing staff. The medicines would help in controlling withdrawals, and craving, and he would not need to use opioids for at least a 24-hour period after receiving the dose.

Apart from Opioid Substitution Therapy medicine, the client also needs to undergo periodic counselling as well as regular follow-up with the service providers. The client needs to follow the rules and regulations established by the Opioid Substitution Therapy centre.

(iii) Need for active involvement.—The client needs to be involved actively in the treatment process. He or she needs to be forthcoming in informing the service providers about his drug using status, benefits of treatment, sufficiency of medicine dose, and overall improvement. Additionally, if family members are involved in treatment, the outcome would be better.

Along with education, the service providers should also dispel common myths or misconceptions associated with Opioid Substitution Therapy. Additionally, this also provides the service providers an opportunity to enhance the motivation of the client towards initiation and continuation on Opioid Substitution Therapy.

Once the client has clearly understood the implications of being in Opioid Substitution Therapy programme and is ready, he or she should be asked to sign the informed consent form and Opioid Substitution Therapy should be initiated only after the consent form is signed. The consent form should have signatures of client, a witness (family member or staff) and the person who has obtained the consent (doctor or counsellor).

Buprenorphine–based Opioid Substitution Therapy

Opioid Substitution Therapy with buprenorphine can be divided into three phases:

(i) Induction phase.—Phase wherein the client is given the first dose and the dose is subsequently adjusted to achieve a stabilisation dose

(ii) Maintenance phase.—Phase wherein the client is maintained on stabilisation dose till a decision to stop buprenorphine is taken

(iii) Termination phase.—Phase from decision to stop buprenorphine to the last dose of buprenorphine

Each of these phases of Opioid Substitution Therapy treatment has different goals and objectives, management issues, and role of different service providers, etc. Each of these phases is discussed in detail below in different sections.

INITIATING OPIOID SUBSTITUTION THERAPY WITH BUPRENORPHINE – INDUCTION PHASE.—As mentioned above, the induction phase begins when the decision to initiate the client on Opioid Substitution Therapy is taken till the point where the stabilisation dose is reached.

GOALS OF INDUCTION PHASE.—

(a) To determine the correct dose of buprenorphine for a client to be able to control opioid withdrawal symptoms and craving

(b) To address any medical or psychosocial crisis faced by the client

(c) To establish rapport with the client and educate him or her about the treatment process

Before the first dose of buprenorphine, the doctor should ensure that:

(i) A detailed assessment of the client has been made, and the client fulfils the criteria for Opioid Substitution Therapy initiation as laid down by Department of AIDS Control.

(ii) The client has understood the implications and procedures of Opioid Substitution Therapy and has signed the informed consent sheet.

(iii) The last dose of opioid use is at least 6 to 8 hours before the first dose of buprenorphine.

The first dose of buprenorphine usually ranges from 2 to 4 mg. After the first dose is administered sublingually, the client should be observed after a gap of two hours, when the peak effect of buprenorphine is expected to be observed. If the client still complains of withdrawals or craving, an additional 2 to 4 mg can be given. If the client reports no symptoms of opioid withdrawal or craving, he or she should be asked to return on the next day for his dose. The total dose of buprenorphine must not exceed beyond 8 mg on day one.

On the second day, enquiry should be made regarding whether the client had any opioid withdrawal or craving symptoms anytime in the last 24 hours after the dose of buprenorphine was initiated or whether the client took any other opioid by injecting or non-injecting routes AND was able to achieve its effects. If the client reports so, the dose of buprenorphine should be increased in increments of 2 mg. The maximum dose of buprenorphine on day two should be about 12 mg. If the client does not report of any withdrawals or craving for an entire period of 24 hours following dose administration, the client would have achieved his stabilisation dose.

HOW IMPORTANT IS THE TIME GAP BETWEEN LAST DOSE OF ILLICIT OPIOID AND FIRST DOSE OF BUPRENORPHINE? This is extremely important, especially in cases where the client uses pure opioid agonist such as heroin as the illicit opioid. If the time gap is not maintained, buprenorphine would displace the illicit opioids from the receptors and precipitate opioid withdrawals symptoms, which would be extremely distressing for the client.

However, some doctors have a myth that if the client has already taken an opioid drug (like heroin) a short while ago, the first dose of buprenorphine will result in added intoxication (and risk of overdose). This is a misconception. The gap must be ensured primarily to avoid the precipitated withdrawal and not overdose.

Most clients reach their stabilisation dose in three to four days, maximum by day seven. Apart from control of craving and withdrawal, the stabilisation dose should also be able to block the euphoric effect produced by illicit opioid use. It must be remembered here that lower doses (of up to 2 to 4 mg) would be able to control withdrawal symptoms, while slightly higher doses (of up to 4 to 8 mg) would be able to take care of craving. The opioid blocking effect would be produced only at even higher doses (of 8 to 12 mg). Additionally, the higher the dose of buprenorphine, the longer is the effect of buprenorphine – i.e. a higher dose would enable the client to be without any discomfort or need for additional opioids for longer duration of at least 24 hours duration. Hence, the clinician's efforts must be to ensure that all the three objectives of Opioid Substitution Therapy dose or stopping withdrawals, control craving and produce opioid blocking effect – are achieved with the adequate dose of buprenorphine.

While guidelines from western countries recommend a maintenance dose of 12to 16 mg of buprenorphine per day, experience from India shows that for optimum outcomes, doses of 8to 12 mg of buprenorphine per day is sufficient for most clients. For maximum dose too, the guidelines from western countries suggest a maximum of 32 mg/day; however, in India, a dose of 20 to 24 mg per day can be considered as maximum dose. If the clinician feels that the client is not improving despite the maximum dose, the client

may be referred to a higher centre specialising in substance use treatment for further management.

Apart from stabilising the dose of buprenorphine, the service providers also need to work on the following

areas of the client's life during induction phase:

(i) Enhance the client's motivation to stop or reduce injecting and continue Opioid Substitution

Therapy.

(ii) Address any medical priorities. These may include conditions such as an open abscess, active

tuberculosis, or any acute co-morbid medical problem faced by the client.

(iii) Address any psychosocial crisis. This may include conditions such as recent homelessness,

impending legal crisis, etc.

DOSE INCREMENTS FOR BUPRENORPHINE.—To the extent possible, dose increments should be in round figures, preferably in multiples of 2. Thus, if a client is not comfortable on 4 mg, the next dose should be 6 mg. The fractions (using 0.2 and 0.4 mg tablets) should be limited to only those rare cases where (say) 6 mg is an inadequate dose while (say) 8 mg is perceived as a higher dose.

Additionally, the use of fractions can be considered while tapering the dose for the purpose of termination of treatment (described later).

MAINTAINING CLIENTS ON BUPRENORPHINE – MAINTENANCE PHASE.—The maintenance phase begins with the client achieving his stabilisation dose till the time a decision is made to stop Opioid Substitution Therapy for the client.

GOALS OF MAINTENANCE PHASE.—

(a) To maintain the client on adequate doses of buprenorphine

(b) To address other substance use by the client, if any

(c) To motivate and refer the client for other services, including HIV diagnosis and treatment

(d) To help the client in regaining occupational, financial and familial stability

(e) To retain the client in treatment, adhere to treatment regimen and help prevent relapse to opioid use (through injecting or other route)

(f) To help the client prevent shifting to another substance use

BUPRENORPHINE MAINTENANCE DOSE.—The clinician should continue the same dose of buprenorphine as used in the induction phase for stabilisation.

Any temptation to reduce the dose of buprenorphine must be avoided, unless specifically warranted.

Furthermore, the doctor must make enquiries on the following issues during every follow-up:

(i) Does the client have withdrawals or craving despite his current buprenorphine dose?

(ii) Has the client used any other opioids or injections while on his current buprenorphine dose?

(iii) Does the client experience euphoria while using other opioids or injections?

The information regarding the above can be elicited by interviewing the client, his family members or significant others and staff of the Targeted Intervention linked with the centre.

If the clients report that they still have (a) withdrawals or (b) craving or that (c) they use injections or other opioids and experiences euphoria on opioid use, it is an indication to the doctor that the dose of buprenorphine is inadequate. In such cases, the doctor must increase the dose of buprenorphine to an optimum level. Care must also be taken to ensure that the client does not experience opioid intoxication effect due to use of buprenorphine, such as sedation, slurring of speech, incoordination, etc. Such effects are related to the peak plasma blood levels of buprenorphine typically seen 1-3 hours after administration of the daily dose. Thus, the dose of buprenorphine must be such that the client neither has a peak effect of intoxication nor has the trough effect of withdrawal or craving. A pictorial representation of difference between the level of illicit opioids such as heroin and buprenorphine is shown below.

Once the client is maintained on a particular dose of buprenorphine which is comfortable for him or her, the SAME dose should be continued in the maintenance phase. Further changes in dose, especially dose increase, may be required in some conditions. Such conditions may include resumption of work (especially menial jobs such as manual labour, rickshaw pulling, etc.), pain conditions (such as fractures, etc.), re- emergence of craving, psychosocial distress, etc. In such cases, the doctor should re-assess the client and increase the dose as required.

An important issue during maintenance phase is to encourage and motivate clients to continue on Opioid Substitution Therapy. Many clients feel that their lives have become normal after 2 to 3 months of Opioid Substitution Therapy, as they have stopped opioid and injecting use, and feel that they can now stop Opioid Substitution Therapy. This belief is also often supported by family members, who feel that the client should now resume his or her responsibilities, sometimes at the cost of continued Opioid Substitution Therapy. The service providers must emphasise on the need for long-term continuation of Opioid Substitution Therapy medicines. The principles of motivation enhancement can be applied for encouraging the client to continue Opioid Substitution Therapy. Additionally, the family members must also be counselled on the need for continuation on Opioid Substitution Therapy.

REDUCTION OF MAINTENANCE DOSE.—It is observed that in certain cases, the doctor reduces the dose of buprenorphine despite the fact that there are no side-effects, the client is maintaining well and has not desired for dose reduction. This reduction is done as many doctors and other Opioid Substitution Therapy centre staff are under the impression that once the client has stopped using illicit opioids, his dose should be reduced to the minimum possible.

It should be important to note that the SAME DOSE OF BUPRENORPHINE AS REQUIRED IN THE INITIAL STAGES SHOULD BE CONTINUED, unless the client reports of any buprenorphine- related side effects. Even if the client requests for dose reduction, he or she should be educated on the need for the same dose. Despite this, if the client demands for dose reduction, then only the dose reduction should be attempted.

BUPRENORPHINE DISPENSING As per Department of AIDS Control guidelines, dispensing of buprenorphine is to be done on 'Daily Observed Treatment' basis at the Opioid Substitution Therapy centre. This means that the client has to come to the Opioid Substitution Therapy centre daily and take his medicines in front of the Opioid Substitution Therapy nurse. Buprenorphine is to be given through the sublingual route. The tablet should be crushed before administration to prevent diversion of the medicine by the client. The nurse should observe the client for a period of atleast 7 to 10 minutes after administering the dose to ensure that the tablets have dissolved. Detailed dispensing procedure is provided in the document on standard operating procedure.

ADDRESSING CO-MORBID SUBSTANCE USE.—Once the client is stabilised on Opioid Substitution Therapy medicines and he has stopped illicit opioid use, use of other substances may increase or resume. This is mainly because the client attempts to find other sources of pleasure and high. Most commonly, the client may reinitiate or increase consumption of other brain depressants such as alcohol, benzodiazepines or cannabis. Some clients may progress on to use of these substances in dependent pattern. Apart from problems due to the substances themselves, use of these substances also affects Opioid Substitution Therapy.—

(i) Use of these substances would increase the chance of the client relapsing to opioid use

(ii) Use of high dose of these substances would increase the risk of respiratory depression

The service providers should enquire about other substance use during maintenance phase. In case the client has re-initiated or increased his substance use, the service provider must educate the client about the risks posed, and assist the client in stopping the use of these substances. If required, the client may be referred to a psychiatrist or another specialist dealing with substance use disorder for treatment of these co-morbid conditions.

REFERRAL TO OTHER SERVICES.—Once the client is stabilised on Opioid Substitution Therapy, he or she becomes more amenable to availing other services required. The client should be motivated to undergo HIV testing and if found HIV positive, should be encouraged to register with an Anti-Retroviral Treatment centre for further management. Additionally, the client should be clinically screened for other conditions including tuberculosis, hepatitis, abscesses, etc. If the client is found to be suffering from any of these medical conditions, appropriate referral must be made. The client should also be encouraged to adhere to both Opioid Substitution Therapy as well as medications prescribed for such co-morbid conditions.

ASSISTANCE IN RE-INTEGRATION.—Maintenance phase is an excellent opportunity to motivate the client to repair ties with family, assume family responsibility and regain employment. Such re-integration with work, family and society would further help the client in maintaining abstinence from substance use and help regain the trust of his family members. Occupational rehabilitation makes the client productive once again and helps him or her to have a structured routine as well as earn a livelihood.

During follow-up, the counsellor should explore these areas and assist the client in resuming his work and ties with family. The family members should be involved in these activities, and help from them solicited if required through a home-visit.

TERMINATING CLIENTS ON BUPRENORPHINE – TERMINATION PHASE.—

The termination phase begins with taking a decision to stop buprenorphine and ends when the last dose of buprenorphine is administered to the client.

GOALS OF TERMINATION PHASE

(a) To taper and stop buprenorphine medicine

(b) To ensure that clients have minimal discomfort during tapering of buprenorphine

(c) To support the client during tapering of buprenorphine and prevent relapse during the same

(d) To help the client in making decision regarding further treatment after stopping Opioid

Substitution Therapy

(e) To motivate the client for continued follow-up after stopping Opioid Substitution Therapy

DECISION TO STOP BUPRENORPHINE.— A crucial decision in Opioid Substitution Therapy management is the decision about stopping buprenorphine treatment. There is no specified time-duration for a client to be maintained on Opioid Substitution Therapy. Opioid Substitution Therapy may last for months to years. The endpoint is reached upon the client achieving the treatment goals decided mutually by him or her and the service provider during the initiation of Opioid Substitution Therapy. The treatment goal is not limited to the client stopping his or her drug use; it also includes successful reintegration of the client in his or her family, society and work. Once these goals are reached, a decision on stopping buprenorphine can be made, if the client wishes to stop buprenorphine.

Some indicators of successful termination can include.—

(a) cessation of opioid and injecting use,

(b) cessation of illegal activities,

(c) improved ties with family,

(d) strong psychosocial support,

(e) well-maintained occupational functioning, and

(f) client's readiness to lead a medication-free life.

Despite successful outcomes, clients may still wish to continue Opioid Substitution Therapy, as they are not ready or willing to lead a medication-free life, in which case, Opioid Substitution Therapy must be continued. Continued drug use, continued perception of risk of relapse, illegal activities, poor occupational functioning, homelessness, and poor family support are the factors which indicate that Opioid Substitution Therapy should continue and should not be terminated irrespective of the duration of treatment.

TAPERING BUPRENORPHINE.—Before tapering of buprenorphine, the client must be prepared well in advance.

The family members should be involved in the decision, and support from them must be solicited. The client must be educated on the possibility of some discomfort and withdrawals during taper and relapse prevention sessions for the client must be conducted.

Buprenorphine must not be stopped abruptly, as otherwise the client would experience withdrawals and there would be the consequent risk of relapse to opioid use. The process of tapering must be gradual.

There is no fixed regime for tapering buprenorphine dose; the amount of reduction, time-gap between each reduction and the time taken for the tapering process varies from client to client. For most clients, tapering can be done on an outpatient basis in the centre itself; very few clients may require admission to a hospital for tapering of buprenorphine.

TAPERING TO A LOWER MAINTENANCE DOSE.—In clinical practice, a situation is often encountered when during the process of tapering, the dose is lowered (say, from 8 mg per day of maintenance dose to 2.4 mg per day) and any subsequent dose-reduction is met with discomfort. In such cases, clients are continued on this lower maintenance dose for many months or years.

The outpatient taper can be done over 2 to 3 months duration. In outpatient tapering, the tapering can be done in units of 2 mg of buprenorphine every 4 to 7 days, till the client reaches a dose of 2 to 4 mg of buprenorphine. Further tapering can be done in units of 0.4 to 0.8 mg of buprenorphine every 4 to 7 days.

If the client complains of withdrawals or discomfort, the tapering can be more gradual. Inpatient tapering can be faster than outpatient tapering and can be achieved in 2 to 3 weeks' time. In an inpatient setting,[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1969 the daily dose of buprenorphine can be divided into a thrice-daily regime, and 0.4 to 0.8 mg of buprenorphine can be reduced daily. Some clients experience greater discomfort as they reach the last few doses of buprenorphine, in which case the minimum dose can be continued for a longer period of time, before finally stopping buprenorphine.

MANAGEMENT AFTER TERMINATION OF BUPRENORPHINE.—Following termination of treatment, the client must be educated on the importance of continued follow-up. The follow-up can be frequent initially, once in two weeks or so, and later at a frequency of once in 1 to 3 months. During such a follow-up, enquiry must be made regarding the client's drug-using status, occupational and familial functioning, as well as re- emergence of withdrawals and craving for opioids. Relapse prevention sessions must be continued during this phase.

Post termination of buprenorphine, the client can remain free of any medication and continue follow-up at the Opioid Substitution Therapy centre. In some cases, the client can be started on antagonist maintenance. For antagonist treatment, the tablet naltrexone (at dose of 50 mg/day) should be given once a day. Before starting naltrexone, the client must be free of any opioids for at least 72-hour duration.

Unlike buprenorphine or other opioid agonists, naltrexone is not a controlled drug, and can be purchased from local pharmaceutical shops. Antagonist treatment can be continued for a period of 6 to 12months, during which the client will be fully confident of leading an opioid-free life. The medication can be stopped abruptly and does not require any tapering, unlike the agonist medicines.

If the client relapses at any stage of Opioid Substitution Therapy, he or she should be re-initiated on Opioid Substitution Therapy after assessment and diagnosis.

The principles and practices of Opioid Substitution Therapy remain the same as described earlier.

CRITICAL ISSUES IN OPIOID SUBSTITUTION THERAPY PROGRAMME

(a) Selection of appropriate clients for Opioid Substitution Therapy,

(b) Optimal dosing of buprenorphine,

(c) Proper dispensing procedures,

(d) Attitude of staff: Staff attitude plays an important part in attracting clients to the Opioid Substitution Therapy programme and ensuring their retention,

(e) Provision of other services to the Opioid Substitution Therapy client,

(f) Stock management: It should be ensured that the stocks of buprenorphine are properly maintained and replenished at regular intervals, so that there is no stock-out situation in the centre,

(g) Record maintenance: The prescribed records should be properly maintained at the Opioid Substitution Therapy centre,

Further details on the record maintenance and stock management can be found in the

document on standard operating procedure.

Management of Common Clinical Situations

During Opioid Substitution Therapy, a number of clinical situations may be encountered which require management by the service providers of the Opioid Substitution Therapy clinic.

VOMITING.—Vomiting does not occur commonly with buprenorphine-based Opioid Substitution Therapy.

Vomiting may occur in the initial period of initiation of buprenorphine, and usually subsides within a few days. The client may be prescribed oral anti-emetics, which can be administered half an hour before taking buprenorphine.

CONSTIPATION.—Constipation is a common side effect of buprenorphine-based Opioid Substitution Therapy.

