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Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556294
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
The National Institute for Research in Tuberculosis
Indian Council of Medical Research
Sahodaran
The Humsafar Trust
Fenway Community Health
Information provided by (Responsible Party):
Steven A. Safren, 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.

Condition or disease Intervention/treatment Phase
HIV Infection Sexual Behavior Health Behavior Behavioral: Self-acceptance based intervention Behavioral: HIV/STI counseling and testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Self-acceptance behavioral 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.
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.

Comparison/Control
The comparison group will receive HIV and STI counseling and testing.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556294


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
India
The National Institute for Research in Tuberculosis
Chennai, India
The Humsafar Trust
Mumbai, India
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
The National Institute for Research in Tuberculosis
Indian Council of Medical Research
Sahodaran
The Humsafar Trust
Fenway Community Health
Investigators
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Principal Investigator: Steven A Safren, PhD University of Miami
Principal Investigator: Matthew J Mimiaga, ScD, MPH Brown University
Principal Investigator: Conall M O'Cleirigh, Ph.D. Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steven A. Safren, Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02556294    
Other Study ID Numbers: R01MH100627-01A1 ( U.S. NIH Grant/Contract )
R01MH100627-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by Steven A. Safren, Massachusetts General Hospital:
HIV risk behavior
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases