Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

HIV Infection Clinical Trial

Official title:

Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556294
• Other study ID #: R01MH100627-01A1
• Secondary ID: R01MH100627-01A1
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• HIV Infection
• HIV Infections
• Sexual Behavior

Intervention

Behavioral:
• Self-acceptance based intervention
The intervention will consist of HIV/STI counseling and testing as well as individual counseling sessions and group sessions. The primary focus of the group sessions are to help foster self-acceptance by the support from the group, as well as learn skills to reduce distress and HIV risk. The primary purpose of the individual sessions is to help develop and implement an individualized plan for HIV risk reduction, and, as needed and available, linkage to other services.
• HIV/STI counseling and testing
The counseling component is standard of care in India and will focus on HIV/STI risk and how to minimize risk. This is followed by biological testing for HIV and STIs.

Locations

Country	Name	City	State
India	The National Institute for Research in Tuberculosis	Chennai
India	The Humsafar Trust	Mumbai
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Fenway Community Health, Indian Council of Medical Research, National Institute of Mental Health (NIMH), Sahodaran, The Humsafar Trust, The National Institute for Research in Tuberculosis

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of condomless sex	Self-reported insertive or receptive anal sex without the use of a condom.	4 month visit, 8 month visit, 12, month visit
Primary	Number of incident STIs from Baseline	Chlamydia, gonorrhea, syphilis, and HIV	12 month visit
Secondary	Changes in Psychosocial Mediators	Items will be used to measure potential psychosocial mediators (e.g. self-acceptance questionnaire, distress questionnaire) at each major visit.	Measured at baseline, 4, 8, 12 month visits
Secondary	Cost-effectiveness of intervention	To assess the incremental cost-effectiveness of the experimental versus the comparison condition.	12 months