A client complaining of constipation after buprenorphine initiation should be evaluated to rule out other causes of constipation. If an obvious cause is detected, appropriate treatment should be provided either by the Opioid Substitution Therapy doctor or through referral. Enquiry should also be made regarding any symptoms and signs of buprenorphine intoxication, such as increased drowsiness, gait abnormalities, slurring of speech, etc. If the symptoms or signs of buprenorphine intoxication are present, a careful reduction in dose may be helpful in relieving constipation. If no organic pathology is detected, conservative measures should be instituted initially. The client may be advised dietary change, increased consumption of water, increased physical activity, etc. If these measures do not improve constipation, the client may be prescribed laxatives. If all of these measures do not help improve constipation, the doctor should then consider decreasing the dose of buprenorphine. In many cases, constipation may be a trade-off — instead of experiencing constipation with the same dose of buprenorphine or undergoing the risk of withdrawal or relapse if the dose is lowered to relieve constipation.

SLEEP DISTURBANCE.—Sleep disturbance is common among Opioid Substitution Therapy clients, and include delayed initiation in sleep onset, or frequent waking up at nights. Very often, clients inject cocktails of opioids along with other sedative or hypnotics such as chlorphenaramine, promethazine or benzodiazepines. Additionally, the client may be abusing benzodiazepine tablets along with injecting drug use. During Opioid Substitution Therapy, while the opioid-related withdrawals are taken care of by administration of buprenorphine, withdrawals related to sedatives are not addressed, which leads to sleep disturbance.

If the client is dependent on benzodiazepines, management of benzodiazepine dependence must be undertaken independent of Opioid Substitution Therapy. For sleep disturbance, the client may be educated on sleep hygiene. If these measures fail, the client can be prescribed low dose benzodiazepines (tab.

diazepam or nitrazepam 5 to 20 mg at night) or other sleep-inducing medications such as mirtazapine (7.5 to 15 mg at night in tablet form), trazadone (50 mg at night in tablet form), or dothiepin (25 to 75 mg in tablet form). While prescribing benzodiazepines, it must be remembered that clients can also become habituated or dependent on benzodiazepine medications; hence the dose of benzodiazepines must be kept low and should be prescribed for the shortest duration possible.

SLEEP HYGIENE.—

(a) Fix the time for going to bed and getting up in the morning.

(b) Avoid afternoon naps.

(c) Have meals 2 hours before sleep.

(d) Avoid stimulants such as coffee, tea or nicotine after sunset.

(e) Avoid stimulating activities such as watching television before going to sleep.

(f) Take light exercise in the evening.

(g) Have a bath with warm water before going to sleep.

(h) Do light reading or listening to music before sleep.

(i) Use the bed only for sleep.

MISSED DOSES.—As Opioid Substitution Therapy is a long-term treatment and requires daily dosing, often clients miss their doses in-between and come back for treatment after a gap of a few days. In such situations, the management will depend on the duration of the missed treatment:

(i) If the client misses one day's dose of buprenorphine, the client can be given the same dose of buprenorphine as before.

(ii) If the client misses two–three days' dose of buprenorphine, enquiry must be made by the doctor regarding whether the client has consumed any opioids in the intervening period, or whether the client is in withdrawals currently. If the client is in withdrawals, he or she can be given the same dose as before. If the client has consumed any opioids in the intervening period, and he does not have withdrawals currently, the client may be given half the dose of buprenorphine and the dose can be gradually increased depending on the client's response in the subsequent days.

(iii) If the client misses his dose of buprenorphine for more than three days, the same dose of buprenorphine should not be given to the client, as tolerance to opioids can be lost even within three days. The client should be treated as a 'new' client and buprenorphine should be re- inducted, starting from induction phase till the client is stabilised.

Management of Special Clinical Conditions

CO-MORBID HIV INFECTION.—Service providers of Opioid Substitution Therapy intervention would commonly encounter Opioid Substitution Therapy clients who have been diagnosed with HIV infection, and are on Anti-Retroviral Treatment medications. The following points must be taken into consideration during co- morbid HIV infection:

(i) All efforts must be made to ensure that every Injecting Drug User client who is on Opioid Substitution Therapy should be referred to Integrated Counselling and Testing Centre for HIV testing after pre-test counselling. If the client is tested as HIV positive, he or she should be referred to Anti- Retroviral Treatment centre for registration and for decision on initiation of Anti-Retroviral Treatment medicines. If the client is HIV negative, he or she should be educated on high risk behaviours and strategies to prevent high risk behaviours as well as HIV prevention during high risk behaviours. The doctor need not wait for the HIV test results before initiation on Opioid Substitution Therapy.

(ii) If a client is already diagnosed as HIV positive during the initial assessment, the client can be initiated on Opioid Substitution Therapy and referred to Anti-Retroviral Treatment centre for the initial HIV-related assessment and investigations. The client can be stabilised on Opioid Substitution Therapy before initiation on Anti-Retroviral Treatment, which will help in improved adherence on Anti-Retroviral Treatment.

Though some drug-drug interactions are observed between buprenorphine and ART medications, these are often not clinically significant to warrant change in dose of either buprenorphine or ART medicines. The doctor should be guided by the clinical signs and symptoms for changing the dose of buprenorphine. If symptoms of opioid withdrawal are noticed or the client complains of discomfort after initiation of ART during Opioid Substitution Therapy maintenance phase, the doctor should increase and titrate the dose of1972 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] buprenorphine as per the client's comfort level. Similarly, the dose of buprenorphine should be decreased if the client complains of excessive drowsiness, slurring of speech, gait instability or other features of intoxication after initiation of ART medicines. A list of Anti-Retroviral Treatment medicines that can interact with buprenorphine is provided in Annexure A.

TUBERCULOSIS.—Tuberculosis is a common co-morbid condition among Injecting Drug Users. Hence, every client should be clinically assessed for tuberculosis during initiation on Opioid Substitution Therapy. If there is clinical suspicion, the client should be referred to a Tuberculosis centre for sputum testing and chest X-ray. The adherence to Tuberculosis treatment improves if the client is on Opioid Substitution Therapy. Some Tuberculosis medications can have interactions with buprenorphine. Rifampicin is a cytochrome p 350 enzyme inducer and can increase the clearance of buprenorphine. Isoniazid can cause hepatic damage, which in turn can alter the metabolism of buprenorphine. The doctor should titrate the dose of buprenorphine accordingly.

HOWEVER, SUSPECTED TUBERCULOSIS OR CURRENT ANTI-TUBERCULAR TREATMENT BY THEMSELVES DO NOT PRECLUDE WITHHOLDING OR DELAYING INITIATION OF OPIOID SUBSTITUTION THERAPY.

ADOLESCENTS.—While buprenorphine is now considered safe for use in anyone above the age of 12 years, the use of this medication for Opioid Substitution Therapy in population aged less than 18 years has not been as systematically studied as for the adult population. Usually, clients from this age-group have short duration of opioid use and even shorter duration of injecting drug use. As a result, a view held commonly by experts is that detoxification followed by antagonist treatment should be tried initially, and if this strategy fails, agonist medications should be considered. However, others are of the view that adolescents also have a high risk of sharing, overdose and other opioid-related complications, and hence, agonist treatment with buprenorphine should be considered for this population. Moreover, detoxification and antagonist treatments are not available everywhere, hence, it is not possible to wait for a trial of such treatments in every opioid-dependent adolescent.

If a client falls in the age group of less than 18 years, Opioid Substitution Therapy should not be denied straightaway. A careful assessment of the client's drug use and associated high risk behaviour should be made. Consideration must be given to the duration of opioid use, associated high risk behaviour, especially sharing of injecting equipment and sex-related behaviour. If there is a long history of opioid use (Less than 2 years) along with injecting drug use and associated high risk behaviour, Opioid Substitution Therapy with buprenorphine must be considered. There would be issues around obtaining informed consent, as consent from a person less than 18 years may not be considered valid. Hence, consent from either of the parents, or from a guardian (older than 18 years) may be obtained before initiating Opioid Substitution Therapy, besides obtaining the 'assent' from the minor client.

FEMALE POPULATION.—There are some special considerations with opioid dependent female patients who inject drugs. Females are more vulnerable to HIV and other complications due to injecting as compared to their male counterparts. More often than not, females have a male partner who is also an Injecting Drug User, as a result of which they have to use the injections and injecting equipment after the male uses them. Some female Injecting Drug Users resort to sex work to support their drug using habit. In addition, they also have to take care of children, which add to their burden. Female Injecting Drug Users are often looked down upon by the neighbours and the society, resulting in greater stigma and discrimination. Finally, female Injecting Drug Users have lesser accessibility to general healthcare services as well as HIV prevention programmes or drug treatment services. The staff of Opioid Substitution Therapy centre should bear these vulnerabilities in mind when attending to female Injecting Drug Users who wish to be initiated on Opioid Substitution Therapy.

PREGNANCY AND BREASTFEEDING.—OPIOID SUBSTITUTION THERAPY IS RECOMMENDED FOR PREGNANT WOMEN DEPENDENT ON OPIOIDS. The process of induction and maintenance is the same as for other patients. Care should be taken to ensure that termination of Opioid Substitution Therapy is not attempted in the first and the third trimester due to risk of abortion or pre-term delivery. The dose of buprenorphine may need to be increased in the third trimester due to increased volume of water during the third trimester of pregnancy. However, this should be done by clinical assessment for withdrawals. Buprenorphine should be continued throughout the labour. The dose of buprenorphine may need to be reduced after delivery. Buprenorphine should be continued after the delivery. Breast-feeding can be continued. Even though buprenorphine is secreted in breast milk, the actual amount of buprenorphine entering the infant's blood may not be high due to high first-pass metabolism.

The staff of the Opioid Substitution Therapy centre should inform the obstetrician and the neonatologist or paediatrician about the dose of buprenorphine that the client is on during delivery. The paediatrician should be made aware of the possibility of neonate experiencing opioid withdrawals after delivery, termed as Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome occurs due to the fact that the child in the mother's womb is exposed to buprenorphine. After delivery, buprenorphine levels fall in the child's blood due to non-availability of buprenorphine resulting in opioid withdrawals. Recent studies have shown that Neonatal Abstinence Syndrome with buprenorphine occurs in about one- third of all deliveries, and is mild to moderate in most cases. The clinical features and management of Neonatal Abstinence Syndrome is provided in Annexure B.

Medical termination of pregnancy should be offered, in case the client is not desirous of a child.

CONSIDERATIONS WHILE PROVIDING OPIOID SUBSTITUTION THERAPY INTERVENTION TO A FEMALE INJECTING DRUG USER.—

1. Special efforts must be made to make the female Injecting Drug User comfortable, as females are often reluctant to access services at places with predominant male Injecting Drug User clients.

2. The doctor and counsellor must ensure that the female Injecting Drug User is examined and interviewed in the presence of a female staff.

3. During assessment, enquiry must be specifically made regarding

a. Signs or symptoms of Sexually Transmitted Infection, as well as any high risk sexual behaviour

b. Last menstrual period to rule out pregnancy

c. Child-bearing history

d. Examination to rule out the presence of Sexually Transmitted Infection

4. Female Injecting Drug Users must be given priority during follow-up and dispensing of Opioid Substitution Therapy medicines and not-made to wait for their turn.

5. Presumptive Sexually Transmitted Infection treatment must be provided.

6. Contraceptives must be offered to those female Opioid Substitution Therapy clients in the child- bearing period and for those not desirous of having children.

7. Access to other psychosocial supportive services must be made available to those in need.

8. If the male partner is also an Injecting Drug User, efforts must be made to initiate the male partner on Opioid Substitution Therapy too.

Conclusions

Opioid Substitution Therapy is an effective treatment option for opioid dependence as well as HIV prevention intervention for opioid dependent Injecting Drug Users. The clinical practice of buprenorphine-based Opioid Substitution Therapy is simple and can be delivered by physicians with adequate training. A proper assessment must be conducted, and screening for Opioid Substitution Therapy criteria must be done before initiating a client on Opioid Substitution Therapy. Buprenorphine is relatively a safer medicine to use. Appropriate client selection, an adequate dose of buprenorphine as well as for an adequate duration is an important determinant of a successful Opioid Substitution Therapy intervention. The attitude of staff towards the clients, combined with other issues such as dispensing hours of the clinic, provision of ancillary services are other important determinants of the success of Opioid Substitution Therapy intervention.

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4. US Department of Health and Human Service, Substance Abuse and Mental Health Service Administration, Centre for Substance Abuse Treatment, 2004.

5. Connock M, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technology Assessment, 2007; vol 11, No. 9.

6. Dhawan A, Jain R, Chopra A. Opioid substitution — Buprenorphine in India: A study report. United Nations Office on Drugs and Crime, Regional Office for South Asia, 2010.

7. Dhawan A, Jhanjee S. Manual for long-term pharmacotherapy. National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, 2013.

8. Dorabjee J, Samson L. Self and community based opioid substitution among opioid dependent populations in the Indian sub-continent. International Journal of Drug Policy, 1998; 9: 411-416.

9. Effectiveness of drug dependence treatment in preventing HIV among Injecting Drug Users. World Health Organisation, 2005.

10. Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. World Health Organisation, 2009.

11. Kumar MS, Natale RD, Langkham B, Sharma C, Kabi R, Mortimore G. Opioid substitution treatment with sublingual buprenorphine in Manipur and Nagaland in Northeast India: what has been established needs to be continued and expanded. Harm Reduct J. 2009 Feb 26;6:4.

12. Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev.2008 Apr 16;(2):CD002207.

13. Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement for opioid dependence. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD002209.

14. Metzger DS, Woody GE, McLellan AT, O'Brien CP, Druley P, Navaline H, DePhilippis D, Stolley P, Abrutyn E. Human immunodeficiency virus seroconversion among intravenous drug users in- and out- of-treatment: An 18-month prospective follow-up. J Acquir Immune DeficSyndr. 1993 Sep;6(9):1049– 1056.

15. Operational guidelines for the management of opioid dependence in the South-East Asia region.World Health Organisation, Regional Office for South-East Asia, 2008.

16. Rao R, Ambekar A, Agrawal A. Opioid substitution therapy under National AIDS Control Programme – A situational Analysis. National Drug Dependence Treatment Centre, All India Institute of Medical Sciences. Prepared for Global Fund Round 9 Injecting Drug User-HIV grant project 'Hifazat'.

17. Rao R, Ambekar A, Yadav S, Sethi H, Dhawan A. Slow-release oral morphine as a maintenance agent in opioid dependence syndrome: an exploratory study from India. Substance use and misuse, 2012; 17: 294—300.

18. Ray R, Dhawan A, Ambekar A. Implementing Opioid Substitution Therapy —A training manual for service providers.

19. National AIDS Control Organisation, Government of India, 2011.

20. Substance use disorders, Manual for physicians. National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, 2013.

21. WHO or United Nations Office on Drugs and Crime or Joint UN Programme on HIV or AIDS position paper. Substitution maintenance therapy in the management of opioid dependence and HIV or AIDS prevention. World Health Organisation, United Nations Office on Drugs and Crime, Joint United Nations Programme on HIV or AIDS, 2004.

Annexures

Annexure A: Buprenorphine Interactions with Anti-

Retroviral Medicines

No major interactions observed or reported.

Annexure B: Neonatal Abstinence Syndrome

(Adapted from: Operational guidelines for the management of opioid dependence in the South-East Asia region, World Health Organisation, Regional Office for South-East Asia, 2008).

CLINICAL FEATURES.— Babies born to mothers on buprenorphine should be monitored after delivery. Specific assessment tools can be used to track the signs and symptoms of neonatal abstinence syndrome (NAS). Modified Finnegan Neonatal Abstinence Syndrome Score (NASS) can be used for this purpose. The scoring should be initiated two hours after birth and repeated every four hours. Pharmacological treatment is initiated when three consecutive scores average more than or equal to 8, or when two consecutive scores are more than or equal to 12.

Modified Finnegan Neonatal Abstinence Syndrome Score chart for term infants:

TREATMENT.—General nursing care should be provided. Keeping the baby warm, close contact with the mother, etc. should be provided to the baby.

PHARMACOLOGICAL TREATMENT.—Opioids are the preferred medicines of choice. Morphine elixir 1mg/ml can be used to treat Neonatal Abstinence Syndrome. Initiate with 0.02 mg/kg body weight orally at every 4 to 6 hour interval till the desired response. Maintain the same dose for 3 to 5 days, and then taper by 10% of the total dose every 2 to 3 days. Vital signs and oxygen saturation should be monitored during opioid-based treatment. Care should be taken not to induce opioid toxicity or overdose in the neonate due to administration of a higher dose of morphine. Morphine overdose may manifest as narcosis, poor reflexes, decreased suckling, and poor response to pain, and can lead to coma, decreased breathing, hypothermia and bradycardia. In such cases, respiratory support should be provided; naloxone should be avoided as it can cause withdrawal seizures.

Sedatives are the second choice for treatment of Neonatal Abstinence Syndrome. Control of symptoms and seizures are not as effective as with opioids. Phenobarbitone 5 mg/kg/day in two divided doses can be given.

The neonate should be hospitalised till 4 weeks of delivery along with the mother for complete recovery. Breastfeeding must be continued in the meantime.

नई दिल्ली, 14 अगस्त, 2020

मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 की उप-धारा (1) उपबंध करती है कि केन्द्रीय सरकार सामान्यतः उक्त अधिनियम के उपबंधों को कार्यान्वित करने हेतु, उक्त अधिनियम और उसकेे अधीन बनाए गए किन्ही नियमों से संगत मार्गदर्शन बना सकेगी;

और उक्त धारा की उप-धारा (2), अन्य बातों के साथ-साथ, केन्द्रीय सरकार को एनएसीपी III परिचालन मार्गदर्शनों के अधीन लक्षित हस्तक्षेप -प्रवासी और ट्रक ड्राइवर के प्रयोजनार्थ परिचालन मार्गदर्शन बनाने के लिए सशक्त करती है;

अतः, अब केन्द्रीय सरकार मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए इस अधिसूचना से उपाबद्ध अनुसूची के अनुसार एनएसीपी III के अधीन लक्षित हस्तक्षेप (प्रवासी और ट्रक ड्राइवर) परिचालन मार्गदर्शन, 2018 अधिसूचित करती है।

[फा. सं. टी-11020/50/1999-नाको (पी एंड सी)]

आलोक सक्सेना, संयुक्त सचिव

New Delhi, the 14th August, 2020

S.O. 683.—Whereas sub-section (1) of section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017) provides that the Central Government may make guidelines consistent with the said Act and any rules made there under, generally to carry out the provisions of the said Act;

And where sub-section (2) of the said section, inter alia, empowers the Central Government to make guidelines for the purposes of the Targeted Interventions Under NACP III Operational Guidelines – Migrants and Truckers;

Now, therefore, in exercise of the powers conferred by section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017), The Central Government hereby notifies the Targeted Interventions Under NACP III (Migrants and Truckers) Operational Guidelines, 2018 as per the Schedule annexed to this notification.

[F. No. T-11020/50/1999-NACO(P&C)]

ALOK SAXENA, Jt. Secy.

SCHEDULE

"Targeted Interventions

Under NACP III

MIGRANTS AND TRUCKERS"

OPERATIONAL GUIDELINES, 2018

FOREWORD

K. Sujatha Rao

Additional Secretary & Director General

National AIDS Control Organisation, Ministry of Health & Family Welfare, Government of India

The prevention of new infections in High Risk Groups is a major thrust in National AIDS Control Programme III. The most effective means of controlling the spread of HIV in India is through the implementation of Targeted Interventions (TIs) amongst persons most vulnerable to HIV or AIDS, such as female sex workers, Men Who Have Sex with Men and Transgenders and Injecting Drug User. In addition, the Bridge Populations of truckers and migrants also require focused interventions. Both National AIDS Control Organisation and the States place a high priority upon full coverage of the States' Female Sex Workers, Men Who Have Sex with Men or Transgenders, Injecting Drug Users and migrants or truckers with Targeted Interventions. In order to standardise the approach to scaling up coverage among these core groups and Bridge Populations and maintain a high level of quality, it is important to provide detailed information on various operational issues in Targeted Interventions.

