Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India

BMC Health Services Research

Volumn 16, Issue 1, 2016, Pages 1-14

  Solomon, Sunil S ^a,b,c   Lucas, Gregory M ^a   Celentano, David D ^b   McFall, Allison M ^b   Ogburn, Elizabeth ^b   Moulton, Lawrence H ^b   Srikrishnan, Aylur K ^c   Kumar, M Suresh ^c   Anand, Santhanam ^c   Solomon, Suniti ^c   Mehta, Shruti H ^b  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c YRG CENTRE FOR AIDS RESEARCH AND EDUCATION   (India)

Author keywords

HIV ADS; India; Men who have sex with men; People who inject drugs

Indexed keywords

ADOLESCENT; ADULT; AGED; CITY; CONTROLLED STUDY; COUNSELING; CROSS-SECTIONAL STUDY; HEALTH CENTER; HIGH RISK BEHAVIOR; HIV INFECTIONS; HUMAN; INDIA; INTEGRATED HEALTH CARE SYSTEM; MALE; MALE HOMOSEXUALITY; MASS SCREENING; MIDDLE AGED; PATIENT CARE; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL; REHABILITATION; SEXUALLY TRANSMITTED DISEASES; STANDARDS; SUBSTANCE ABUSE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; CITIES; COMMUNITY HEALTH CENTERS; CONTINUITY OF PATIENT CARE; COUNSELING; CROSS-SECTIONAL STUDIES; DELIVERY OF HEALTH CARE, INTEGRATED; HIV INFECTIONS; HOMOSEXUALITY, MALE; HUMANS; INDIA; MALE; MASS SCREENING; MIDDLE AGED; RISK-TAKING; SEXUALLY TRANSMITTED DISEASES; SUBSTANCE ABUSE, INTRAVENOUS; YOUNG ADULT;

EID: 84999266389     PISSN: None     EISSN: 14726963     Source Type: Journal    
DOI: 10.1186/s12913-016-1905-5     Document Type: Article

References (69)

