Skip to main content
OpenTrials
Completed

NCT Number: NCT02556294

Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The National Institute for Research in Tuberculosis, Chennai, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-acceptance based intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changes in frequency of condomless sex

    Time frame: 4 month visit, 8 month visit, 12, month visit

    Self-reported insertive or receptive anal sex without the use of a condom.

  2. Number of incident STIs from Baseline

    Time frame: 12 month visit

    Chlamydia, gonorrhea, syphilis, and HIV

Secondary outcomes

  1. Changes in Psychosocial Mediators

    Time frame: 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.

  2. Cost-effectiveness of intervention

    Time frame: 12 months

    To assess the incremental cost-effectiveness of the experimental versus the comparison condition.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2015
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.