National AIDS Control Organisation has prepared these Operational Guidelines after a series of consultations with Technical Resource Groups, representatives of civil society, Government, core groups, donors and other stakeholders. The guidelines describe the operational details of Targeted Intervention projects with various core High Risk Groups (Part 1) and Bridge Populations (Part 2). The guidelines also provide detailed information on issues related to programme management, services required in terms of human resources, infrastructure, linkages and Monitoring and Evaluation indicators for each programme area.

I take this opportunity to acknowledge the contribution made by the Technical Resource Groups, the Targeted Intervention Team of National AIDS Control Organisation and the National AIDS Control Organisation Technical Support Unit in preparing these guidelines. I would also like to acknowledge and thank the various agencies mentioned in the acknowledgments section for their valuable inputs.

We hope that these guidelines will help State AIDS Control Societies, potential partners (Non-Governmental Organisations, Community Based Organisations, and networks), programme managers and other staff working in Targeted Intervention projects and Technical Support Units to implement and manage Targeted Intervention projects more effectively.

Let the scale up challenge begin!

9th Floor, Chandralok Building, 36 Janpath, New Delhi 110001 Phone: 011 23325331 Fax: 011 23731746

E mail: [email protected]

TABLE OF CONTENTS MIGRANTS AND TRUCKERS

Foreword

Acknowledgements 5

8

10 Introduction: Migrants 11 Chapter 1

Introduction to Targeted Interventions for Migrants Under National AIDS Control Programme III

20 Chapter 2

Operationalising Targeted Interventions for Migrants:

Guidelines for State AIDS Control Society and Technical Support Unit

35 Chapter 3

Implementing Targeted Interventions for Migrants:

Guidelines for Non-Governmental Organisations

Annexures: Migrants 62

Introduction: Truckers

Chapter 1

Introduction to Targeted Interventions for Truckers Under National AIDS Control Programme III

Chapter 2

Operationalising Targeted Interventions for Truckers:

Guidelines for State AIDS Control Society and Technical Support Unit

Chapter 3

Implementing Targeted Interventions for Truckers:

Guidelines for Non-Governmental Organisations

Annexures: Truckers

List of Annexures Migrants

National AIDS Control Organisation Guidelines and Tools Referenced in these Guidelines

Non-Governmental Organisation or Community Based Organisation Guidelines, March 2007

Guidelines on Financial and Procurement Systems for Non-Governmental Organisations or Community Based Organisations, March 2007

Targeted Intervention Costing Guidelines

Sexually Transmitted Infection Guidelines

ACKNOWLEDGEMENTS

The following individuals and organisations are acknowledged for their work which is quoted or used in adapted versions in the text of the Guidelines and the Annexures:

Migrants:

(1) Bill and Melinda Gates Foundation

(2) CARE India

(3) Department for International Development

(1) Rabo Capital Securities Limited

(4) India Health Action Trust, University of Manitoba

(5) Population Services International

(6) International Labour Organization

Truckers:

(2) Bill and Melinda Gates Foundation

(3) Rabo Capital Securities Limited

(4) Mr.Bhagavandas, Citizens Alliance For Rural Development and Training Society

(5) Therapeutic Crisis Intervention for Families

(6) Aparajita Bhalla

National AIDS Control Organisation Technical Support Unit for Targeted Interventions

(i) Aparajita Ramakrishnan, Team Leader, National AIDS Control Organisation Technical Support Unit (The Bill and Melinda Gates Foundation);

(ii) Nandinee Bandyopadhyay, Targeted Interventions Team, National AIDS Control Organisation Technical Support Unit (PATH);

(iii) Senthil K. Murugan, Targeted Interventions Team, National AIDS Control Organisation Technical Support Unit (University of Manitoba);

(iv) Amit Shrivastav, Targeted Interventions Team, National AIDS Control Organisation Technical Support Unit (Family Health International);

(v) Meera Mishra, National AIDS Control Organisation Technical Support Unit (Constella Futures);

Technical Resource Group for Bridge Populations

1. Chair: Ms.Sujatha Rao, Additional Secretary & Director General, National AIDS Control Organisation, Ministry of Health & Family Welfare, Government of India

2. Representative of Care India involved in HIV Programme, New Delhi

3. Mr. Ashok Alexander, Bill and Melinda Gates Foundation

4. Dr. James Blanchard or Dr.Priyamvada Singh, IHAT, Rajasthan

5. Mr.Akhil Kumar Jain, Member Administration, NHAI

6. Dr.Sundar Sundararaman, Freelance Consultant

7. Dr. K. Sudhakar, CDC, New Delhi

8. Mr. Manoj Gopalakrishnan, Chief Executive Officer, HLLFPPT, New Delhi

9. Dr. Rajesh Kumar, SPYM, New Delhi

10. Director, V.V. Giri National Labour Institute (NLI), Noida

11. Dr.Smarajit Jana, National Consultant, United States Agency for International Development

12. Mr. S.M. Afsar, Project Coordinator, International Labour Organization

13. Mr. R. Elango, President, INP+, Chennai

14. Sh. O.P.Aggarwal, All India Motor Transport Congress, Delhi

15. Mr. T. K. Malhotra, Federation of Indian Automobile Association

16. Representative from Population Services International, New Delhi

17. Representative from Transport Corporation of India

INTRODUCTION : MIGRANTS

The purpose of these guidelines is to ensure the delivery of quality HIV prevention interventions to high risk migrant populations in India. The guidelines outline standardised operating procedures for implementing comprehensive HIV prevention services for migrant populations.

These guidelines have been developed with the following audience in mind:

(1) State AIDS Control Societies



(2) Technical Support Units



(3) Implementing partners (Non-Governmental Organisations or Community Based Organisations)

It is recommended that all organisations using these guidelines consider each of the proposed elements in the context of the organisation's current environment and other relevant guidelines such as Non-Governmental Organisation or Community Based Organisation Guidelines, National AIDS Control Organisation, March 2007 and Guidelines on Financial and Procurement Systems for Non-GovernmentalOrganisations or Community Based Organisations, National AIDS Control Organisation, March 2007.

CHAPTER 1

Introduction to Targeted Interventions for Migrants Under National AIDS Control Programme III

TABLE OF CONTENTS

1.1 RATIONALE FOR TARGETED INTERVENTIONS

AMONG MIGRANTS

1.1.1 Role of Migration in HIV Transmission

1.1.2 Definition of Migrants for Targeted Intervention Purposes

1.1.3 Significance of the Bridge Population in HIV Epidemics

1.1.4 Sources of Risk and Vulnerability for Male Migrants

1.1.5 Sources of Risk and Vulnerability for Female Migrants

1.2 CONSIDERATIONS FOR MIGRANT PROGRAMMING

1.2.1 Targeting High Risk Migrant Men

1.2.2 Targeting High Risk Migrant Women

1.2.3 Linking Migrants at Source and Destination Points

1.2.4 Intervention Package for High Risk Migrants Covered under Targeted

Interventions

1.1 RATIONALE FOR TARGETED INTERVENTIONS AMONG MIGRANTS:

1.1.1 Role of Migration in HIV Transmission An important source of HIV related vulnerability is mobility and migration, mobility being defined as a change of location and migration being defined as a change of residence.

India, home to the third highest number of HIV positive people in the world, is characterised by widespread and fluid migration and mobility. More than 2 million Indians do not live in the place of their birth. While mobility in other parts of the world is inhibited by national boundaries, there are few land masses the size of India with such a good transport infrastructure as this country.

Once migrants reach their destination, language and other difficulties lead to feelings of discontinuity and transition that enhance loneliness or sexual risk taking. Such risk taking may be reinforced by a lack of HIV or AIDS awareness, information and social support networks at both source and destination points, which cumulatively contribute to a migrant's vulnerability.

Back home, spouses of migrants are also vulnerable to HIV if their husbands return on a regular basis and have become infected with HIV. Some wives also have their own sexual networks during their husband's absences.

It is important to note that not all migrants are at equal risk of HIV. It is those men who are part of sexual networks at their destinations – either with Female Sex Workers or with other men (Men Who Have Sex with Men) or Transgenders – who are more prone to HIV infection. Similarly, those female migrants who take up transactional sex at destination locations are at greatest risk of HIV.

1.1.2 Definition of Migrants for Targeted Intervention Purposes Classification of migrants from an HIV vulnerability perspective is based on the following key criteria:

(a) Intersection with high risk sexual networks;

(b) Pattern, degree and duration of mobility and migration;

(c) Age;

(d) Whether moving singly or with family;

(e) Route of migration;

(f) Destination of migration.

Based on these criteria, the definition of migrants is:

Single men and all women in the age group of 15 to 49 years

who move between source and destination within the country once or more in a year.

Those who return to their source location at regular intervals are called "circular migrants".

Note: Interventions at the "source" villages or towns or States (i.e. for "out­migrants") do not fall

under Targeted Interventions for migrants; if at all, they are covered under other schemes (e.g.

Link Workers).

1.1.3 Significance of the Bridge Population in HIV Epidemics:

The broader transmission of HIV beyond High Risk Groups (which include Female Sex Workers, Men Who Have Sex with Men and Transgenders, Injecting Drug Users) often occurs through their sexual partners, who also have lower risk sexual partners in the "general" population.

(a) For example, a client of a sex worker might also have a wife or other partner who is at risk of acquiring HIV from her higher risk partner;

(b) And a migrant woman who engages in sex work at her destination point may return to her spouse or partner at home, putting him at risk of HIV infection.

Individuals who have sexual partners in the highest risk groups as well as other partners of lower risk (general population) are called a "Bridge Population", because they form a transmission bridge from the key population to the general population. Men are an important Bridge Population in HIV epidemics for several reasons:

(a) Men are more likely to have multiple partners than women;

(b) Men influence the 'demand' side of sex work which determines the size and distribution of sex worker populations at destinations.

This is illustrated in Figure 1.1. In this pattern of epidemic transmission, it is most effective and efficient to target prevention towards the High Risk Group and Bridge Population members to keep their HIV prevalence as low as possible.

"General" Population

"General" Population

"General" Population

Bridge

Bridge

Bridge

"General" Population

Bridge

Bridge

"General" Population

High Risk Groups

Bridge

Bridge

"General" Population

"General" Population

Bridge

Bridge

Bridge

"General" Population

"General" Population

"General" Population

Figure 1.1 Illustration of an HIV Transmission Network

High risk migrants who are targeted through Targeted Interventions are thus either in the Bridge Population category– that is as clients of High Risk Group members (e.g. Female Sex Workers, Men Who Have Sex with Men, Injecting Drug Users) – or are High Risk Group members themselves (as Female Sex Workers, Men Who Have Sex with Mens or Injecting Drug Users). Migrant interventions will focus on providing services to bridge population high risk men. Any migrant identified as an High Risk Group member can be referred to the nearest.

Targeted Intervention for that risk group.

1.1.4 Sources of Risk and Vulnerability for Male Migrants (a) Relative freedom in the new setting as well as peer pressure to experiment with new norms;

(b) Distress migration driven by seasonal drought or disasters;

(c) Loneliness, drudgery and long periods of separation from spouse or sexual partner;

(d) Having disposable income, clubbed with limited choices for affordable entertainment and recreation. This usually means drinking and, sometimes, drugs as well as sex with Female Sex Workers and other casual sex relationships.



1.1.5 Sources of Risk and Vulnerability for Female Migrants (a) Poverty (usually reason for migrating in the first place) makes women more vulnerable to being pushed in to sex work at their destination to supplement their earnings;

(b) Lack of HIV and AIDS awareness, information and social support networks at both source and destination points;

(c) Loneliness, drudgery and long periods of separation from family or spouse or sexual partner;

(d) Limited or no skills to cope with the overall pressures and environment at destination places. This may lead to behaviours associated with risk for HIV infection, i.e. drinking and sometimes drugs as well as sex with male colleagues, casual sex relationships or sex work;

(e) Risk of being trafficked along the way and the risk of sexual exploitation, violence or harassment by sexual network operators or local power structures or by colleagues or supervisors or contractors in the workplace;

(f) Lack of knowledge and negotiation skills make it difficult for women to negotiate condom use with their husbands and other sexual partners;

(g) Lack of decision making power and reticence about seeking Sexually Transmitted Infection treatment often lead to a suppressed demand for health services even when the need is obvious. This results in prolonged untreated Sexually Transmitted Infections and increases the risk of HIV infection;

(h) Lack of awareness of policies and laws which promote women's rights to reproductive and sexual health and equal access to education and information on health care.

1.2 CONSIDERATIONS FOR MIGRANT PROGRAMMING:

1.2.1 Targeting High Risk Migrant Men:

India's male migrant population is very large and diverse, and since only a small proportion can be reached with HIV programmes the focus should be on those at highest risk.

Figure 1.2 illustrates two main strategic issues:

(a) First, only a proportion of all sex worker clients are migrants. This proportion will vary by location.

(b) Second, most migrants are not clients of sex workers (either Female Sex Workers

or high risk Men Who Have Sex with Men).

Male Clients Targeted

ntervention

Female Male Migrants Sex Workers

Figure 1.2. Population Approach to Targeted Interventions for Migrant Men

Therefore, the emphasis of the Targeted Intervention strategy for male migrants should be on the subset of men who are both migrants and part of high risk sex networks, usually as clients of Female Sex Workers or of high risk Men Who Have Sex with Men.

Since many men who have sex with Female Sex Workers, high risk Men Who Have Sex with Men and Transgenders also have other partners, both male and female, focused interventions for these Bridge Populations are strategically critical to controlling the HIV epidemic.

This focused intervention approach is indicated in Figure 1.2. This approach ensures that the intervention is cost effective, since resources will be directed to where HIV prevention is most critical.

This approach requires the gathering of strategic information on both the location of large concentrations of male migrants and their interaction with local Female Sex Workers or high risk Men Who Have Sex with Men as clients, or in the case of female migrants, their participation in transactional sex.

Mapping exercises (see Chapter 2 below) can identify the confluence of migrant men with High Risk Group networks to keep interventions focused on those migrant men who are actually at risk and on the locations where risk occurs.

1.2.2 Targeting High Risk Migrant Women

As discussed above, female migrants are largely at risk due to the possibility of engaging in transactional sex, either through coercion or to supplement their income. To that extent, high risk migrant women are entitled to receive the same package of services as female sex workers. The needs assessment conducted at the start of the project should share information on known high risk female migrants with the closest Non-Governmental Organisation implementing Targeted Interventions for female sex workers so the Non-Governmental Organisation can plan to include them in services.

1.2.3 Linking Migrants at Source and Destination Points

In spite of the fact that migration is a continuum with different stages – source, transit, and destination point – the bulk of HIV related migration programming is directed as Targeted Interventions towards migrants in their urban destinations. As a result, where migrants come from, how they travel and the situation of their families left behind remain largely unaddressed by stand­alone destination­based interventions. This means that migrants' emotional, social and support needs before departure, during travel, and in the destination State/s are difficult to meet. Destination based programmes often have Outreach Workers who speak different languages and have different cultural backgrounds.

There is therefore a strong need and a rationale for establishing effective linkages between source and destination programmes. An engaged source State can motivate and support destination States to address specific migrant sub populations under their HIV prevention and care programmes, e.g. Rajasthani or Bihari or Gujarati or Kannada migrants. Based on the mapping data from destination States (shared with the source State AIDS Control Society by the destination State AIDS Control Society), the State AIDS Control Society should take the responsibility of covering migrant wives or sexual partners, through link workers and as part of broader State AIDS Control Society supported HIV or AIDS initiatives in the major pockets of high outward migration.

Such links between source and destination programmes are most efficiently established through a Memorandum of Understanding between the State AIDS Control Society of the destination and source States (an Memorandum of[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1989 Understanding may be signed between two State AIDS Control Society or a group of State AIDS Control Society). An Memorandum of Understanding provides a constructive framework for HIV prevention intervention by developing a coordination mechanism assuring the required support for the interventions. See Paragraph 2.2.2.B for more information.

1.2.4 Intervention Package for High Risk Migrants Covered under Targeted Interventions

CHAPTER 2

Operationalising Targeted Interventions for Migrants:

Guidelines for State AIDS Control Society and

Technical Support Unit

TABLE OF CONTENTS

2.1 MAPPING MIGRANT COMMUNITIES – GEOGRAPHIC MAPPING, SIZE ESTIMATION AND

SITE ASSESSMENT

2.1.1 Identifying Intervention Areas

A. Step 1: Review and analysis of existing data sources Data analysis

Risk assessment study

B. Step 2: Supplemental mapping1990 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Preliminary mapping (Identifying sub pockets of risk) Detailed mapping (Identifying locations and populations for intervention) Understanding source areas for migrants

2.2 Recruitment and Capacity Building

2.2.1 Contracting Non-Governmental Organisations for Targeted Interventions

2.2.2Roles of Partner Agencies

A. National AIDS Control Organisation

B. State AIDS Control Society

Advocacy with Government departments

Advocacy for workplace policies and programmes

Linking programmes in destination and source State AIDS Control Society

Engage industry or workplace institutions, employers' associations, other allied organisations and structures

C. Non-Governmental Organisations and other implementers (including workplace Non-Governmental Organisations)

D. Other Government departments

E. Core group Targeted Intervention partners

F. Social Marketing Organisations

G. Other development agencies

H. Summary table

2.2.3 Capacity Building

A. Linkages with other HIV programmes

B. Capacity building approaches

At State AIDS Control Society level

At implementing agency level

Steps in Mapping and Non-Governmental Organisation Selection

                                                     (a)   Review of existing data sources
Estimating the extent and nature of HIV risks and    
vulnerabilities among migrants through mapping       (b)   Risk assessment study

(c) Supplemental mapping



(a) Contracting Non-Governmental Organisations or other implementing agencies (b) Roles of partner agencies

Recruitment and capacity building

(c) Capacity Building for Non-Governmental

Organisations and State AIDS Control Society

2.1 MAPPING MIGRANT COMMUNITIES – GEOGRAPHIC MAPPING, SIZE ESTIMATION

AND SITE ASSESSMENT

2.1.1 Identifying Intervention Areas[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 1991

A. Step 1: Review and analysis of existing data sources

This is done through a state level analysis to locate large pockets of migrants, and a risk assessment study to ascertain if there are significant numbers who are at risk for HIV.

Data analysis

Analyse data from National Sample Survey, Census and National Commission of Rural Labour to map major pockets of migrants in the state, where there are 5,000 10,000 single male circular migrants (as defined in Paragraph 1.1.2 above) living within a radius of 5 10 kilometres. This process should be undertaken by the State AIDS Control Society of the destination states. The review and analysis should be shared with the potential partner agencies to facilitate their understanding and enable them to move on to the next stage.

Risk assessment study

Contract an agency (preferably a local one and backed by Technical Support Unit) to conduct a risk assessment study to decide if these migrants are at risk based on the following criteria:

1. Had sex with a non regular partner in the last 12 months

2. Different types of sexual partners for the risk population

3. Profile of risk population

4. Condom related indicators

5. Proportion who suffered from Sexually Transmitted Infections in the last 12 months

6. Proportion who sought treatment from a qualified practitioner for Sexually Transmitted Infections 7. Proportion who feel it is important to know HIV status

8. Proportion who intend to get themselves tested

9. Proportion who feel at high risk with a female partner if they have sex in exchange for money or in kind

10. Proportion who have correct knowledge about the modes of HIV transmission

Annexure 1, Risk Assessment provides details on the types of interviews conducted, sample size, etc. This exercise will provide details as to which "slums" or "migrant areas" require intervention, if any.

Unless the risk assessment study finds that the population in a given area is at

GREATER risk than the average male population (defined in terms of the criteria

above), there is no need for a Targeted Intervention there.

