Expired Study
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Boston, Massachusetts 02114


India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for HIV.

Study summary:

India has the world's third largest HIV epidemic, and MSM in India have an estimated seroprevalence of 14.7%. Many HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of HIV prevention interventions and therefore no evidenced based HIV prevention interventions this population. MSM in India are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which potentially increases the risk for HIV transmission to their wives. This proposal is the culmination of our ongoing, successful > 10-year community based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. Our work, including extensive community advisory input, has identified self-acceptance as a key resilience variable that protects against both HIV risk and psychosocial distress. A field test and pilot randomized controlled trial of our behavioral intervention that addresses both HIV risk and self-acceptance showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior. The current study is a two-arm randomized controlled trial to reduce HIV, STI and sexual transmission risk compared to HIV/STI counseling and testing alone.


Inclusion Criteria - One of the following must be true: - Participant has had anal sex with 4 or more male partners (protected or unprotected) in the past 4 months. - Participant has had condomless anal sex with a man who was HIV unknown or serodiscordant in the past 4 months. - Participant has a history of transactional sex activity in the past 4 months. - Participant has been given a diagnosis of an STI in the past 4 months. Exclusion Criteria: - Participant does not identify as male - Younger than 18 - Is unable to understand or consent to the procedures - Is deemed by the local PI or study staff to be engaging in deception about the inclusion/exclusion criteria.



Primary Contact:

Principal Investigator
Steven A Safren, PhD
University of Miami

Backup Contact:


Location Contact:

Boston, Massachusetts 02114
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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