Clinical trial NCT02556294: Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
Official title: Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Sexual Behavior
Health Behavior
Keywords: HIV risk behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: The National Institute for Research in Tuberculosis
name: Indian Council of Medical Research
name: Sahodaran
name: The Humsafar Trust
name: Fenway Community Health
First posted: 2015-09-22
Enrollment: 608
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in frequency of condomless sex
timeFrame: 4 month visit, 8 month visit, 12, month visit
measure: Number of incident STIs from Baseline
timeFrame: 12 month visit
Secondary outcomes:
measure: Changes in Psychosocial Mediators
timeFrame: Measured at baseline, 4, 8, 12 month visits
measure: Cost-effectiveness of intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Chennai
country: India
facility: The National Institute for Research in Tuberculosis
city: Mumbai
country: India
facility: The Humsafar Trust
Study officials:
affiliation: University of Miami
name: Steven A Safren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Matthew J Mimiaga, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Conall M O'Cleirigh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.