For example, the National Behavioural Surveillance Survey 2001 indicates that ~10% of Indian men have had sex with a non regular partner in the last 12 months. For migrant interventions to be necessary for a given population, this percentage must be much higher – e.g. in Dharavi this figure was >40% (according to a survey by Population Services International).

B. Step 2: Supplemental mapping When no information exists, or it is not available through the state level analysis of large pockets of migrants, a mapping and situation assessment should be conducted with the following considerations in mind:

(i) Geographic approach – High risk sexual networking is often geographically clustered and is frequently linked directly to a range of vulnerable populations including migrants. Mapping should therefore1992 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] identify priority locations for initiating and scaling up Targeted Interventions for all vulnerable populations.

Moreover, this information should be augmented by a comprehensive situation and needs assessment for the local planning of supportive services such as condom promotion, voluntary counselling and testing, Sexually Transmitted Infection services and care, treatment and support. By prioritising locations, the full range of prevention, care and support services can be clustered more appropriately to enhance efficiencies and integration of programme components needed for any migrant intervention.



(ii) Need to focus on large "catchment" areas for efficient programming – Migrant programmes at destination should cover geographic areas which contain concentrations of migrant populations in conjunction with sex work concentration. It is therefore important to map pockets or villages or slums which have a high concentration of circular migrants (as opposed to relocated migrants) and overlay this mapping on sex worker concentration data from Targeted Interventions with Female Sex Workers.

The emphasis of the mapping exercise for migrant Targeted Interventions should be on identifying migrant men and women who form a part of high risk sexual networks, usually as clients of sex workers or high risk Men Who Have Sex with Men or Transgenders or as practising sex workers themselves.

Mapping focuses on three kinds of intervention sites:

(a) Hotspots (points of sex solicitation);  (b) Prioritised industry or workplace centres;  (c) Large residential centres.

A dual layer location mapping (preliminary and detailed) is required to identify sub pockets of risk within larger locations and to gather information for intervention purposes.

Preliminary mapping (identifying sub pockets of risk)

Preliminary mapping provides a general overview of the entire geographic area and is the basis for the refined methods and tools necessary for a detailed mapping study. Mapping is to be done by Outreach Workers who are given training in the methodology, preferably by Technical Support Unit by an agency hired by State AIDS Control Society. Preliminary mapping will include a geographic area overview and interviews with Key Informants to help identify:

(i) Congregation points of high risk men

(ii) Presence of sex workers

(iii) Presence of elements such as video parlours, youth clubs or mandals, Non-Governmental Organisations, temples, hotels, lodges, bars and movie theatres that could be vantage points for target efficient field communication

The Key Informants in each area include shopkeepers, cinema hall employees, slum residents, housing colony residents, slum development officers, municipal corporation officers, private doctors, government hospital doctors, Non-Governmental Organisations, industry employers and employees, labour contractors, bar owners and clientele, railway station masters and bus depot in charges.

See Annexure 2, Mapping Methodology and Annexure 3, Preliminary Mapping.

Detailed mapping (identifying locations and populations for intervention)

Detailed mapping is needed in order to ensure a target efficient, streamlined intervention among migrant workers. This study will:

(i) Assess the target group size of high risk migrant men and women

(ii) Identify target efficient hotspots or strategic locations

(iii) Determine possible range of communication activities to be conducted at the identified hotspots

(iv) Assess the presence of sex workers in the area along with the type of sex work and the typology of the sex workers

The detailed mapping study will be done by Outreach Workers, preferably trained by the Technical Support Unit or an agency hired by the State AIDS Control Society, using three primary components:

1. A detailed mapping tool that provides information on target group size as well as congregation points of high risk men and women (see Annexure 4,Detailed Mapping).

2. An Female Sex Workers assessment that provides information on sites of sex work as hotspots for field communication activities and services (see Annexure 5,Female Sex Workers Assessment).

3. A screening of mandals or youth clubs and video parlours or other sites that provides information on high risk men and women who are part of sexual networks. Also the potential types and frequency of field communication activities (see Annexure 6,Hotspot Screening (Owners)and Annexure 7, Hotspot Screening (Patrons)).

Understanding source areas for migrants

While conducting mapping at the destination sites, an attempt should be made to identify source States, including the details

of village or town or District clusters. This information should be communicated to the State AIDS Control Society of the

source State to facilitate outreach to the migrant spouses or sexual partners back home and to returning migrants. See

Paragraph 1.2.3 for more information.

Tools

Annexure 1 Risk Assessment

Annexure 2 Mapping Methodology

Annexure 3 Preliminary Mapping

Annexure 4 Detailed Mapping

Annexure 5 Female Sex Workers Assessment

Annexure 6 Hotspot Screening (Owners)

Annexure 7 Hotspot Screening (Patrons)

2.2 RECRUITMENT AND CAPACITY BUILDING

2.2.1 Contracting Non-Governmental Organisations for Targeted Interventions

Non-Governmental Organisations and other implementing agencies (e.g. unions, registered youth groups) will be contracted to implement Targeted Interventions for a population of at minimum 5,000 migrants.

Non-Governmental Organisations or other implementing agencies should be selected and contracted based on the mapping and situation assessment findings and National AIDS Control Organisation's Non-Governmental Organisation or Community Based Organisation Guidelines. Preference may be given to Non-Governmental Organisations or organisations that are already working with migrant communities in urban slum areas on other issues (such as water and sanitation, other basic urban services health, literacy or education, etc.), since they have familiarity and access to migrants and have gained their trust.

The Non-Governmental Organisation is to hire staff as per the following ratios:

(a) Volunteer Peer Leaders at a ratio of 1 Volunteer Peer Leader to 100 migrants;  (b) Outreach Workers at a ratio of 1 Outreach Worker to 10 Volunteer Peer Leaders;  (c) Communication team(s) (street theatre or play teams);  (d) Coordinator at a ratio of 1 coordinator to 5 Outreach Workers;  (e) One part time doctor for clinic;  (f) One counsellor;  (g) One part time accountant.

The Outreach Workers and Volunteer Peer Leaders will receive proper induction training covering all aspects and

components of migrant programming, including the social marketing of condoms. The details of capacity building needs and1994 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] planning for the same are described in Paragraph 3.1.2.D (refer also to Section 8 of the Non-Governmental Organisation or Community Based Organisation Guidelines, National AIDS Control Organisation, March 2007).

The following table summarises the coverage and personnel or volunteers ratio under a migrant Targeted Intervention:

2.2.2 Roles of Partner Agencies

A. National AIDS Control Organisation

(a) Advocate with key funding sources to ensure that all infrastructure development projects incorporate a clause for construction and other contractors to provide HIV or AIDS prevention and referral services (as was done in the case of certain projects implemented by the World Bank or Asian Development Bank); Dialogue with Labour Department or Ministry for systematic data collection on migration (as part of the larger mainstreaming agenda with the Labour Department or Ministry);

(b) Through Panchayati Raj Institutions, facilitate the active maintenance of the "migration register" at village level.

This can be done at all Panchayats;

(c) Coordinate information sharing between State AIDS Control Society to enable coverage of known source locations through link workers.

B. State AIDS Control Society

Advocacy with Government departments

Government departments play a critical role in both service provision and addressing the underlying causes of distress migration. Safe migration is a factor of informed choice. Much is being done for provision of information on HIV or AIDS, safe sex, available services, etc., but very little on improving choices for migrants, especially in the source areas. Based on mapping of high out migration areas, State AIDS Control Society must advocate with concerned government departments to implement programmes for livelihoods, self employment, micro credit, vocational training, etc. in line with their comparative strengths. This could include government departments such as Panchayati Raj Institution, Rural Development, Horticulture, Khadi and Gramodyog, Department of Women and Child, Education (vocational and skill based), etc.

Advocacy for workplace policies and programmes

As per National AIDS Control Organisation's letter issued to all State AIDS Control Society in April 2006, State AIDS Control Society should link with small and large scale employers of migrants to advocate for workplace policies and programmes (see Annexure 8,HIV or AIDS Workplace Policies). A large number of industries or workplaces engage migrant workers as regular and part time workers. These may include clusters of small industries or workplaces (e.g. Pimpri Chinchwad near Pune, Wazirpur and Bhwari near Delhi) or large industrial houses such as Jindals, Reliance, Jubilant Organosys which are located in remote areas and require workers to migrate to those locations on a short term basis.

While the large industries or workplaces have a Corporate Social Responsibility strategy, few of them include HIV or AIDS in this. Possible actions with medium and large industries or workplaces include:

(a) Development and implementation of workplace policies to protect their workforce from HIV or AIDS and provide care and support to those infected;

(b) Advocacy to include HIV or AIDS services into their Corporate Social Responsibility strategy, including provision of outreach, prevention and care services in their catchment areas. Best practice examples of HIV or AIDS policy for the workplace from Gujarat Ambuja and TCIL are included in Annexure 8. For smaller industries or workplaces, activities will include:

(c) Mapping of industry or workplace clusters (with initial cues from business organisations such as Rotary and Lions Clubs which have membership from smaller industries or workplaces);

(d) Advocating with senior management of these workplaces to undertake sensitisation of workers;

(e) Since most of the workers in smaller industries or workplaces are temporary, there is much less commitment towards workers' welfare. An alternative plan is to contract Non-Governmental Organisations to run awareness

programmes for the workers (e.g. HIV & YOU model of United Nations Development Programme);

(f) Establish referral linkages with public and private sector providers for Sexually Transmitted Infection,

Integrated Counselling and Testing Centre, care, and treatment services.

Linking programmes in destination and source State AIDS Control Society

A Memorandum of Understanding between State AIDS Control Society provides a perfect structure for the pooling of information and resources. This is beneficial to both states and helps reach those at most risk at both source and destination, for example, in migrants and their sexual partners in the destination State, and returning migrants and their sexual partners in the source State. The data of migrant mapping at the destinations will also provide information on the migrants' source States or regions or Districts or Blocks. This information should be shared with the source State to facilitate outreach to returning migrants and to their spouses or sexual partners back home. At the same time, Outreach Workers who speak the migrants' own language and dialects may be provided to the destination States from the source State (through State AIDS Control Society orNon-Governmental Organisations). Further advantages of this strategy include:

(a) A linked programme enables a holistic approach that includes both migrant and spouse or sexual partner and the extra marital relationships of both. Outreach to migrant spouses can be done through the ongoing HIV prevention and care programmes in the source state by engaging link workers and community based structures;

(b) Linked programming provides a framework for understanding the complete context within which migration operates: the push factors of out migration, the cycle of leaving and returning, the flow of funds, sexual networking at destination and source, and the living and working environment of migrants at destination. Linked programming provides vital and powerful information with regard to the nature of HIV risk and vulnerabilities in both destination and source States;

(c) Facilitating assessment of impact of migrant interventions: Since migrant interventions under National AIDS Control Programme III are designed and executed at destination locations, source states can collect and provide information to monitor and evaluate the degree of success of these interventions (particularly on health seeking behaviours, condom use by returning migrants with spouses or sexual partners at home and some of the proxy indicators of reduced vulnerability of migrants going out). Again, this will be done through the ongoing HIV prevention and care programmes in the source State by engaging link workers and community based structures;

(d) Integrate HIV into ongoing work of Non-Governmental Organisations: Integrating HIV interventions into the ongoing work of Non-Governmental Organisations rather than having stand alone initiatives can be an effective strategy to address issues of basic human rights, including the rights of migrants or workers at destination and issues of stigma and discrimination. In addition, establishing links with other government programmes that benefit migrants in both source and destination States can facilitate the realisation of their rights and entitlements, reduce their vulnerabilities and improve their overall quality of life;

(e) Communication material sharing: A linked programme provides the cultural affinity that is necessary for providing support to "strangers in a strange land". For example, Information, Education and Communication or Behaviour Change Communication materials in the migrant's home language can easily be obtained from the source States.

Engage industry or workplace institutions, employers' associations, other allied organisations

and structures

These stakeholders should be engaged to develop and implement policies that reduce the vulnerability of migrants and promote accessibility of services. They could follow the same guidelines for a workplace policy as described in Paragraph 2.2.2.B. Key responsibilities at this level include:

(a) Development of healthy workplace policies for migrants that reduce their vulnerability to HIV;

(b) Incorporation of education programmes for migrant labourers at an early stage of induction into the industry to

provide them with perspectives, information and skills to reduce their HIV related vulnerability and risk.

C. Non-Governmental Organisations and other implementers (including workplace Non-

Governmental Organisations)

(a) Identification of migrant pockets;

(b) Being part of State AIDS Control Society programme;

(c) Hiring of project staff;1996 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] (d) Mainstreaming activities;

(e) Monitoring of projects;

(f) Community development and empowerment;

(g) Local advocacy programme.

D. Other government departments

(a) Sharing information and knowledge on migrant population;

(b) Integration of HIV or AIDS programme in ongoing interventions.

E. Core group targeted intervention partners

(a) Working with sexual partners of migrant population

(b) Coordination with Non-Governmental Organisation implementing programme and Social Marketing Organisation

F. Social marketing organisations

(a) Coordination with migrant Targeted Intervention implementing partners;

(b) Provision of condom supply and chain management for Targeted Intervention;

(c) Capacity building of Non-Governmental Organisation project staff and Volunteer Peer Leaders in condom promotion.

G. Other development agencies

(a) Mainstreaming HIV or AIDS through network based approach;

(b) Meeting other needs of migrant population through resource provision;

(c) Coordination with Non-Governmental Organisation implementing Targeted Intervention project; (d) Sharing knowledge, resources and skills for community development.

H. Summary table

The following table summarises the overall role of each agency in setting up migrant Targeted Interventions:

Refer also to Section11 ("Who will do what?") of Non-Governmental Organisation or Community Based Organisation Guidelines, National AIDS Control Organisation, March 2007.

Tools

Annexure 8Model HIV or AIDS Workplace Policies

National AIDS Control Organisation Non-Governmental Organisation or Community Based

Organisation Guidelines

2.2.3 Capacity Building

Capacity building inputs at all levels of implementation, i.e. State AIDS Control Society, Non-Governmental Organisations and industrial centres or workplaces, other government departments, service providers, project staff and Volunteer Peer Leaders should be planned for effective Targeted Interventions for migrant population. The capacity building inputs should include:

(a) Training;  (b) Exposure visits;  (c) "Handholding" or mentoring; (d) Knowledge and experience sharing workshops.





A. Linkages with other HIV programmes

In addition to HIV specific technical areas, project staff should acquire more general skills enabling them to implement and manage interventions, such as conducting assessments, project planning, budgeting, Monitoring and Evaluation.

Different departments within State AIDS Control Society should work in coordination with each other. In the rapidly changing environment of HIV, their training requirements may vary. These may include the following issues:

(a) Structures, policies and procedures;  (b) Good governance, management and decision making;  (c) Management information systems and institutional learning;  (d) Critical analysis and strategic thinking;  (e) Human and financial management systems;  (f) External relations and partnership building;  (g) Resource mobilisation.

B. Capacity building approaches Conventional and non conventional capacity building approaches should be encouraged at all levels. . At State AIDS Control Society level

(a) Capacity building needs assessment for the State;

(b) Generation of capacity building resource pool of institutions and individuals;

(c) Development of training modules;

(d) Establishment of a regular capacity building input monitoring system;

(e) Interstate 

(f) Memorandum of Understandings and sharing of knowledge and resources.

At implementing agency level

(a) Regular training programmes for mainstreaming HIV or AIDS intervention in other developmental programmes;

(b) Community development training programmes and activities.

CHAPTER 3

Implementing Targeted Interventions for Migrants:

Guidelines for Non-Governmental Organisations

TABLE OF CONTENTS

3.1 STEPS IN IMPLEMENTATION

3.1.1 Step 1: Stakeholder Analysis

A. Objectives

B. Defining stakeholders in migrant interventions

Primary stakeholders (target population) Secondary stakeholders Tertiary

stakeholders

C. Location of stakeholders

Prioritised industrial or workplace centres

Residential area of migrants

Hotspots

Cross cutting stakeholders

D. When to do it?

E. Who will do it?

F. Steps in Stakeholder Analysis

Importance vs. influence

Participation matrix

3.1.2 Step 2: Peer Education

A. Role of the Volunteer Peer Leader

B. Selection criteria for Volunteer Peer Leaders

C. Identifying potential of Volunteer Peer Leaders

D. Capacity building strategy for Volunteer Peer Leaders

Materials required by Volunteer Peer Leaders

E. Sustainability of the Peer Education Programme

F. Recognition for Volunteer Peer Leaders

3.1.3 Step 3: Behaviour Change Communication

A. Mid media

B. Interpersonal Communication

Contact strategy for Interpersonal Communication

Development of Behaviour Change Communication and Information, Education and

Communication materials

3.1.4 Step 4: Sexually Transmitted Infection Management

A. Planning for Sexually Transmitted Infection services

B. Referral services for other illnesses

C. Social marketing of Sexually Transmitted Infection services

3.1.5 Step 5: Condom Programming

A. Monitoring condom availability

B. Condom boxes

3.1.6 Step 6: Community Mobilisation – Safe Spaces for Migrants

3.1.7 Step 7: Creating an Enabling Environment

3.2 Programme Management

3.2.1 Service Package

3.2.2 Operational Strategy and Implementation Plan

3.2.3 Monitoring and Evaluation

A. Monitoring indicators

B. Evaluation indicators[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2001

3.1 STEPS IN IMPLEMENTATION

3.1.1 Step 1: Stakeholder Analysis Stakeholder Analysis is the identification of a project's stakeholders and the assessment of their interests and the ways in which these interests affect the programme's risk and viability. It is conducted as part of an overall needs assessment (and the overall process is hence often referred to by the acronym NASHA). The Stakeholder Analysis:

(a) Identifies ways of harnessing the support of those in favour of the intervention;

(b) Manages the risks posed by stakeholders who oppose the intervention;

(c) Identifies the specific role that a particular stakeholder can play to achieve the intervention's.

objectives.

A. Objectives

The overall objective of Stakeholder Analysis is to ensure the participation of stakeholders at various levels of the intervention for reaching the desired project impact and sustaining the desired changes. Stakeholder Analysis has the dual benefit of interaction and rapport building with the community when collecting information, while at the same time contributing to partnership in programme implementation.

More specifically, an Stakeholder Analysis will help to:

(a) Identify and draw out the interests of stakeholders in relation to the issues the programme is seeking to address;

(b) Capture local behaviours and perceptions within the intervention site that will allow more accurate and effective communication activities to be designed;

(c) Identify conflicts of interests between stakeholders which will influence the impact of the project and manage these in such a way that maximum positive involvement is achieved from various stakeholders;

(d) Identify relations between stakeholders which can be built upon, and enable strategic alliances of sponsorship, ownership and cooperation;

(e) Help to assess the appropriate type and role of participation by different stakeholders at successive stages of the project cycle;

(f) Identify the underlying causes of poor health among the target group and develop strategies in a participatory way to address them;

(g) Develop an enabling environment to sustain the desired positive behaviour changes introduced by the programme;

(h) Identify and promote the formation of community stakeholder groups and potential Volunteer Peer Leaders.2002 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] The place of Stakeholder Analysis within the context of mapping and planning is seen in Figure 3.1.

NEEDS ASSESSMENT TARGETED INTERVENTION

AREA

AREA

PROFILE

GROUPS WITH

SOCIAL

ANALYSIS OR

ECONOMIC HIGH RISK

ANALYSIS OR BEHAVIOUR

DEMO GRAPHIC ANALYSIS

BEHAVIOUR CHANGE COMMUNICATION

BEHAVIOUR ANALYSIS

CONDOM DATA ANALYSIS

SAFER SEX

&CONDOM

USAGE

Sexually

Transmitted

Infection

TREATMENT

Sexually

Transmitted

Infection

DATA

ANALYSIS

BEHAVIOURDET

ERMINANTS

STAKEHOLDER

ANALYSIS

ENABLING

ENVIRONMENT

Figure 3.1 Relationship between Needs Assessment or Stakeholder Analysis and Targeted

Intervention

B. Defining stakeholders in migrant interventions

Primary stakeholders (target population)

Placement agencies, brokers, dalals

(a) High risk migrant men and women who are interact with or are part of high risk sexual networks (Female Sex Workers, Men Who Have Sex with Men orTransgenders);

who "source" migrants and supply them to (b) Spouses or sexual partners of migrants; (c) Migrants living with and affected by HIV and AIDS.

contractors form one of the main sets of

stakeholders for migrant interventions.

