A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India: study protocol

Matthew J Mimiaga, Beena Thomas, Kenneth H Mayer, Kristen S Regenauer, Alpana Dange, C Andres Bedoya, Shruta Rawat, Vinoth Balu, Conall O'Cleirigh, Katie B Biello, Vivek Anand, Soumya Swaminathan, Steven A Safren, Matthew J Mimiaga, Beena Thomas, Kenneth H Mayer, Kristen S Regenauer, Alpana Dange, C Andres Bedoya, Shruta Rawat, Vinoth Balu, Conall O'Cleirigh, Katie B Biello, Vivek Anand, Soumya Swaminathan, Steven A Safren

Abstract

Background: Men who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India.

Methods: Funded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months.

Discussion: HIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group.

Trial registration: ClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

Keywords: HIV prevention; India; MSM; Psychosocial intervention; Randomized controlled trial; STI prevention; Self-acceptance.

Conflict of interest statement

Ethics approval and consent to participate

This protocol has been approved by the Institutional Review Boards at Massachusetts General Hospital (Partners Human Research Committee) in Boston, Massachusetts, USA, The Humsafar Trust (HST IRB) in Mumbai, India, and The National Institute for Research in Tuberculosis (Institutional Ethics Committee) in Chennai, India. The protocol was also approved by the Indian Council of Medical Research (ICMR). All participants must complete informed consent procedures to participate.

Consent for publication

Not applicable.

Competing interests

Dr. Katie Biello is an Associate Editor for BMC Public Health. All other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study intervention process

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