Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

Not Applicable

Completed

• Conditions: Health Behavior; Sexual Behavior; HIV Infection
• Interventions: Behavioral: HIV/STI counseling and testing; Behavioral: Self-acceptance based intervention

• Registration Number: NCT02556294
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-04-23
• Study Start: 2015-06
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 608

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison/Control	HIV/STI counseling and testing	The comparison group will receive HIV and STI counseling and testing.
Self-acceptance behavioral intervention	Self-acceptance based intervention	The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing.
Self-acceptance behavioral intervention	HIV/STI counseling and testing	The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing.

Primary Outcome Measures

Name	Time	Method
Number of incident STIs from Baseline	12 month visit	Chlamydia, gonorrhea, syphilis, and HIV
Changes in frequency of condomless sex	4 month visit, 8 month visit, 12, month visit	Self-reported insertive or receptive anal sex without the use of a condom.

Secondary Outcome Measures

Name	Time	Method
Changes in Psychosocial Mediators	Measured at baseline, 4, 8, 12 month visits	Items will be used to measure potential psychosocial mediators (e.g. self-acceptance questionnaire, distress questionnaire) at each major visit.
Cost-effectiveness of intervention	12 months	To assess the incremental cost-effectiveness of the experimental versus the comparison condition.

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The Humsafar Trust; 🇮🇳 Mumbai, India

The National Institute for Research in Tuberculosis; 🇮🇳 Chennai, India