Secondary stakeholders (a) Placement agencies, brokers and others;

Stakeholder Analysiss should clearly identify, (b) Families of high risk migrant men and women;

and advocate with, this critical power structure.

(c) Families of migrants living with and affected by HIV and

AIDS;

(d) Sexual network operators (Female Sex Workers, Men Who Have Sex with Men or Transgenders) and power structures;

(e) Health care providers (government and private, qualified, unqualified);

(f) Non-Governmental Organisations, Community Based Organisations and other agencies implementing Tis;

(g) Workers associations, employees unions, trade unions;

(h) Infected and affected migrants, People Living with AIDS networks.

Tertiary stakeholders

(a) Industrial centres, informal workplace institutions, employers associations, other allied organisations and

structures;

(b) Community level voluntary structures, e.g. migrants and youth forums or clubs, mandals, safe spaces or drop in

centres for migrants (Spaces for Migrants);

(c) Decision makers in the community, i.e. social and political leaders, police, elected representatives (Panchayati Raj

Institutions), development functionaries;

(d) Non-Governmental Organisations, Community Based Organisations, CSOs;



(e) State AIDS Control Society in both source and destination states;



(f) National AIDS Control Organisation and the donor agencies.

C. Location of stakeholders

A separate needs assessment and Stakeholder Analysis has been envisaged for each type of intervention area (prioritised industrial or workplace locations, large residential locations and hot spots) for undertaking Targeted Interventions with high risk migrants. This exercise will yield relevant stakeholders, and depending upon the role they might play, an appropriate strategy for their involvement may be designed.

Prioritised industrial or workplace centres

Working with the owners and social welfare officers of industrial or workplace centres is essential to create an enabling environment for successful implementation of the project. Many such industrial or workplace centres engage various contractors for labour and raw material supply, and these also form an important category of stakeholder as they have greater influence on the migrant population. There may be canteens and dhabas in and around the workplaces, and their owners can be tapped to reach out to the target population. Similarly, security agencies employed by the workplaces could emerge as another stakeholder.

Residential areas of migrants Some areas in the place of destination are obvious and well known living places for migrants, e.g. slums and temporary

shelters. A transect walk in these areas and conducting the Needs Assessment Stakeholder Analysis will help to locate

influential stakeholders such as kabadi shops, tea stalls and cigarette shops that can be involved in reaching out to the

target population. Often, unqualified private practitioners whom residents of slums and temporary settlements visit for their

day to day medical needs will be identified as key stakeholders.

Hotspots Sometimes there are known hotspots where migrants congregate (e.g. sex worker hotspots, cinema halls). These can be

useful areas to identify possible methods of intervention (e.g. mid media activities).

Cross cutting stakeholders

Apart from separate stakeholders specific to each intervention site, there may be some "cross­cutting" stakeholders whose

interests are not bound to a specific location. These include unions to which migrant populations are attached and without

whose help and support they often do not get jobs at the place of destination. Examples include riksha pullers unions, auto

drivers associations and traders associations (particularly in vegetable and grain mandis, etc.).

D. When to do it? Stakeholder Analysis is a part of the needs assessment exercise. Once the area of intervention has been finalised the

needs assessment and Stakeholder Analysis will be conducted in turn. "Social sanction activities" are helpful to establish an

initial rapport with the community before Stakeholder Analysis is conducted, for example by organising mid media activities

in the intervention areas.

Stakeholder Analysis involves participatory techniques such as social mapping, focus group discussion, in depth interviews

or Key Informant interviews. See Annexure 9,Information Collection in Stakeholder Analysis.

E. Who will do it? Outreach Workers and senior staff of the Non-Governmental Organisation along with some key stakeholders carry out the Stakeholder Analysis.

It is important to note that the information or data collected by various needs assessment exercises like focus group

discussions, in depth interviews, Key Informant interviews, transect walks will form the basis of the Stakeholder Analysis.

Since it is impossible to gather all stakeholders together, these groups should be met with separately in the initial stage of the project. Through the Stakeholder Analysis, clarity about the various stakeholders' roles in the project cycle will help to ensure support based on mutually agreed expectations. Conflicting parties must know that the project objectives are the binding force for meeting and interaction among stakeholders. A clear and transparent process will ensure that a heterogeneous group of stakeholders gradually coalesces towards a common goal.

F. Steps in Stakeholder Analysis

(a) Draw up a "stakeholders table";  (b) Identify stakeholders' interests in the project and rank them according to their importance to the project's success;  (c) Assess stakeholders' relative influence over the beneficiaries;  (d) Conduct a comparative analysis between stakeholders' importance and influence;  (e) Plan their involvement in project cycle accordingly;  (f) Share the analysis with key stakeholders.

Importance vs. influence

Importance is distinct from influence. For example, there will be stakeholders, especially unorganised primary stakeholders, upon whom the project places great importance. However, these stakeholders may have limited capacity to influence key decisions. By considering influence and importance, stakeholders can be classified into different groups, which will help identify the assumptions and risks which need to be managed through project design.

 I        High           High
M         Importance     Importance
P         Low            High
O         Influence      Influence
R         (A)            (B)
T         Low

                         Low
A
         Importance      Importance
N        Low             High
C        Influence       Influence
E        (D)             (C)

INFLUENCE

Box A: Stakeholders of high importance to the intervention, but with low influence. They require special initiatives if their interests are to be protected.

Box B: Stakeholders of high importance to the intervention who can also significantly influence its success. Managers and donors will need to develop good working relationships with these stakeholders to ensure an effective coalition of support for the intervention.

Box C: Stakeholders with high influence, who can affect outcome of the intervention, but whose interests are not the target of the intervention. These stakeholders may be able to block the intervention and therefore require careful management.

Box D: Stakeholders who are of low priority but may need limited monitoring. They are unlikely to be the focus of the intervention.

Those included in Boxes A, B and C are the key stakeholders in the intervention: they can significantly influence it or are most important to the intervention's objectives.

Participation matrix

The next step is to plan the extent and nature of the participation of stakeholders in different stages of the intervention (from being informed about the intervention to being an active participant or a partner). A discussion with stakeholders based on the findings of the influence­importance matrix leads to a "participation matrix" to identify appropriate stakeholder participation.

An example of a participation matrix is provided below to illustrate this point. In this matrix, certain stakeholders have been ranked on importance and influence on a scale of 1 to 5, with 1 being the least important or influential and 5 being the most.

Tool

Annexure 9 Information Collection in Stakeholder Analysis

3.1.2 Step 2: Peer Education

Communication as the main mode of communication, mid media is the core method of peer education for migrants (as also with truckers).

Peer education is one of the most widely used strategies to address the HIV or AIDS pandemic. A peer is one of equal standing with another, one belonging to the same societal group especially based on age, grade or status. The purpose of Volunteer Peer Leaders is to ensure that High Risk Groups are reached and information on Sexually Transmitted Infections and HIV or AIDS is shared with them to bring out a positive behaviour change. For Targeted Interventions to migrants, Volunteer Peer Leaders are envisaged as volunteers from the migrant community.

Peer involvement is an effective way of reaching communities and affecting change in community norms. Volunteer Peer Leaders are knowledgeable "insiders" in migrant settings, and their involvement enhances trust and communication. Volunteer Peer Leaders are consequently a credible source of advice. They can be powerful role models and can help to change social norms. Volunteer Peer Leaders also act as a link between migrant workers and Targeted Interventions, facilitating local participation. Peer networking and the sharing of information often leads to community mobilisation around issues of concern.

A. Role of the Volunteer Peer Leader

Volunteer Peer Leaders are a link between project and migrant workers. Their main responsibilities are:

(i) Operational elements : 

(a) Undertake risk assessment of migrant population in their area of operation based on criteriaof multi partner sex and history of Sexually Transmitted Infection status, and identify at risk individuals for the purposes of the Targeted Intervention. This can be done through one to one contacts. Volunteer Peer Leaders also need to identify those migrants who overlap with high risk sex networks (either as sex workers or clients of sex workers); (b) Link migrant workers with project services such as condoms, counselling and referral services,e.g. testing, care and support, etc; (c) Collect data related to the project for planning;  (d) Support condom promotion activities undertaken by Non-Governmental Organisation staff and or other organisations engaged for mid media campaign for condom promotion;  (e) Mobilise the target group to participate in mid media campaign activities, e.g. street plays, videoshows, slide shows, infotainment, health camps, mobile exhibition, World AIDS Day programmes, etc. conducted by Non- Governmental Organisation staff;

(ii) Behaviour Change Communication : 

(a) Sharing information related to HIV or AIDS and safer sex practices with those migrants who are at risk of HIV;

(b) Use of Behaviour Change Communication materials for effective Interpersonal Communication to address myths and misconception regarding HIV or AIDS;

(c) Motivate and dialogue with migrants who are at risk to adopt safer sexual practices;

(d) Education on condom usage: buying, storing, opening, using, and disposing;

(e) Encourage migrants to maintain cleanliness and personal hygiene.

(iii) Sexually Transmitted Infections:

    (a)    Create  awareness  among  the  migrant  population  of  common  symptoms  of  Sexually  Transmitted
           Infections and the need to seek appropriate treatment from qualified practitioners;
    (b)    Support migrant workers in accessing Sexually Transmitted Infection treatment services (project run or
           referral services);
    (c)    Remove myths and misconceptions related to Sexually Transmitted Infection;
    (d)    Follow up Sexually Transmitted Infection patients and their partners wherever possible for treatment
           compliance;
    (e)    Mobilise migrants for health camps and related events in the areas;
    (f)    Provide referral slips or cards.
(iv)  Care and support:
    (a)    Identify and support People Living with AIDS in the migrant workers area;
    (b)    Help them to access treatment;
    (c)    Link to other departments to provide psycho social support.
(v)   Advocacy:
    (a)    Meet  with  community  leaders  identified  through  the  Stakeholder  Analysis  and  stakeholders  for
           sensitisation on HIV or AIDS and project activities;
    (b)    Facilitate community resources for the project.
(vi)  Linkages with HIV and other services:
    (a)    Linkages with Antiretroviral Therapy centre;
    (b)    Identification  of  early  symptoms  of  Tuberculosis  and  referral  to  Directly  Observed  Treatment  Short-
           Course Chemotherapy;
    (c)    Help them to access testing and Integrated Counselling and Testing Centres.



B. Selection criteria for Volunteer Peer Leaders

Following are key considerations for PE selection:

(a) Must be of the same ethnic group as the migrant population;

(b) Willing to work for the community on a volunteer basis;

(c) Demonstrate self confidence and show potential for leadership;

(d) Good listening, communication, and interpersonal skills;

(e) Understanding of the cause and committed to the goals of the project;

(f) Knowledge of problems and difficulties of the community;

(g) Should be acceptable among the target audience with whom they will work.

C. Identifying potential of Volunteer Peer Leaders

Based on some of the considerations above, the identification of context specific Volunteer Peer Leaders for migrant Targeted Interventions may proceed using the following list of examples:

(a) Petty shop owners in and around the area where migrants work, congregate or reside, e.g. mechanic shop owner, owners of small hotels which provide lunch and dinner for the target population, owners of popular tea shops, paan and cigarette shopkeepers, etc.;

(b) Members of various associations of migrant workers, e.g. riksha puller association, auto drivers association, supervisors of those working as labourers at various mandis;

(c) Contractors who supply labourers for skilled or unskilled work, including construction;

(d) Social welfare officers of workplaces which employ migrant workers on a casual basis;2008 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] The identification of Volunteer Peer Leaders should be initiated as part of project activities such as the Needs

Assessment and Stakeholder Analysis and determining individual migrants who are at most risk.

D. Capacity building strategy for Volunteer Peer Leaders Working as a PE requires special skills, and it is important to build capacity on technical as well as operational aspects of the project activities.

Capacity Building Structure

(a) Initial structured sessions (b) Periodic refresher sessions (c) Supervision (d) Ongoing interaction and support for problem solving

A cascade training approach is envisaged for building capacity of Volunteer Peer Leaders. A cadre of "Master Trainers" will be developed by State AIDS Control Society for overall support of migrant Targeted Interventions in the State and Districts. The main responsibility of these Master Trainers is to train the Non-Governmental Organisation staff on:

(a) The basics of HIV or AIDS (b) Conducting needs assessment and Stakeholder Analysis (c) Project operational plans (d) Approaches and methods of selection of Volunteer Peer Leaders (e) Organising capacity building sessions for Volunteer Peer Leaders

The trained staff of the Non-Governmental Organisation, supported by the Master Trainers, will conduct a two day structured training programme for the Volunteer Peer Leaders. Once the Volunteer Peer Leaders are trained on technical and operational aspects of the project elements, Non-Governmental Organisation staff will be in touch with them during regular field visits. A monthly capacity building cum review meeting can be organised with Volunteer Peer Leaders by the Non- Governmental Organisation staff to help solve any operational problems, discuss field activities and provide necessary support.

To maintain the motivation level of the Volunteer Peer Leaders, the Non-Governmental Organisation should organise quarterly one day structured refresher programmes. The operational support and handholding of Volunteer Peer Leaders will help sustain their motivational level, facilitate field level problem solving and encourage their participation in project activities. The capacity building strategy should follow the following framework:

Volunteer Peer Leaders may initially face hostility from the community they seek to serve. Working in groups provides support and strength in numbers. In order to be effective, Volunteer Peer Leaders need to be seen and heard regularly.

Materials required by Volunteer Peer Leaders (a) Flip book

(b) Hand bills

(c) Penis model[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2009 (d) Condoms

(e) Sexually Transmitted Infection Flip book

(f) Referral Cards

(g) Daily Diary

(h) Bag or Cap or Badges

E. Sustainability of the peer education programme Intentional strategies must be followed to make the peer education programme viable throughout the time of the Targeted

Intervention and beyond. These include:

(a) Develop a cadre of motivated Volunteer Peer Leaders and encourage them throughout the project period; (b) Initiate federation or networking or group formation of Volunteer Peer Leaders at local level at the later stages of the project implementation. After establishing the Targeted Intervention and "handholding" for some time, an attempt should be made to form a Community Based Organisation of Volunteer Peer Leaders, in order to sustain project activities into the future. Other approaches to organising Volunteer Peer Leaders in formal or informal groups may be attempted depending upon the context and with active participation from the Volunteer Peer Leaders;

(c) Institutionalise recognition systems and establish mechanism for regular interactions among Volunteer Peer Leaders as well as between Volunteer Peer Leaders and key stakeholders, including government counterparts. F. Recognition for Volunteer Peer Leaders Volunteer Peer Leaders are expected to work with the project on a voluntary basis, and to continue as a volunteer withthe same activities beyond the project life span. To maintain their motivation to carry out stipulated tasks on a voluntary basis even with the project's time frame, a recognition and reward system should be devised by the project. While this system may vary in different contexts, it is essential in order to keep Volunteer Peer Leaders engaged in project activities. The recognition and reward system should accomplish two objectives:

(a) Reward superior performers and recognise outstanding accomplishments based on specific, measurable and

transparent criteria

(b) Make the status of a peer with the programme aspirational for the target group

Examples of recognition and reward activities include: (a) Monthly meetings for Volunteer Peer Leaders to learn from one another;

(b) Follow up refresher training;

(c) Maintaining continued periodic interactions in the field;

(d) Providing extra or enhanced materials to facilitate Volunteer Peer Leaders' work, e.g. diary, reference materials, flip books, posters, handbills, stickers, etc.;

 (e) Exposure visits to various similar Tis;

(f) Developing a healthy competitive attitude among Volunteer Peer Leaders;

(g) "Peer of the Month" award;

(h) Certificates or badges for good performance;

(i) Gifts and recognition awarded by celebrities.

3.1.3 Step 3: Behaviour Change Communication The aim of Behaviour Change Communication is to make individuals perceive, understand and accept their self risk due to specific behaviours and to create a desire for preventive action.

A Behaviour Change Communication plan for migrants should be based on the following considerations:

(a) What are the barriers to adoption of safe behaviours or factors that encourage adoption of unsafe behaviours? (b) What are the factors that can be used to motivate change in behaviour?

(c) What are the most appropriate timings and venues for Behaviour Change Communication (mid media and Interpersonal Communication)?

(d) What types of Information, Education and Communication and Behaviour Change Communication material are most appropriate as communication tool?2010 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] (e) What is the mix of languages within the community?

Behaviour Change Communication for migrant Targeted Interventions has two primary components: mid media and Interpersonal Communication.

A. Mid media

Mid media is a creative and efficient way of generating awareness on certain key issues among large numbers of people. Interactive mid media techniques, such as street theatre in which the audience is invited to comment on a dramatic situation, can be used to provoke a discussion on community norms. Examples of mid media include:

(a) Street theatre

(b) Games

(c) Traditional local media (interactive street theatre, e.g. Bhavai, Ramlila, etc.)

(d) Exhibitions

(e) Information, Education and Communication campaigns

(f) Debates and discussions

(g) Audio or video or film shows

(h) Special observances and commemorations (e.g. World AIDS Day)

(i) Information kiosks (displays of poster and relevant materials with provision of one to one counselling)

A professional agency may be engaged to conduct many of the mid media events (e.g. street theatre performances), but some activities can be conducted by Non-Governmental Organisation staff on a regular basis (e.g. film shows, information kiosks).

B. Interpersonal Communication Mid media can be supplemented by one to one Interpersonal Communication focused on those individuals who are in need of greater information. One to one Interpersonal Communication can be delivered immediately after thought provoking mid media to that sub set of the audience that stays back to obtain more information or seek services. In the interest of maximising efficiency, it is important to identify that sub group of migrants with high risk behaviour (primarily single migrant workers) who need to be provided additional information through one to one interaction. One to one interaction can focus on:

(a) Information on HIV or AIDS, means of transmission, prevention, Sexually Transmitted Infections, etc.

(b) Risk perception of individual

(c) Understanding of high risk behaviour and its consequences

(d) Options for safe behaviours

(e) Information on access to condoms and services available in the area for Sexually Transmitted Infection treatment, HIV testing and counselling



Contact strategy for Interpersonal Communication

The ratio of Volunteer Peer Leaders to migrants is 1:100. Within this population of migrants, the PE should identify high risk individuals with the help of Outreach Workers from the Non-Governmental Organisation. High risk migrants should be met with once a week in the initial stages of the project, though the frequency may be modified depending upon the behaviour of the individual migrants (see Annexure 1).

The Non-Governmental Organisation should prepare a detailed Behaviour Change Communication strategy with a conversation plan for Volunteer Peer Leaders identifying a series of topics for discussion, e.g. safe sex methods, correct method of condom use, myths around condom use, partner notification for Sexually Transmitted Infections, etc. It is important to note that while a minimum package should be designed to ensure a basic level of information and services for entire community, peer communication in the field should not be limited to these topics. Peers should be skilled enough to draw on their knowledge and tailor a discussion to the needs and concerns of specific individuals.

Development of Behaviour Change Communication and Information, Education and

Communication materials

Information, Education and Communication and Behaviour Change Communication material should be developed based on the needs of the community. Existing job aids or migrant specific Behaviour Change Communication materials in the form of flipcharts, case studies and story based flashcards can be adapted for use by Volunteer Peer Leaders. It is important to use images and situations with which the migrant population can identify. Often there will be a need for material in more than[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2011 one language within one project. The language mix should be based on the profile of the migrant community (as indicated by the initial mapping and Needs Assessment Stakeholder Analysis exercises).

