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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 608
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chennai, India
    • The National Institute for Research in Tuberculosis
  • Mumbai, India
    • The Humsafar Trust
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of incident STIs from Baseline	Chlamydia, gonorrhea, syphilis, and HIV	12 month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cost-effectiveness of intervention	To assess the incremental cost-effectiveness of the experimental versus the comparison condition.	12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH); Indian Council of Medical Research; Fenway Community Health; The Humsafar Trust; The National Institute for Research in Tuberculosis; Sahodaran
• Investigators: Principal Investigator: Matthew J Mimiaga, ScD, MPH, Brown University; Principal Investigator: Conall M O'Cleirigh, Ph.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• Safren SA, Thomas B, Biello KB, Mayer KH, Rawat S, Dange A, Bedoya CA, Menon S, Anand V, Balu V, O'Cleirigh C, Klasko-Foster L, Baruah D, Swaminathan S, Mimiaga MJ. Strengthening resilience to reduce HIV risk in Indian MSM: a multicity, randomised, clinical efficacy trial. Lancet Glob Health. 2021 Apr;9(4):e446-e455. doi: 10.1016/S2214-109X(20)30547-7.
• Mimiaga MJ, Thomas B, Mayer KH, Regenauer KS, Dange A, Andres Bedoya C, Rawat S, Balu V, O'Cleirigh C, Biello KB, Anand V, Swaminathan S, Safren SA. A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India: study protocol. BMC Public Health. 2018 Jul 18;18(1):890. doi: 10.1186/s12889-018-5838-2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: HIV risk behavior
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: R01MH100627-01A1 (U.S. NIH Grant/Contract)