Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

NCT02556294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2019-10-23

No results posted yet for this study

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.

Conditions

  • HIV Infection
  • Sexual Behavior
  • Health Behavior

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • The National Institute for Research in Tuberculosis

    collaborator UNKNOWN
  • Indian Council of Medical Research

    collaborator OTHER_GOV
  • Sahodaran

    collaborator UNKNOWN
  • The Humsafar Trust

    collaborator UNKNOWN
  • Fenway Community Health

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Steven A Safren, PhD · University of Miami

  • Matthew J Mimiaga, ScD, MPH · Brown University

  • Conall M O'Cleirigh, Ph.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556294 on ClinicalTrials.gov