The Behaviour Change Communication material should be developed and adapted in a participatory way by conducting pre testing protocols after considering regional, cultural and target group characteristics.

3.1.4 Step 4: Sexually Transmitted Infection Management

Targeted Interventions for migrants will focus on four aspects of Sexually Transmitted Infection prevention and management: (a) Activities to generate awareness of Sexually Transmitted Infection symptoms while emphasising the long term

consequences of such infections, the need for correct and complete treatment, and the means of prevention

(b) Establishment of a referral network for treatment by interacting with existing health care providers, both public as well as private health facilities as mapped in and around the project site, including training on syndromic case management

for providers (c) Follow up and tracking to improve treatment seeking and compliance with treatment. Volunteer Peer Leaders and Outreach Workers may use referral slips to monitor whether clients have followed up on referrals (see

Annexure10, Referral Slip). (d) Ensuring condom availability

The Sexually Transmitted Infection services to be provided are:

(a) Health promotion and Sexually Transmitted Infection prevention activities, such as promoting correct and consistent use of condoms (b) Provision of condoms  (c) Immediate diagnosis and clinical management of Sexually Transmitted Infections using syndromic case management  (d) Health education and counselling for treatment compliance, correct and consistent use of condoms and regular partner treatment (e) Partner management programmes (i.e. contact referral)  (f) Follow up services  (g) Counselling for HIV positive persons (h) Referral links to Integrated Counselling and Testing Centre, HIV care and support and other relevant services.

A. Planning for Sexually Transmitted Infection services

The needs assessment undertaken at the start of the project should generate data on the following:

(a) Information on current barriers to accessing Sexually Transmitted Infection services  (b) Ways in which Sexually Transmitted Infection services can be made accessible and acceptable to the community in terms of location, operating hours, etc. (c) Context specific preferred list of physicians

Once this information has been gathered, the Non-Governmental Organisation must network with the identified service

delivery providers to establish dependable services and to orient staff on syndromic case management and treatment of

In addition to these technical or medical considerations, special attention should be paid to ensuring that Sexually Transmitted Infection service delivery options are community friendly. This means:

(a) Clinicians with a supportive attitude towards the community

(b) Availability of services as per the needs of the community, e.g. late night access

(c) Access to services at optimal location (e.g. not too far from major sex work sites, not requiring outlay for public transport)

(d) Basic infrastructure of facility as per National AIDS Control Organisation Sexually Transmitted Infection guidelines

(e) Confidentiality between the clinic team and the community

B. Referral services for other illnesses The project should actively create referral linkages for other health concerns of migrants. Again, such linkages can draw on both government facilities as well as qualified private practitioners.

C. Social marketing of Sexually Transmitted Infection services

Health services and drugs for migrants should be socially marketed, as opposed to free of cost, for the

following reasons:

(a) Migrants have disposable income and therefore can afford to pay socially marketed rates for such

services

(b) Such services are valued more by the community when they are provided at a nominal fee

(c) Services are perceived to be of higher quality when provided at a nominal charge

(d) This is more sustainable than providing services free of cost. Private practitioners can more easily be

engaged by the programme on a social marketing model

Tool

Annexure 10 Referral Slip

3.1.5 Step 5: Condom Programming

Condom promotion in migrant Targeted Interventions entails:

1. Regular demand generation activities to increase visibility, perception of accessibility and demand for condoms

2. Ensuring availability of an adequate supply of socially marketed condoms at traditional and non traditional condom outlets in and around the project sites

3. Condom demonstrations by Volunteer Peer Leaders and Outreach Workers to ensure correct usage of condoms.

A Social Marketing Organisation should be contracted for activities (1) and (2) above. The project should undertake training and capacity building of Volunteer Peer Leaders and Outreach Workers to build their knowledge of the benefits of condom use and to impart skills in conducting condom demonstrations and addressing common misconceptions surrounding condoms (reduced pleasure, breakage, etc.).

A. Monitoring condom availability Volunteer Peer Leaders and Outreach Workers should also be encouraged to solicit feedback on the availability of condoms, preferred brands, etc. This information should be provided to the Social Marketing Organisation to improve distribution. Condom availability at the intervention location should be assessed according to the following:

(a) Number of outlets carrying condoms: Focus should be on those outlets that are convenient for migrants, e.g. those open at night. It is necessary to monitor distribution in traditional and non traditional outlets. Non traditional outlets are those that are not retail outlets (e.g., bars, dhabas, barbers, etc.). Such outlets are often more convenient and accessible for migrants.[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2013 (b) Visibility of condoms at these outlets: Merchandising at outlets (i.e. prominent display of condoms, posters, banners, etc.) helps increase demand for condoms. Often merchandising material triggers recall of a message and prompts a purchase.

B. Condom boxes

In corporate sponsored workplace interventions, condom boxes may be provided at the site. Condom boxes enable workers to access condoms anonymously and free of cost. They should be installed at accessible and relatively private locations (e.g. toilets). Volunteer Peer Leaders can be charged with ensuring that adequate supplies are available through condom boxes.

3.1.6 Step 6: Community Mobilisation – Safe Spaces for Migrants

Community mobilisation entails creating a platform for the community to come together to discuss common issues and social norms and to build a collective desire for preventive action. In order to create such a platform, the project should create "safe spaces" for migrants: (a) The concept of "Space for Migrants" takes into account the multiple needs of migrants, with a focus on building their social capital to reduce their vulnerability to HIV or AIDS

(b) State AIDS Control Society will contract Non-Governmental Organisations or migrant support organisations to establish Spaces for Migrants in partnership with the Urban Development Agency who work in slums and or private sector organisations (if possible)

(c) Space for migrants (like Drop In Centres for High Risk Groups) should be located by Non-Governmental Organisations through the following process:

(i) Identify existing congregation points for migrant workers. These may include places of entertainment like video parlours, bars, etc. In the case of a workplace intervention, a congregation point may be a common resting area or lunch room.

(ii) If an existing congregation point is not found to be appropriate, the project should create a new facility that can be used as a project centre

(d) Spaces for Migrants are managed by Volunteer Peer Leaders and provide the following services:

(i) Volunteer Peer Leaders to provide minimum information on HIV or AIDS and related subjects to migrant workers. Information could include awareness on HIV or AIDS prevention and care, combined in a creative way with information beyond HIV which addresses migrant needs (e.g. how to remit money home, banking options, social welfare services).

(ii) Information, Education and Communication material available for easy access by migrant workers

(iii) Socially marketed condoms

(iv) Referral to Integrated Counselling and Testing Centres and Sexually Transmitted Infection clinics

(v) Recreational material including radio, TV, games, magazines or newspapers, etc.

(vi) Activities aimed at reducing drug and alcohol related vulnerabilities

(vii) Outreach facilities including periodic health camps

3.1.7 Step 7: Creating an Enabling Environment

The process of the Stakeholder Analysis is an important component of creating an enabling environment for the Targeted Intervention. The Targeted Intervention should also have linkages with government departments in order to meet non HIV needs of the target population. To be effective, it is essential that the Targeted Intervention create an environment where as many needs of the migrant population as possible are met relating to their living conditions, human and workers rights, etc. Key government departments with whom enabling environment efforts in migrant Targeted Interventions should focus include:

(a) Health Department: To access other health services under urban and rural health programmes;

(b) Labour Department: For unionising and implementation of labour laws;

(c) Civil Services Department: For basic amenities related to water, electricity, drainage, etc. at the place of stay;

(d) Transportation Department: To develop support services for migrant populations and link them with their families in their source states;

(e) Industry Department: To advocate for compliance with codes of conduct for HIV or AIDS.

3.2 PROGRAMME MANAGEMENT

3.2.1 Service Package

3.2.2 Operational Strategy and Implementation Plan The following table lists the suggested activities for establishing an effective Targeted Intervention for migrants and identifies those who are responsible for conducting each activity, as well as the timeline. Such detailed activity planning could be prepared separately for each type of intervention site (hot spots, prioritised industry or workplace locations and residential locations). Separate implementation plans will indicate specific activities and relevant stakeholders.

3.2.3 Monitoring and Evaluation Monitoring and Evaluation of Targeted Interventions for migrants is an essential and integral part of the overall project design. This section presents the overall framework for Monitoring and Evaluation, including specific indicators for monitoring the project activities and those which need to be collected as part of project evaluation.

A. Monitoring indicators: The principle applied here is to collect monitoring data which is most relevant for taking decisions at the field level; the information generated from the monitoring system is used to provide feedback to the project activities on a regular basis to take any needed corrective actions. Various indicators along with numerator and denominators for computing indicators and sources of information are outlined in the following table:

While the monitoring indicators described above will provide information about project status on a regular basis, evaluation of the Targeted Intervention is to be conducted at the end of the project period to determine the success of the Targeted Intervention in reducing migrants' vulnerability to acquiring HIV or AIDS.

Evaluation indicators are measurable parameters for each component and subcomponent of the Targeted Intervention with a verifiable source of information. The following table describes some of the relevant indicators for project evaluation purposes:

Tool

Annexure 11Ongoing Assessment of Volunteer Peer Leaders and Migrants

ANNEXURE 1

Risk Assessment

Objectives

A risk assessment seeks to ascertain whether male migrants in the potential intervention area are at risk by gathering the

following information:

(i) Demographic profile of the risk population;



(ii) Different types of partners among the risk population;



(iii) Proportion who have correct knowledge about the modes of HIV transmission;



(iv) Proportion who do not have any myths about the modes of HIV transmission;



(v) Condom related indicators;



(vi) Proportion who suffered from Sexually Transmitted Infections in last 12 months;



(vii) Proportion who sought treatment from a qualified practitioner for Sexually Transmitted Infections; 

(viii) Proportion who feel high risk with a female partner if they have sex in exchange for money or in kind; 

(ix) Proportion who feel it is important to know HIV status;



(x) Proportion who intend to get themselves tested.

Study Design:

Nature of the study:

Quantitative data collected through personal interviews with the help of a structured questionnaire

Target group

(i) Male

 

(ii) SEC C, D, E1



(iii) Aged 15 to 44 years

Sampling procedure:

(i) Electoral rolls can be used as sampling frame;



(ii) Up to 100 polling booths selected through systematic random sampling procedure;



(iii) In each polling booth area, 2 households identified through systematic random sampling procedure; 

(iv) In each household, 4 interviews conducted following the right hand rule.

Weighting procedure:

(a) Weighting is necessary to ensure that data correctly represents the overall situation in the intervention

area;

(b) The weighting procedure adopted is detailed below: 

(i) List total number of males in the household. Weight all males aged 18+ to the male voter

population;

(ii) From this is derived the total population of those aged between 18 44 years;

(iii) Assuming that those aged 15 to 17 years are similar in number to those aged 18 20, the

universe of those aged 15 44 can be derived;

(iv) For each male there is data at household level (bachelor or family households and SEC) and at individual level (age, education and marital status). Of these data, the most critical type is household and age;

(v) Hence for each of the cells of age X type of household the universal figures can be derived;

(vi) These weights are then applied to the individual section of responses.

Definition of Those at Risk:

In last 12 months fell into any one of the categories below one or more times:

(a) Had sexual intercourse;

(i) With female partner in exchange for money; (ii) With female partner in exchange for kind.

(b) Had sexual intercourse with male partner in exchange for money;

(c) Had sexual intercourse with eunuch in exchange for money.

ANNEXURE 2

Mapping Methodology

Preliminary and detailed mapping studies provide information on the presence of migrant workers who engage in high risk behavior, so as to accurately determine target group size and area coverage for effective field communication, two integral aspects of designing an evidence based Targeted Intervention.

PRELIMINARY MAPPING:

Objectives

A preliminary mapping study serves to acquire a geographic breakdown of the intervention area, as well as to gain insight into:

(a) The basic ethnic, religious and cultural background of its population;

(b) The various congregation points of high risk men;

(c) The presence of sex workers;

(d) The presence of various elements such as video parlours, mandals, Non-Governmental Organisations, temples, hotels, lodges, bars and movie theatres that could be vantage points for target efficient field communication.

The preliminary mapping provides a general overview of the entire geographic area, and is the basis to accurately refine

structured methods and tools needed to conduct a detailed mapping study.

Methodology:

Time period: 5 weeks

1. Outreach Workers are intensively trained on the methodology of conducting the study and familiarised with the mapping tool conducted in the area;

2. Outreach Workers are provided with a map of the intervention area;

3. Outreach Workers initially cover the entire area on foot or by vehicle to observe and gain preliminary insight into the geographic characteristics of the area, as well as to cursorily identify locations of the different elements;

4. In accordance with the map and their initial observations, Outreach Workers demarcate the area into distinct closed areas or clusters for convenience of coverage to conduct the preliminary mapping tool;

5. Subsequently, Outreach Workers visit each cluster, in which they;

6. Sketch the geographic location of the cluster;

7. Interview three Key Informants in each cluster utilising the mapping tool (ensuring three responses to each

question in the tool).

The Key Informants in each area include shopkeepers, cinema hall employees, slum residents, housing colony residents, slum development officers, Brihanmumbai Municipal Corporation officers, private doctors, government hospital doctors, Non-Governmental Organisations, industry employers and employees, bar owners and clientele, railway station masters and bus depot in charges.

DETAILED MAPPING

Objectives:

In order to ensure a target efficient, streamlined field intervention among migrant workers, a detailed mapping study is conducted, focusing on:

1. An assessment of the target group size of high risk men in the intervention location

2. Identification of target efficient hotspots or strategic locations for field communication

3. Identification of scope of coverage at existing hotspots

4. Determination of a possible range of field communication activities to be conducted at hotspots 5. An assessment of the presence of Commercial Sex Workers in the area and type of sex work conducted

Methodology:

Time period: Approximately one month to six weeks for each component

Outreach Workers are intensively trained on the methodology of conducting the study and familiarised with the different mapping tools conducted in the area, to ensure that they interview at least eight respondents in one day.

The detailed mapping tool is developed based on the observations of the Outreach Workers as well as the different responses of the Key Informants in the preliminary mapping study.

The detailed mapping has four primary components:

1. A detailed mapping tool to gain information on target group size as well as congregation points of high risk men (see Annexure 4);

2. A Commercial Sex Worker assessment to gain information on sites of sex work as hotspots for field communication activity (see Annexure 5);

3. A screening of hotspots, including mandals and video parlours, to gain information on high risk men and potential types and frequency of field communication activities (see Annexures 6and 7);

4. A drainage assessment to avoid overexposure or underexposure of the target group to field communication activities.

Component 1 – Assessment of Target Group Size and Congregation Points

1. Outreach Workers map each lane in the area and demarcate the geographic area into six clusters, based on the preliminary mapping as well as on more detailed observations on foot or by vehicle;

2. Each cluster is further divided into smaller pockets, based on local names of respective areas;

3. In each smaller pocket, Outreach Workers conduct detailed mapping using the tool with three Key Informants, to ensure that each question in the tool has three responses.

4. In each smaller pocket, Outreach Workers observe and identify the total number of structures (counting each structure in each lane), as well as the proportion of structures that house single men and those that house men in families;

5. In each smaller pocket, Outreach Workers interview three Key Informants to assess the number of men living in single men households and the number of men living in family households;

6. The target group size is calculated according to the following formula

7. (Average number of family men structures X Average number of men in family household) + (Average number of single men structures X Average number of men in single men household);

8. In each smaller pocket, Outreach Workers observe and identify the number of mandals, video parlours, sex work spots (including hotels, lodges and bars where sex work takes place), saloons, bhissis, daily labour job posting points as well as tea and paan stalls. Each element has a separate component in the detailed mapping questionnaire. In each pocket, for each element, Outreach Workers collect responses from three Key Informants, based on the questions in the detailed mapping tool.

9. In each smaller pocket, Outreach Workers observe and identify the number of congregation points of high risk men to ensure targeting efficiency with regard to field communication;

10. The Key Informants in each smaller pocket include shopkeepers, cinema hall employees, slum residents, housing colony residents, slum development officers, Brihanmumbai Municipal Corporation officers, private doctors, government hospital doctors, police, Non-Governmental Organisations, industry employers and employees, bar owners and clientele, railway station masters and bus depot in charges.

Component 2 – Commercial Sex Worker Assessment

1. In each smaller pocket, Outreach Workers interview three Key Informants to gain insight into the location of sex work spots, average rates charged by Commercial Sex Workers for sexual encounters, types of sex work in the area, the manner in which clients approach Commercial Sex Workers, and work timings of Commercial Sex Workers.

2. The assessment can provide insight into whether male residents visit Commercial Sex Workers within the target area or frequent red light areas outside the target area.

3. If there are no visible sex work sites, Outreach Workers can consult with any Non-Governmental Organisations that have established focused interventions with Commercial Sex Workers. These can assist in providing an estimation of the total number of sex work sites as well as the types of sex work occurring at these sites.

Component 3 – Screening of Mandals and Video Parlours:

1. In addition to the information on the number of mandals and video parlours and their basic characteristics provided in the main detailed mapping tool, Outreach Workers can conduct a detailed screening of these elements to assess their suitability with regard to communication programming;

2. A detailed screening tool should be conducted for each video parlour and mandal situated in each smaller pocket;

3. Video Parlours – Outreach Workers conduct in depth interviews with patrons and owners of each video parlour, using separate tools for owners and patrons (see Annexures 6 and 7). The questionnaire developed for patrons is quantitative, and the questionnaire developed for owners is qualitative. The latter also highlights the types of shows, number of shows on a daily basis, and the average number of patrons at each show;

4. Mandals– Outreach Workers conduct in depth interviews with presidents of mandals using the screening tool developed (see Annexure 4).

Component 4 – Drainage Assessment

The detailed mapping tool can provide refined information on target efficient hotspots. However, it may remain unclear whether the men who frequent these different spots are from the same area (i.e. the same group frequenting different spots) or from different areas. To assess this possible duplication, the following steps are necessary:

1. First, current field communication locations are marked on a map of the intervention area. Then Outreach Workers try to assess, for each particular spot, the predominant areas from which the target group members arrive, showing the drainage from various areas at that particular spot. These areas are marked on the map as areas that are being reached through current communication activities;

2. This assessment provides information on areas where there is overlap and consequently overexposure to field communication activities, as well as areas of non drainage (areas that are not being reached at all). In areas of overexposure, the frequency of field communication activities can be reduced. Targeted Interventions should be initiated for areas that are underexposed to field activities.

ANNEXURE 3

Preliminary Mapping

Location:

Draw a map of the geographical location (3 km radius, keeping the clinic as the centre).

Specify landmark to make the map.

1. Which is the nearest railway station in this area and how far away is it?

2. Which is the bus depot in this area and how far away is it?

3. How many markets are there in this area? List those names and number of shops.

4. How many cinema halls are there in this locality? List those names.

5. Are there any slums in the area? Please list their names.

6. Are there any residential colonies in the area? Please list these.

7. Is there any industry in the area?

8. How many bars are there in this locality? If possible please list those names.

9. Is there any RLD nearby? List those names.

10. Is there any Non-Government Organisation working in the area? List those names.

11. Is there any other point where adult males come together in the area? List those places. (Video Parlours, bissi, daily labour job posting points, etc.)

