Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
1 other identifier
interventional
608
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedOctober 23, 2019
October 1, 2019
4.2 years
April 23, 2015
October 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Changes in Psychosocial Mediators
Measured at baseline, 4, 8, 12 month visits
Cost-effectiveness of intervention
12 months
Study Arms (2)
Self-acceptance behavioral intervention
EXPERIMENTALThe 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.
Comparison/Control
OTHERThe comparison group will receive HIV and STI counseling and testing.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participant does not identify as male
- Younger than 18
- Is unable to understand or consent to the procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Institute of Mental Health (NIMH)collaborator
- The National Institute for Research in Tuberculosiscollaborator
- Indian Council of Medical Researchcollaborator
- Sahodarancollaborator
- The Humsafar Trustcollaborator
- Fenway Community Healthcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The National Institute for Research in Tuberculosis
Chennai, India
The Humsafar Trust
Mumbai, India
Related Publications (2)
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.
PMID: 33740407DERIVEDMimiaga 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.
PMID: 30021566DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 23, 2015
First Posted
September 22, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
October 23, 2019
Record last verified: 2019-10