Addressing Psychosocial Needs and HIV Risk in Indian MSM

Study Overview
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Brief Summary
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This study will develop and pilot test a combined individual and group-level behavioral HIV prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV risk within the context of broader psychosocial issues, including self-acceptance, substance use and social support.

Detailed Description
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MSM in India are at increased risk for HIV in a stigmatizing environment that includes discrimination and violence. There is a need for evidence-based MSM HIV prevention interventions that address HIV risk in the context of these psychosocial issues. This study consists of formative qualitative work followed by the development and testing of a pilot behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to maximize intervention feasibility and acceptability, estimate an effect size for a power analysis, and prepare for a full-scale trial to follow. PHASE 1-Intervention Development. This phase involved the collection of formative data through MSM focus groups and key informant interviews to develop a subsequent pilot behavioral intervention. PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot of the intervention. Enrollment involved a baseline assessment that included an interviewer-administered behavioral assessment and voluntary counseling and testing for HIV and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6 group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment was administered upon completion of all sessions, and 6 months after baseline participants were again administered the questionnaire and HIV/STI testing. PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data articulated in this registry is for Phase 3. We are now conducting a pilot randomized controlled trial (RCT) of the intervention among 6 batches of 8 MSM in each group (n=48). Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI counseling and testing as the intervention groups. Based on Phase 2 findings, the intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned to receive the comparison condition will not receive these sessions. Participants complete the assessments approximately 3 months after randomization, and again 3 months after that.

Official Title
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Addressing Psychosocial Needs and HIV Risk in Indian MSM

Conditions
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HIV/STI Risk, HIV/STI Incidence

Intervention / Treatment
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* Behavioral: Behavioral intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man who has had unprotected sex with another man in past 3 months Resident of Tamil Nadu state, India Identifies as Khothi or Double-decker Exclusion Criteria: Does not identify as a man (i.e. Hijra/ Ali/Transgendered) Under age 18 Unable to complete or understand informed consent procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: HIV/STI voluntary counseling and testing<br>Participants enrolled in the control arm will receive study assessments only. | |
| Experimental: Behavioral intervention<br>Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India. | Behavioral: Behavioral intervention<br>* The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk.<br>* Other names: Psychosocial intervention for MSM in India;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant | We will examine sexual risk taking among the sample using self-report (interviewer administered) measures. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition of STIs - Number of Participants That Acquired STIs | We will test for locally relevant STIs at baseline and 6 months. | 6 months | 
| Changes in Psychosocial Mediators | We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Psychosocial problems, MSM, India