12. Is there any Truck Terminal, Auto or Taxi Stand, mechanic garage? List those places.

13. Other Information (a) Type of work; (b) Language; (c) Religion.

Note: Key Informants for preliminary mapping include:

(a) Shopkeepers in the market; (b) Cinema hall employees; (c) Residents of slum; (d) Resident of housing colonies; (e) Slum development office; (f) Brihanmumbai Municipal Corporation office; (g) Private doctor; (h) Government hospital doctor; (i) Non-Governmental Organisations; (j) Industry people: Employee and employer; (k) Bar: owner and clients; (l) Railway station master; (m) Bus depot in charge.[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2029

ANNEXURE 4

Detailed Mapping 1. Cluster Number:

2. Name of Locality:

3. Type of Locality: 1. Residential 2. Commercial 3. Residential & Commercial

4. Other ________________

4. Description of Structures:

5. Number of mandals:

6. Number of bhissis:

7. Number of video parlours:

8. Number of DLJPP:

9. Number of bars: Number of ladies service bars:

10. Potential spots for our activity:

11. Mandal Assessment Sheet

Type of audience

Area from where audience comes Willingness to

participate in Targeted

Intervention

Potential for Targeted

Intervention activity?

13. Labour Job Posting Points

14. Bhissi Assessment

15. Other areas of high male congregation:

16. Saloons with more than 3chairs:

1. 2. 3.

17. Pan Bidi+ tea stall (More than 7 people standing at a time)

1. 2. 3.

18. Commercial Sex Activity:

ANNEXURE 5

Female Sex Workers Assessment

ANNEXURE 6

Hotspot Screening (Owners) The script below is an example of how to ask questions to gather information about a hotspot and the population that frequents it. The example in this case is a video parlour, but similar information could be elicited from a different kind of hotspot. The factors to be investigated are:

(a) Length of experience of owner or facilitator of hotspot  (b) Days and times of operation  (c) Prices charged (where relevant)  (d) Languages or ethnic groups catered to  (e) Numbers of migrant population who frequent the hotspot, by each day of the week and at different times of day (f) Proportion of people who return  (g) Any other factors that influence migrant population members to frequent hotspot or participate in its activities

The script below is for guidance only; as the Outreach Worker establishes a report with the interviewee, the real­ life conversation can flow more naturally. However, it is important for the Outreach Worker to have a checklist of relevant questions so that he or she does not forget to ask for all the necessary information.

Namaste, My name is _____ and I work for an Non-Governmental Organisation named XXX. It is an Non-Governmental Organisation that works for the betterment of health of people. We are gathering information to learn more about people who are at risk of AIDS. Now, I want to gather some details about the different kinds of people who come to your parlour.

This information will help us serve people at risk of AIDS in a better way.

1. Could you please tell me since when are you running this video parlour? How many screens do you have, i.e. at one particular time how many movies you can show?

2. How many days of the week do you operate? What is your day(s) off?

3. What languages are your movies in?

4. What categories of movies do you show (family, action, erotic, etc.)?

5. Do you show all categories of movie everyday, or is there any particular day assigned for the particular category? If so, which categories of movies are shown on which days?

6. If this parlour has multiple screens, on how many screens do you show which category of movies?

7. What is the time gap between two shows?

8. How much do you charge for each movie? Is there a price difference between the categories of the movies? What is the detailed pricing?

9. I would like to know more about the types of people who visit your parlour. Please tell me what types of men generally come here their age, educational background and occupation.

Please give me a detailed idea of the average number of people coming per show on each day of the week.

Time Mon Tue Wed Thu Fri Sat Sun

11. Among the people who come to watch any particular show, what proportion of them comes back for another show?

12. Is there a day in the week when a large number of people come in comparison to other days? Is there any particular reason behind it?

13. Is there a time during the day when a large number of people come in comparison to other times? Is there any particular reason behind it?

14. How frequently you do change the movies, i.e. for how many days generally do you show a particular movie?

ANNEXURE 7

Hotspot Screening (Patrons)

The table below gives an example of the kinds of questions used to gather information about migrants who frequent a hotspot and their relationship to it. The example in this case is a video parlour, but similar information could be elicited from a different kind of hotspot, with a modified questionnaire. The factors to be investigated at any hotspot are:

(i) Age and educational background (ii) Geographic and linguistic origin (iii) Occupation and income (iv) Length of time in present location, and whom residing with (v) Timings and frequency of visits to hotspot, reasons for doing so and particular interests there (vi) Whether frequenting other hotspots (vii) Frequency of sexual behaviour during past 3 months (viii) Sexual partners and locations of sex The script below is for guidance only; as the Outreach Worker establishes a report with the interviewee, the real life conversation can flow more naturally. However, it is important for the Outreach Worker to have a checklist of relevant questions so that he or she does not forget to ask for all the necessary information.

Name of Video Parlour Code Movie Timings

01

02

03

04

05

06

07

08

09

10

Date_____________ ID CODE_______________ START TIME

END TIME

Day______________ Name of Interviewer ___________________[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2035

ANNEXURE 8

Model HIV or AIDS Workplace Policies

National AIDS Control Organisation guidelines on Strengthening HIV or AIDS interventions in

the world of work in India

To:

All Project Directors, State or District AIDS Control Societies Health Secretaries, State Governments and Union Territories

The AIDS Policy of the Government of India stresses that the organised and unorganised sector of industry needs to be mobilised for taking care of the health of the productive sections of their workforce.

Nearly 90% of the HIV infections have been reported from the most productive 15 49 years age group in India. If urgent efforts are not taken, this will adversely affect workers, their families, enterprise performance and the national economy. India has a working population of around 400 million, 93% of whom are in the informal economy, who are more difficult to reach. These workers are especially vulnerable to HIV or AIDS. Generally, they have low access to health care facilities and low health seeking behaviour. They have either no or low social protection benefits. It is, therefore, necessary to strengthen HIV or AIDS programmes in the world of work in India on an urgent basis.

No organisation can do it alone. This can happen if HIV or AIDS response becomes truly multi sectoral and HIV or AIDS is mainstreamed in the existing programmes of ministries, government departments, private sector, employers' organisations and trade unions or civil society organisations. To give highest priority to the mainstreaming process, a National Council on AIDS (NCA) has been set up in India, which is chaired by the Prime Minister. The objectives of NCA are:

(a) To mainstream HIV or AIDS in all ministries and departments by treating it as a development challenge, and not merely a public health problem;

(b) To provide leadership to mount a multi sectoral response to combat HIV or AIDS in the country with special reference to youth, women and the workforce.

These guidelines are issued with a view to help State AIDS Control Societies and other relevant stakeholders in strengthening HIV or AIDS response in the world of work at the national or State levels.

HIV or AIDS workplace policy:

State AIDS Control Society can assist government departments, private sector, employers' and workers' organisations to develop workplace policy, based on the national policy framework and the guidelines of the International Labour Organization Code of Practice on HIV or AIDS and the world of work. Key principles of the International Labour Organization Code around which policy can be developed are:

Recognition of HIV or AIDS as a workplace issue, non-discrimination due to HIV status, gender equality, creation of healthy

work environment, social dialogue, no HIV screening for the purpose of employment, respecting confidentiality regarding

HIV status, continuation of employment relationship as long as a person is fit to work, provision for HIV prevention efforts

through education and training of employees and their families, and care and support, including counselling of individuals or

families and treatment.

Operational or programmatic issues:

(1) State or District AIDS Control Societies should designate a staff member to coordinate workplace interventions at the State AIDS Control Society level. If it is not possible to dedicate a staff member from the existing personnel, a request may be made to National AIDS Control Organisation for seeking approval of a dedicated person to be appointed on contractual basis at the level of the Non- Governmental Organisation adviser.

(2) State AIDS Control Society should develop a clear work plan, with timeline and budget, which could be presently supported from the inter sectoral component under the State AIDS Control Society budget. If allocation is not available, State AIDS Control Society should seek funds from National AIDS Control Organisation by sending a work plan along these guidelines. State AIDS Control Society should include this component under the State PIP being prepared for National AIDS Control Programme III. State AIDS Control Society work plan for this component should cover the following areas:[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2043 a. Sensitisation or capacity building programmes for key departments, employers' organisations or chambers, trade unions, starting with main sectors in the states;

b. Assisting partners in developing their work plans, and supporting them in terms of training or materials or condoms. Enterprises should be encouraged to implement their work plans at their own cost. The support from State AIDS Control Society should be technical in nature related to policy development, training of peer educators, provision of communication materials, condoms and facilitating linkages with the Voluntary Counselling and Testing Centres or Sexually Transmitted Infection clinics or Antiretroviral Therapy centres. Enterprises should be encouraged to support the cost of treatment, including treatment with Antiretroviral drugs, for their employees or families as part of their policy. For contractual employees, they can set up linkages with government hospitals or Antiretroviral Therapy Centres or Employee State Insurance Corporation scheme, wherever applicable;

c. State AIDS Control Society can offer technical as well as financial support for projects of small and microenterprises and trade unions in the formal and informal sectors. It would be critical to identify entry points through industry associations, unions and other bodies' while developing these interventions. State AIDS Control Society can engage their partner Non-Governmental Organisations to help in this process;

d. State AIDS Control Society should support setting up Voluntary Counselling and Testing Centres in enterprises which have their own clinical set up. This will enhance the coverage of Voluntary Counselling and Testing Centres in the State;

e. State AIDS Control Society should also collaborate with the State labour departments, Central Board of Worker's Education and Employees State Insurance Corporation, two key institutions of the Ministry of Labour and Employment Government of India, who are engaged in the HIV or AIDS programme. Employee State Insurance Corporation scheme also covers for Antiretroviral Therapy drugs. However, State AIDS Control Society may like to collaborate with them for training of doctors, so that treatment protocols are correctly followed;

f. Involvement of People Living with HIV or AIDS is an effective strategy in the advocacy or training programmes which should be implemented in collaboration with the State level People Living with HIV or AIDS networks. This is also a good strategy for fighting HIV or AIDS related stigma and discrimination;

g. For covering workers in the informal economy, State AIDS Control Society are already supporting mobile and migrant workers through Non-Governmental Organisations in their Targeted Interventions projects. This coverage can be enhanced by carefully mapping the State specific vulnerable groups and developing composite projects through Non-Governmental Organisations. In addition, some more approaches can be attempted for enhancing; coverage. First, mainstreaming HIV or AIDS in the programmes of various government departments or schemes. Second, engaging civil society organisations Non-Governmental Organisations working in areas like adult education, health, Income generation, etc. to mainstream HIV or AIDS within their activities. Third, engaging trade unions in their areas where they have their sectoral unions like the agriculture workers unions, postal workers unions, plantation workers unions, transport workers union, construction workers union, etc. Fourth, encouraging corporate sector to cover their contractual workers as well as workers in their supply chains.

Technical support or materials for the world of work programme:

State AIDS Control Society can utilise the following set of materials that have been developed by International Labour Organization India to support HIV or AIDS interventions in the world of work:

(a) The International Labour Organization Code Of Practice, available in English and Hindi, for policy and programmatic guidelines.

(b) An Indian Employers Statement of Commitment on HIV or AIDS, signed by seven key employers organisations or chambers in India: All India Organisation of Employers, Associated Chambers of Commerce and Industry of India, Confederation of Indian Industries, Employers' Federation of India, Federation of Indian Chambers of Commerce and Industry, Standing Conference of Public Enterprises and Laghu Udyog Bharati. This statement is published along with a working paper on "Enhancing Business response to HIV or AIDS in India­ Operational Guidelines with estimated Cost Analysis".

(c) A Compendium of Workplace HIV or AIDS policies.

(d) A Training manual for Master Trainers or Peer Educators of enterprises (includes the enterprise based strategy as well).2044 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] (e) A CD containing an advocacy film for enterprise, training manual, key presentations and collocation of audio visual spots for enterprise based programmes.

(f) A bilingual (English and Hindi) card game for workplace peer educators.

(g) A training manual for trade unions in English and Hindi, a handbook and a film on role of trade unions on HIV or AIDS in English and Hindi.

(h) A set of six posters on HIV or AIDS and the world of work.

(i) A flip book for unorganised sector workers, produced by International Labour Organization and Central Board of Worker's Education.

(j) A handbook for labour administrators in English, produced by International Labour Organization and V.V. Giri National Labour Institute.

The International Labour Organization materials are available at www.ilo.org/hivaidsindia. International Labour Organization will be sending a complete set of materials to State AIDS Control Society. The International Labour Organization is also willing to share the text or art work of posters or materials with State AIDS Control Society, which could be adapted or translated into regional languages and replicated by State AIDS Control Society.

ANNEXURE 9

Information Collection in Stakeholder Analysis

Introduction Participatory tools are particularly useful when outreach work involves the exchange of sensitive or private information. Groups like migrants and sex workers themselves can give key insights on existing behaviour, attitudes and practices and barriers to safer behaviours. Hence it is worth investing in training Non-Governmental Organisation partners and peers in the basics of participatory techniques. These can be useful not only in the start up phase but throughout the project cycle when different messages and Behaviour Change Communication need to be planned, designed and developed.

There are many references and guidelines for participatory techniques for collecting quantitative and qualitative data. Some of these are summarised below.

Mapping Mapping is an effective Participatory rural appraisal technique for gathering information that captures the complexity of local situations. It helps locate important landmarks in an area and identifies Key Informants or guides. Mapping permits the rapid assessment and analysis of a particular situation with the goal of providing accurate, timely information that can be used to develop intervention strategies. An important advantage of this method is that it can be used effectively with uneducated target groups.

Mapping can collect information on:

1) Exact locations within the clusters in which the target population reside or operate

2) Validation of estimates of target population in each intervention site

3) Social networks, brothels, truckers halt points, drug using points, beer bars, lodges, video parlours, and places where street based sex workers operate

4) Service facilities such as government or municipal health clinics, family planning clinics, hospitals, Sexually Transmitted Infection or drug abuse treatment centres, primary health care centres, medical colleges, Voluntary Counselling and Testing Centres and other health care facilities. This information can be useful for building a referral network during intervention.

5) Traditional and non traditional outlets which currently stock or sell condoms

6) Other outlets or persons or places which are potential condom outlets

7) Other infrastructure, e.g. parks and gardens, water tanks, public toilets and private properties[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2045

Mapping Information Form

Key Informant Interviewing

Separate interviews can be conducted with Key Informants of the community. This is considered an effective methodology to collect correct information about migrants, as Key Informants are intimately involved with or exposed to them. Key Informants are individuals with special knowledge, status, or communication skills who are willing to share what they know with the intervention team. They usually have direct expert knowledge, or are identified as an expert by others and can give detailed as well as contextual information. They also have a different relationship to the migrant community than the interviewer or researcher in terms of providing information, introductions and interpretations, often an a day to day basis, as well as access to observations that an outsider would not normally have.

An illustrative list of who could be productive Key Informant could include:

(a) Administrators and officials, e.g. lawyers, judges, police, doctors and paramedics, teachers, etc.;  (b) Street vendors, taxi or auto drivers, traditional healers, youth club members, community leaders, Non-Governmental Organisation personnel, dhaba owners, barbers, etc.;

(c) Members of the migrant community and power brokers, migrants, Female Sex Workers, union and Labour Department officials.2046 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)]

Key informants Interview Checklist

Secondary Sources

Secondary sources are materials already published or recorded by others (individuals, research institutions and papers, records and registers), including reference works, data from surveys and existing records.

Focus Group Discussion

Focus group discussion is a method for eliciting qualitative information from a homogeneous group interaction, in order to produce data and insights that would be less accessible without the interaction found in a group. The key concept here is group interaction. Unlike simple group interviews, Focused Group Discussions depend as much on the exchange of ideas among participants as they do on answers to specific questions from the interviewer. In a Focused Group Discussion, the interviewer is in fact called a moderator, underscoring the role of guide and facilitator in the group process.

Focused Group Discussions can be highly effective sources of data for studies that focus on social norms, expectations, values and beliefs. These stimulate people to share their own ideas and debate the view of others. Most Focused Group Discussions have relatively homogenous groups with respect to age, sex and backgrounds, e.g. a group of migrant labourers of the same age and sex, or a group of community influencers from a particular community.

Checklist for Focused Group Discussion

In Depth Interview

The in depth interview is a qualitative research technique used to get more detailed information on issues which can not be fully elicited from a focus group discussion, e.g. a life history. It is similar to a Focused Group Discussion, but the interview takes place with one individual rather than a group of individuals. The facilitator uses a pre designed flexible discussion guide, leaving most questions open ended.

In depth interviews require an experienced facilitator with the skills to carry an interview by him or herself to gain maximum information. As with the Focused Group Discussion, the interview is so far as is possible to be recorded manually or by tape recorder after receiving the respondent's permission.

ANNEXURE 10

Referral Slip

ANNEXURE 11

Ongoing Assessment of Volunteer Peer Leaders and Migrants Ongoing Assessment Tool for Volunteer Peer Leaders

under Migrant Targeted Interventions

Ongoing Assessment Tool for Migrants within Targeted Interventions

नई दिल्ली, 14 अगस्त, 2020

मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 की उप-धारा (1) उपबंध करती है कि केन्द्रीय सरकार सामान्यतः उक्त अधिनियम के उपबंधों को कार्यान्वित करने हेतु, उक्त अधिनियम और उसकेे अधीन बनाए गए नियमों से संगत मार्गदर्शन बना सकेगी;

और उक्त धारा की उप-धारा (2), अन्य बातों के साथ-साथ, केन्द्रीय सरकार को लिंक श्रमिक स्कीम परिचालन मार्गदर्शन, 2018 बनाने के लिए सशक्त करती है;

अतः, अब, केन्द्रीय सरकार मानव रोगक्षम अल्पता विषाणु और अर्जित रोगक्षम अल्पता संलक्षण (निवारण और नियंत्रण) अधिनियम, 2017 (2017 का 16) की धारा 46 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए इस अधिसूचना से उपाबद्ध अनुसूची के अनुसार "लिंक श्रमिक स्कीम परिचालन मार्गदर्शन, 2018" अधिसूचित करती है।

[फा. सं. टी-11020/50/1999-नाको (पी एंड सी)]

आलोक सक्सेना, संयुक्त सचिव

New Delhi, the 14th August, 2020

S.O.684 .—Whereas sub-section (1) of section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017) provides that the Central Government may make guidelines consistent with the said Act and any rules made there under, generally to carry out the provisions of the said Act;

And whereas sub-section (2) of the said section, inter alia, empowers the Central Government to make Link Workers Scheme Operational Guidelines, 2018;

Now, therefore, in exercise of the powers conferred by section 46 of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (16 of 2017), the Central Government hereby notifies the "Link Workers Scheme Operational Guidelines, 2018" as per the Schedule annexed to this notification.

[F. No. T-11020/50/1999-NACO (P&C)]

ALOK SAXENA, Jt. Secy.

SCHEDULE

LINK WORKERS SCHEME OPERATIONAL

GUIDELINES

Targeted Interventions Division, 2018

Contents

CONTENTS ....................................................................................................................................... 4 FOREWORD ..................................................................................................................................... 7 PREFACE .......................................................................................................................................... 9 ABBREVIATIONS .............................................................................................................................. 10 INTRODUCTION ............................................................................................................................... 12 OBJECTIVES OF LINK WORKER SCHEME ......................................................................................... 15 PURPOSE OF THE GUIDELINES ........................................................................................................ 15 TARGET AUDIENCE OF THE GUIDELINES ........................................................................................ 15 SALIENT FEATURES OF LINK WORKERS SCHEME ............................................................................ 16 SERVICES PROVIDED UNDER LINK WORKERS SCHEME ................................................................. 16 Operational Definitions used in the Guidelines ............................................................................. 18 Organogram of Implementation and Management of Link Workers Scheme ............................... 22 Organogram of Implementation of Link Workers Scheme at Non-Governmental 22 Organisation level ...........................................................................................................................

CHAPTER 1:RATIONALE FOR PREVENTION INTERVENTIONS AMONG RISK AND 23 VULNERABLE POPULATION INRURAL AREA ...................................................................................

1.1 RATIONALE FOR PREVENTION INTERVENTIONS AMONG RISK AND VULNERABLE 24 POPULATIONIN RURAL AREA ..........................................................................................................