1. National AIDS Control Organization. HIV Sentinel Surveillance 2014-15: A Technical Brief. 2015. http://www.aidsdatahub.org/sites/default/files/highlight-reference/document/India_HSS_report_2014-15.pdf. Accessed 8 Aug 2016.
2. Singh NB, Singh YI, Singh NC, Singh EK. Seroprevalence of HIV infection in high risk groups in Manipur. J Commun Dis. 1987;19(4):373-6.
3. Tanne JH. AIDS spreads eastward. BMJ. 1991;302(6792):1557.
4. Sehgal PN. Shocking findings in Manipur. Health Millions. 1991;17(4):26-8.
5. UNAIDS. 2013 Report of the Global AIDS Epidemic. Joint United Nations Programme on HIV/AIDS. 2013. http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf. Accessed 31 Dec 2014.
6. Solomon SS, Mehta SH, Srikrishanan AK, Vasudevan CK, McFall AM, Balakrishnan P, et al. High HIV prevalence and incidence among men who have sex with men (MSM) across 12 cities in India. AIDS. 2015;29:723-31.
7. Lucas G, Solomon SS, Srikrishanan A, Agrawal A, Iqbal SH, Laeyendecker O, et al. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015;29(5):619-28.
8. National AIDS Control Organization. 2006 Annual HIV Sentinel Surveillance Country Report. National AIDS Control Organisation, Institute of Health and Family Welfare. 2006. http://www.nacoonline.org/Quick_Links/HIV_Data/. Accessed 12 Dec 2006.
9. Verma RK, Collumbien M. Homosexual activity among rural Indian men: implications for HIV interventions. AIDS. 2004;18(13):1845-7.
10. Kar N, Koola MM. A pilot survey of sexual functioning and preferences in a sample of English-speaking adults from a small South Indian town. J Sex Med. 2007;4(5):1254-61.
11. Herget G. India: UNAIDS claims law criminalizing homosexuality hinders HIV prevention. HIV AIDS Policy Law Rev. 2006;11(1):35-6.
12. Asthana S, Oostvogels R. The social construction of male 'homosexuality' in India: implications for HIV transmission and prevention. Soc Sci Med. 2001;52(5):707-21.
13. Go VF, Srikrishnan AK, Sivaram S, Murugavel GK, Galai N, Johnson SC, et al. High HIV prevalence and risk behaviors in men who have sex with men in Chennai, India. J Acquir Immune Defic Syndr. 2004;35(3):314-9.
14. Brahmam GN, Kodavalla V, Rajkumar H, Rachakulla HK, Kallam S, Myakala SP, et al. Sexual practices, HIV and sexually transmitted infections among self-identified men who have sex with men in four high HIV prevalence states of India. AIDS. 2008;22 Suppl 5:S45-57.
15. Hernandez AL, Lindan CP, Mathur M, Ekstrand M, Madhivanan P, Stein ES, et al. Sexual behavior among men who have sex with women, men, and Hijras in Mumbai, India-multiple sexual risks. AIDS Behav. 2006;10(4 Suppl):S5-16.
16. Shinde S, Setia MS, Row-Kavi A, Anand V, Jerajani H. Male sex workers: are we ignoring a risk group in Mumbai, India? Indian J Dermatol Venereol Leprol. 2009;75(1):41-6.
17. Setia MS, Lindan C, Jerajani HR, Kumta S, Ekstrand M, Mathur M, et al. Men who have sex with men and transgenders in Mumbai, India: an emerging risk group for STIs and HIV. Indian J Dermatol Venereol Leprol. 2006;72(6):425-31.
18. Solomon SS, Srikrishnan AK, Sifakis F, Mehta SH, Vasudevan CK, Balakrishnan P, et al. The emerging HIV epidemic among men who have sex with men in Tamil Nadu, India: geographic diffusion and bisexual concurrency. AIDS Behav. 2010;14(5):1001-10.
19. United Nations Office on Drugs and Crime. World Drug Report. 2008. http://www.unodc.org/documents/wdr/WDR_2008/WDR_2008_eng_web.pdf. Accessed 31 Dec 2014.
20. Aceijas C, Friedman SR, Cooper HL, Wiessing L, Stimson GV, Hickman M. Estimates of injecting drug users at the national and local level in developing and transitional countries, and gender and age distribution. Sex Transm Infect. 2006;82 Suppl 3:10-7.
21. Mathers BM, Degenhardt L, Phillips B, Wiessing L, Hickman M, Strathdee SA, et al. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. Lancet. 2008;372(9651):1733-45.
22. Baveja UK, Chattopadhya D, Khera R, Joshi PM. A cross sectional serological study of the co-infection of hepatitis b virus, hepatitis c virus and human immunodeficiency virus amongst a cohort of idus at Delhi. Indian J Med Microbiol. 2003;21(4):280-3.