1.2 HIV RISK AMONG RURAL POPULATION .................................................................................... 25 1.3 FACTORS WHICH MAKE RURAL POPULATION VULNERABLE TO HIV........................................ 25 Take home messages: ..................................................................................................................... 26

27 CHAPTER 2: GUIDELINES FOR STATE AIDS CONTROL SOCIETIES AND TECHNICAL SUPPORT UNIT ................................................................................................................................................

Role of State AIDS Control Societies and Technical Support Unit: ................................................. 28 Role of State AIDS Control Societies: .............................................................................................. 28 Role of Technical Support Unit ............................................................................................. 292058 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] Role of Technical Support Unit Project Officer ..................................................................... 30 2.1 DEFINING THE TARGET POPULATION AT RISK AND SITE ASSESSMENT ....................... 31 Steps in Defining the target population at risk ..................................................................... 32 2.2 DEFINING THE LOCATION WHERE THE SCHEME CAN BE IMPLEMENTED...................... 33 Exclusion criteria for both Broad Mapping and Site Assessment.......................................... 34 Target Setting for Link Worker Scheme Districts: ..........................................................(cid:13)…….. 38 2.2 DETERMINING AVAILABILITY OF APPROPRIATE SERVICES ............................................ 41 2.3 CAPACITY BUILDING OF IMPLEMENTING PARTNERS ………............................................ 42 2.4 MONITORING AND EVALUATION .................................................................................. 44 Specific Strategy for North Eastern States and Tribal areas ................................................. 44 Take home messages: ........................................................................................................... 45 CHAPTER 3: GUIDELINES FOR IMPLEMENTING PARTNERS ................................................... 46

47 3.1 PRINCIPLES OF SERVICE DELIVERY AMONG RISKY AND VULNERABLE POPULATION IN A RURAL SETTING …………………………………………………………………………………………………………...

3.2 PROGRAMME STRATEGIES ............................................................................................ 48 Different Service Delivery Models ........................................................................................ 50 3.3 COMPONENTS OF SERVICE DELIVERY ........................................................................... 51 Behavioural Component ....................................................................................................... 51 Bio-medical Component ....................................................................................................... 61 Positive Prevention Services: ................................................................................................ 63 3.5 HUMAN RESOURCE MANAGEMENT ............................................................................. 70 Take home messages: ........................................................................................................... 71[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2059 CHAPTER 4: REPORTING AND DOCUMENTATION AND QUALITY ASSURANCE MECHANISM. ……………………………………………………………….…………………………………………………. 72 4.1 DOCUMENTATION AND REPORTING ............................................................................. 73 4.3 QUALITY ASSURANCE MECHANISMS ............................................................................ 74 5.1 MONITORING AND EVALUATION ........................................................................................... 75 5.1.1 PERFORMANCE INDICATORS ................................................................................................. 75 CHAPTER 6: ROLE OF STAKEHOLDERS ............................................................................................ 78 6.1 ROLE OF STAKEHOLDERS ......................................................................................................... 79 ANNEXURES .................................................................................................................................... 82 Annexure 1 (Format for line listing cum service tracking sheet) ................................................... 83 Annexure 2 (Line list format for migrants) ..................................................................................... 84 Annexure 3: Interpersonal Communication Tools ......................................................................... 90 85 Annexure 4 (Referral and Linkage register for Cluster Link Workers) ........................................... 88 Annexure 5 (Referral and Linkage monitoring formats for Zonal supervisor) .............................. 89 Annexure 6 (Stock and Issue register for Cluster Link Workers) ................................................... 90 Annexure 6a (Stock and Issue register for District level) .............................................................. 91 Annexure 7: (Visit report) ............................................................................................................... 93 Annexure 8 (Meeting activities register) ....................................................................................... 94 Annexure 9: Recruitment Process ................................................................................................. 95 Annexure 10 (Human Resources) .................................................................................................. 96 Annexure 11 (Monthly Reporting Format) .................................................................................... 97 Reporting Requirements: ............................................................................................................... 100 Data definitions: ............................................................................................................................. 1012060 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)]

Abbreviations

INTRODUCTION

In this chapter, the following areas are covered:

(i) The key strategies of National AIDS Control Programme-IV and relevance of Link Workers Scheme (ii) Objectives, Purposes and Target audiences of the Guidelines



(iii) Salient features of the Guidelines

(iv) Services provided under Link Workers Scheme

(v) Operational definitions used in the Guidelines

(vi) Organogram of implementation of the Link Worker Scheme

The key strategies of National AIDS Control Programme-IV (part of National AIDS Control Support Project) focuses on intensifying and consolidating prevention services with a focus on High Risk Groups and vulnerable population as well as expanding Information, Education and Communication services for High Risk Groups with a focus on behaviour change and demand generation and increasing access and promoting comprehensive care, support and treatment. These key strategies hold good in a way to consolidate the gains achieved during third phase as well as expand those learning to emerging pockets of epidemic.

The HIV epidemic in India continues to be heterogenic, especially in terms of its geographical spread. As per the Technical Brief of HIV Sentinel Surveillance 2012-13, the declining trend among Antenatal Care clients, considered as a proxy for general population, is consistent with India's story of large scale implementation and high coverage during Third Phase of National AIDS Control Programme.

The HIV Sentinel Surveillance, 2012-13 also highlights that although the overall HIV prevalence continues to be low as 0.35%, there are about 80 sites which shows more than 1% prevalence and 12 sites with more than 2% prevalence. Some of these sites are in the moderate and low prevalence States of Bihar, Chhattisgarh, Gujarat, Madhya Pradesh, Jharkhand, Odisha, Rajasthan, Uttar Pradesh and West Bengal. Similarly, HIV Sentinel Surveillance 2010-11 highlights that there is significant decline in prevalence among High Risk Groups (i.e. Female Sex Workers, Men Who Have Sex with Men) except in case of Injecting Drug Users the prevalence remains consistent.

HIV Sentinel Surveillance 2010-11 highlights that some low prevalence States in west, north and east India have demonstrated a stable to rising trend. This rising trend in moderate and low prevalence States is interpreted by the growing understanding for need of high intensity interventions, saturation of coverage of High Risk Groups especially in rural areas, improving access to testing and treatment services. During National AIDS Control Programme-III, National AIDS Control Organisation had invested significant resources and garnered political leadership to bring in these State's capacity and strengthen response.

Although, during National AIDS Control Programme-III, the coverage of Female Sex Workers (81%), Men Who Have Sex with Men (67%) and Injecting Drug User (81%) through a total of around 1821 Targeted Interventions for High Risk Groups and Bridge Population was achieved mainly in urban and peri-urban areas, the coverage of rural High Risk Groups and vulnerable population remained comparatively challenged. During National AIDS Control Programme-III, the coverage and understanding of rural sex- work dynamics, impact of migration related transmission dynamics has evolved through implementation of Link Worker Scheme in selected Districts in India. During National AIDS Control Programme-III by the end of March 2012, the Scheme covered about 1,60,000 High Risk Group, 18,70,000 Vulnerable Population and 37,000 People Living with HIV. Nearly 59% High Risk Groups have been tested at Integrated Counselling and Testing Centre and 58% High Risk Groups have been referred to Sexually Transmitted Infections services under this intervention. This has been done by establishing linkages with existing services. In order to create a sense of ownership in the community and involve the youth in fighting against HIV, 13,296 Red Ribbon Clubs and 21,170 Information Centres had been established at the village level by March, 2012.

From these evidences it is clear that there is a need for comprehensive interventions focusing at community level to reach out rural High Risk Groups and vulnerable population to achieve the accelerated response considering the emerging epidemic drivers in India especially that of rural Antenatal Clinic prevalence being higher than urban Antenatal Clinic prevalence in moderate and low prevalence States (HIV Sentinel Surveillance, 2010-11), spouses of migrants having four times higher risk than non- migrants (Male out-migration: a factor for the spread of HIV infection among married men and women in rural India, PLOS One, September 06, 2012).

The following figure shows the importance of rural High Risk Groups and vulnerable population in the context of HIV transmission dynamics:

Population at High Risk

Vulnerable Population (rural Female Sex Workers People who inject drugs Men Who Have Sex

Low risk but

highly

vulnerable

population areas)

with Men

Transgender

Spouses of high risk groups

Truckers, Regular partners and casual Migrants, partners of Bridge Population Spouses of High Risk Groups who also act as commercial partners

The above diagram highlights the fact that until now, the focus on population at high risk and Bridge Population has resulted significant decline, but the emerging epidemic drivers due to2066 THE GAZETTE OF INDIA : AUGUST 22, 2020/SRAVANA 31, 1942 [PART II—SEC. 3(ii)] selected groups among general population in rural areas also need to be targeted adequately and comprehensively maintain the responses achieved. This is possible once the interventions are designed and implemented in a community environment by the community volunteers as is being carried out under Link Workers Scheme.

OBJECTIVES OF LINK WORKERS SCHEME

1. The scheme aims at building a rural community model to address the complex needs of rural HIV prevention, care and support requirements in selected geographies.

2. The scheme aims at reaching out to rural population who are vulnerable and are at risk of HIV or AIDS in a non-stigmatised enabling environment.

3. The scheme aims at improving access to information materials, commodities (condoms, needles or syringes) through collaborating with nearest Targeted Interventions or government health facilities, testing and treatment services ensuring there is no duplication of services or resources.

4. The scheme aims at improving linkage to other social and health benefits provided by other line departments in line with local norms, regulations suitable for vulnerable populations.

PURPOSE OF THE GUIDELINES

The purpose of these revised operational Guidelines is to ensure delivery of quality HIV prevention interventions with strong linkage for access to testing and treatment under National Programme for rural High Risk Groups and vulnerable population in selected Districts of India. The Guidelines outline standardised operating procedures for implementing comprehensive HIV prevention services on a scale. In summary the purposes of the Guidelines are:

1. Build in uniform understanding about the need, design and outcomes of prevention interventions among rural High Risk Groups and vulnerable population across all stakeholders, users.

2. Bring in technical competence among implementers, managers and technical support persons.

3. Bring in performance benchmarks and quality interventions to contribute to the National Goal.

TARGET AUDIENCE OF THE GUIDELINES

These Guidelines have been developed for the following audience:

(i) Policy Makers (Ministry of Health and Family Welfare through National AIDS Control Organisation, Ministry of Women and Child Development, Ministry of Rural Development, Ministry of Panchayati Raj and other line departments).

(ii) Programme Team of State Level and National AIDS Control Organisation level

(iii) Implementing partners (Non-Governmental Organisations, Community Based Organisations and Collaborating partners; Staff working in the Targeted Interventions, Integrated Counselling and Testing Centre and Antiretroviral Treatment centres; Private Health Organisations or individual providers etc.)[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2067 It is recommended that all organisations using these Guidelines consider each of the proposed elements in the context of the organisation's current environment and other relevant guidelines published by National AIDS Control Organisation.

SALIENT FEATURES OF LINK WORKER SCHEME

The salient features of this scheme are as follows:

1. The scheme uses evidence-based approach to identify rural areas having greater risk and vulnerabilities of contracting HIV through scientific tools such as Broad Mapping.

Individuals/groups within the villages are identified for providing information and services based on detailed Situation Needs Assessments.

2. The scheme envisages creation of demand for various HIV or AIDS related services and the linking of the target population to existing services. The scheme itself does not create any service delivery points.

3. The scheme involves highly motivated and trained community members – preferably a male or female Cluster Link Worker for clusters of villages – who will establish linkages between the community on one hand and information, commodities and services on the other.

4. The scheme envisages creating an enabling and stigma free environment in the project area to ensure that the target population continue to access information, services in a sustained manner.

5. The scheme envisages creating linkages with services of other departments through Accredited Social Health Activist volunteers, Anganwadi Workers, Panchayat heads, Mahatma Gandhi National Employment Guarantee Act scheme officials etc. This is to ensure that the vulnerabilities are identified and addressed by building capacity of ground level stakeholders.

SERVICES PROVIDED UNDER LINK WORKERS SCHEME

However, under this scheme youth with Sexually Transmitted Infections, with high risk practices, who are known to be clients of High Risk Groups, who are HIV positive or Tuberculosis Bacili patients, who are on Antiretroviral Treatment are targeted more intensely. Otherwise in general youth are covered through mid or mass media activities.

Operational Definitions used in the Guidelines

High Risk Groups in rural context:

a. Female Sex Workers: Women who sell sex. Includes women who live and practice sex work in the village, women who live in the village but practice sex work outside the village, and women who practice sex work in the village but live outside the village. Excludes women who used to be sex workers in the past and are currently not entertaining clients since last three months. Focus would be on Female Sex Workers who are high volume (more than 8 clients in 15 days) and medium volume (5 to 8 clients in 15 days), those who are highly mobile i.e. travelling at least 10 days a month outside the village. Also Female Sex Workers who are being covered by Targeted Interventions but they visit Targeted Interventions irregularly and there is evidence of services being discontinued.

b. Men Who Have Sex with Men: Men who engage in anal sex with men. Includes men who live and engage in anal sex with other men in the village and with men outside the village and those who have anal sex with men in casual partnerships or in commercial relationships.

c. Transgenders (Hijras) who sell or buy sex with regular or commercial partners.

d. Injecting Drug Users: Injecting Drug Users are defined as those who used any drugs through injecting routes in the last three months. Injecting Drug Users may live and inject drugs in the village, live in the village but inject drugs outside the village, and inject drugs in the village but do not live in the village. Some Injecting Drug Users might be sex workers or Men Who Have Sex with Men and some of them are also female. For Female Injecting Drug Users standard definitions of National AIDS Control Organisation shall be used including services.

People Living with HIV: Persons infected by HIV are considered to be high risk in case they do not continue to maintain positive prevention practices. Suppose a positive man continues to have multi- partner sex without condoms.

Bridge Population who are highly vulnerable:

a. At risk men including clients of Female Sex Workers or Men Who Have Sex with Men: Includes commercial drivers and cleaners who live in the village and work within or outside the village, migrant workers (single men or women) who come into the village or go outside the village for work/business for a short duration. Excludes long-term migrants who migrate for more than once a year. Includes spouses of Female Sex Workers also.

b. At risk women: Women who have casual multiple partners including Female Sex Workers. Spouses of Men Who Have Sex with Men or Male Sex Workers and Injecting Drug Users who are also High Risk Groups.

c. Pregnant Mothers from the point of vertical transmission and preventing them by ensuring early testing and necessary support during delivery.

Migrants: As per the definitions of revised migrant strategy, these are men or women who migrate to high prevalence Districts or towns or cities within or outside the State and have evidence of risk exposure (buying or selling sex; injecting habits based on information from the destination intervention or HIV Sentinel Surveillance). These migrants must be circular and of short duration, thus having the risk of carrying HIV from one place to another.

Mobile Population: Significant populations of the village move to nearby towns for work or business and they may come back on the same day or during the weekend. In case it was found that in the nearby town where they move also have High Risk Groups and during discussion with these High Risk Groups it was found that these groups also buy or sell sex during their stay in the town. Then it is important that these groups need to be covered.

Bridge Population with low vulnerability:

a. Partners or spouses of migrant or mobile men and women

b. Partners or spouses of commercial drivers or cleaners

c. Men Who Have Sex with Men (not necessarily anal sex)

d. Injecting Drug Users (not necessarily sharing needles)

e. Youth Population who have Sexually Transmitted Infections or HIV, who are Tuberculosis Bacili patients, who are known to be clients of High Risk Groups, who are on Antiretroviral Treatment.

Cluster Link Worker: Under this scheme, a person who has been trained and has been made responsible to carry out specific activities is called a Cluster Link Worker. The person can be male or female depending upon the requirements of the District. He or She is expected to reach out to the above groups, link them with services and follow up for continuous uptake of services. Other activities as required are also expected to be carried out by the Cluster Link Workers.

Target District: New Districts are to be identified based on the risk and vulnerability parameters provided in the Guidelines. These Districts shall have significant number of High Risk Groups in rural areas (who are high or medium volume and are concentrated in pockets), high out migration with significant positivity among migrants or their spouses, high number of People Living with HIV concentrated in pockets will be considered on priority. In addition Tuberculosis Bacili incidences and Prevention of Parent to Child Transmission coverage will add in deciding the selection of the District.

Target Blocks: New or Existing Blocks may be reconfigured based on the following criteria:

• At least 40% of the villages which are located at least 10 kms (5kms in hilly or Districts with low population density) or more from the head quarter and having significant number of High Risk Groups (who are high or medium volume and are concentrated in pockets), high out migration with significant positivity among migrants or their spouses, high number of People Living with HIV concentrated in pockets.

• One or more Blocks can be clubbed together to make it one cluster for operation may be considered even if these Blocks are from two different Districts. However, the Districts should have only one implementing agency. If separate agencies are available then this cannot be considered.[भाग II—खण्ड 3(ii)] भारत का राजपत्र : अगस्त 22, 2020/श्रावण 31, 1942 2071 Target Area: The target area would be one village or a number of villages. The selection of village would be based on three basic assumptions.

1) Number of pregnant mothers (including spouses of high risk men or women, spouses of migrants) to be covered.

2) Number of High Risk Groups (as defined above) and or at least 40% of the households are having short, circular migration.

3) Number of Tuberculosis Bacili patients and People Living with HIV in the village or cluster of villages

Hotspots: These are solicitation sites of Female Sex Workers, Male Sex Workers, Transgender. These sites may be within a village, along the national highways or in dhabas near the village, at the weekly market place near the village, nearby town, nearby lodges or brothels or any other place which will be beneficial for the programme to reach out and provide information and condoms.

Hotspot for Injecting Drug Users: These are places within a site where significant concentration of Injecting Drug Users come together for various purposes including injecting of drugs, taking rest or during crisis events (abuse by family, public or police).

Sites: These are congregation points where congregation of above target population occurs for various purposes not necessarily for high risk activities. Every site cannot be a hotspot but each hotspot may also be a site as well.

Truckers: In India, these are male who primarily drive trucks. They may start from the originating station, they may board at any place in between the originating and destination points. They may be employed by the transport companies or are on contract basis, however no formal contract exists.

But for HIV programme point of view in rural areas the truckers (including helpers) are defined as those

who are plying trucks in and around the area for various purposes, they may belong to the same village

or may be coming to the village for business purposes and having significant risk for HIV.

Mid-media: These are forms of communication where the communicator (Cluster Link Worker, ORW or a group) reaches to more than eight people with contents relevant to the group. However, there is limited participation of the group with the communicator. These may be in the form of skits, plays, musical programmes, games etc.

Mass media: Mass media provides a means of expanding programme messages and creating demand beyond the boundaries of the intervention. It has the added advantage of reaching the population outside a formal intervention environment. However, there is no participation of the group with the communicator. These may be in the form of posters, pamphlets, hoardings, short films, short text message, social media etc. These include wall writings, posters, danglers with specific messages.

Social Marketing of condoms: In the process, condoms are marketed by outlets in an accessible place in the villages. This can be a paan shop, tea shop, grocery shop or can be an individual. By marketing these condoms the outlet holder makes some profit and this helps him/her motivated to be engaged for a social cause. In rural context, condoms can be marketed with sanitary pads, Oral Rehydration Salt pouches etc.

Health Camps: These are specific events organised at Panchayat Level especially during festivals when migrants return to their villages. This helps everybody to get their health checked up as well as undergo HIV counselling and testing. These shall be organised with prior consultation with State AIDS Control Societies and local District Health Society. So that there is no duplication and necessary support can be provided. Ideally the doctors, medicines and Information, Education and Communication the materials, condoms are to be provided by District Health Society and State AIDS Control Societies shall provided testing and counselling support. A detailed guideline on conducting health camps may be referred from State AIDS Control Societies or National AIDS Control Organisation.