23. Kumar MS, Mudaliar S, Thyagarajan SP, Kumar S, Selvanayagam A, Daniels D. Rapid assessment and response to injecting drug use in Madras, south India. Int J Drug Policy. 2000;11(1-2):83-98.
24. Panda S, Chatterjee A, Sarkar S, Jalan KN, Maitra T, Mukherjee S, et al. Injection drug use in Calcutta: a potential focus for an explosive HIV epidemic. Drug Alcohol Rev. 1997;16(1):17-23.
25. Solomon SS, Desai M, Srikrishnan AK, Thamburaj E, Vasudevan CK, Kumar MS, et al. The profile of injection drug users in Chennai, India: identification of risk behaviours and implications for interventions. Subst Use Misuse. 2010;45(3):354-67.
26. Ambekar A. HIV prevention among injecting drug users and their female sex partners implementation gaps and barriers: A study in Punjab, Haryana and Chandigarh: United Nations Office on Drugs and Crime Regional Office for South Asia, 2012. Report No. 2012.
27. Ambekar A, Tripathi BM. Size estimation of injecting drug use in Punjab & Haryana. UNAIDS: New Delhi; 2008.
28. Jindal N, Arora U, Singh K. Prevalence of human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus in three groups of populations at high risk of HIV infection in Amritsar (Punjab), Northern India. Jpn J Infect Dis. 2008;61(1):79-81.
29. Yardley J. Indian State Finds Itself in Tight Grip of Addiction. In: The New York Times. New York 2012. http://www.webcitation.org/query?url=http%3A%2F%2Fwww.nytimes.com%2F2012%2F04%2F19%2Fworld%2Fasia%2Fdrug-addiction-is-a-growing-problem-in-punjab.html%3F_r%3D1%26pagewanted%3Dall&date=2013-07-24. Accessed 7 Aug 2015
30. Mahanta J, Borkakoty B, Das HK, Chelleng PK. The risk of HIV and HCV infections among injection drug users in northeast India. AIDS Care. 2009;21(11):1420-4.
31. Mahanta J, Medhi GK, Paranjape RS, Roy N, Kohli A, Akoijam BS, et al. Injecting and sexual risk behaviours, sexually transmitted infections and HIV prevalence in injecting drug users in three states in India. AIDS. 2008;22 Suppl 5:S59-68.
32. Solomon SS, Srikrishnan AK, Mehta SH, Vasudevan CK, Murugavel KG, Thamburaj E, et al. High prevalence of HIV, HIV/hepatitis C virus coinfection, and risk behaviors among injection drug users in Chennai, India: a cause for concern. J Acquir Immune Defic Syndr. 2008;49(3):327-32.
33. Safren SA, Martin C, Menon S, Greer J, Solomon S, Mimiaga MJ, et al. A survey of MSM HIV prevention outreach workers in Chennai, India. AIDS Educ Prev. 2006;18(4):323-32.
34. Chakrapani V, Newman PA, Shunmugam M, McLuckie A, Melwin F. Structural violence against Kothi-identified men who have sex with men in Chennai, India: a qualitative investigation. AIDS EducPrev. 2007;19(4):346-64.
35. Latkin C, Srikrishanan A, Yang C, Johnson S, Solomon SS, Kumar S, et al. The relationship between drug use stigma and HIV injection risk behaviors among injection drug users in Chennai, India. Drug Alcohol Depend. 2010;110(3):221-7.
36. World Health Organization UNODC, Joint United Nations Programme on HIV/AIDS. WHO, UNODC, UNAIDS Technical Guide for countries to set targets for universal access to HIV prevention, treatment and care for injecting drug users. 2009. http://www.unodc.org/documents/hiv-aids/idu_target_setting_guide.pdf. Accessed 31 Dec 2014.
37. Coates TJ, Richter L, Caceres C. Behavioural strategies to reduce HIV transmission: how to make them work better. Lancet. 2008;372(9639):669-84.
38. Degenhardt L, Mathers B, Vickerman P, Rhodes T, Latkin C, Hickman M. Prevention of HIV infection for people who inject drugs: why individual, structural, and combination approaches are needed. Lancet.376(9737):285-301
39. Strathdee SA, Hallett TB, Bobrova N, Rhodes T, Booth R, Abdool R, et al. HIV and risk environment for injecting drug users: the past, present, and future. Lancet. 2010;376(9737):268-84.
40. Wolfe D, Carrieri MP, Shepard D. Treatment and care for injecting drug users with HIV infection: a review of barriers and ways forward. Lancet. 2010;376(9738):355-66.
41. Altice FL, Kamarulzaman A, Soriano VV, Schechter M, Friedland GH. Treatment of medical, psychiatric, and substance-use comorbidities in people infected with HIV who use drugs. Lancet. 2010;376(9738):367-87.
42. Beyrer C, Malinowska-Sempruch K, Kamarulzaman A, Kazatchkine M, Sidibe M, Strathdee SA. Time to act: a call for comprehensive responses to HIV in people who use drugs. Lancet. 2010;376(9740):551-63.
43. Aday LA, Andersen R. A framework for the study of access to medical care. Health Serv Res. 1974;9(3):208-20.
44. Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health Soc Behav. 1995;36(1):1-10.
45. Rogers EM. Diffusion of innovations. New York: The Free Press; 1995.
46. Gladwell M. The Tipping Point: How Little Things Can Make a Big Difference. Boston: Little Brown; 2000.
47. Centers for Disease Control and Prevention. Social Networks Testing: A Community-Based Strategy for Identifying Persons with Undiagnosed HIV Infection. Interim Guide for HIV Counseling. 2006. http://www.cdc.gov/hiv/resources/guidelines/snt/. Accessed 31 Dec 2014.
48. Fisher JD, Fisher WA, Misovich SJ, Kimble DL, Malloy TE. Changing AIDS risk behavior: effects of an intervention emphasizing AIDS risk reduction information, motivation, and behavioral skills in a college student population. Health Psychol. 1996;15(2):114-23.
49. Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992;111(3):455-74.
50. Heckathorn D. Respondent-driven sampling: a new approach to the study of hidden populations. Soc Probl. 1997;44(2):174-99.
51. Heckathorn DD. Respondent-driven sampling II: deriving valid population estimates from chain-referral samples of hidden populations. Soc Probl. 2002;49:11-34.
52. Coleman JS. Relational analysis: the study of social organization with survey methods. Hum Org. 1958;17(4):28-36.
53. Hayes RJ, Moulton LH. Cluster Randomised Trials. Chapman & Hall/CRC: Baco Raton, FL; 2009.
54. Wolfinger RD. Covariance structure selection in general mixed models. Commun Stat Simul Comput. 1993;22:1079-106.
55. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38(4):963-74.
56. Rabe-Hesketh S, Skrondal A, Pickles A. Maximum likelihood estimation of limited and discrete dependent variable models with nested random effects. J Econometrics. 2005;128(2):301-23.
57. Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, et al. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012;380(9839):367-77.
58. Beyrer C, Abdool KQ. The changing epidemiology of HIV in 2013. Curr Opin HIV AIDS. 2013;8(4):306-10.
59. Fauci AS. AIDS: let science inform policy. Science. 2011;333(6038):13.
60. De Cock KM, Jaffe HW, Curran JW. Reflections on 30 years of AIDS. Emerg Infect Dis. 2011;17(6):1-11.
61. Saunders JB, Aasland OG, Babor TF, De la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption-II. Addiction. 1993;88(6):791-804.
62. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-13.
63. Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, et al. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008;67(8):1225-35.
64. Solomon SS, Mehta SH, McFall AM, Saravanan S, Laeyendecker O, Balakrishnan P, et al. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016;3(4):e183-190.
65. Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006;28(1):71-7.
66. Group E. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199-208.
67. Chawla A, Murphy G, Donnelly C, Booth CL, Johnson M, Parry JV, et al. Human immunodeficiency virus (HIV) antibody avidity testing to identify recent infection in newly diagnosed HIV type 1 (HIV-1)-seropositive persons infected with diverse HIV-1 subtypes. J Clin Microbiol. 2007;45(2):415-20.
68. Laeyendecker O, Kulich M, Donnell D, Komarek A, Omelka M, Mullis CE, et al. Development of methods for cross-sectional HIV incidence estimation in a large, community randomized trial. PLoS One. 2013;8(11), e78818.
69. Hemelaar J, Gouws E, Ghys PD, Osmanov S. Isolation W-UNfH, Characterisation. Global trends in molecular epidemiology of HIV-1 during 2000-2007. AIDS. 2011;25(5):679-89.