Addressing Psychosocial Needs and HIV Risk in Indian MSM
|ClinicalTrials.gov Identifier: NCT01266122|
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV/STI Risk HIV/STI Incidence||Behavioral: Behavioral intervention||Not Applicable|
MSM in India are at increased risk for HIV in a stigmatizing environment that includes discrimination and violence. There is a need for evidence-based MSM HIV prevention interventions that address HIV risk in the context of these psychosocial issues. This study consists of formative qualitative work followed by the development and testing of a pilot behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to maximize intervention feasibility and acceptability, estimate an effect size for a power analysis, and prepare for a full-scale trial to follow.
PHASE 1-Intervention Development. This phase involved the collection of formative data through MSM focus groups and key informant interviews to develop a subsequent pilot behavioral intervention.
PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot of the intervention. Enrollment involved a baseline assessment that included an interviewer-administered behavioral assessment and voluntary counseling and testing for HIV and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6 group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment was administered upon completion of all sessions, and 6 months after baseline participants were again administered the questionnaire and HIV/STI testing.
PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data articulated in this registry is for Phase 3. We are now conducting a pilot randomized controlled trial (RCT) of the intervention among 6 "batches" of 8 MSM in each group (n=48). Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI counseling and testing as the intervention groups. Based on Phase 2 findings, the intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned to receive the comparison condition will not receive these sessions. Participants complete the assessments approximately 3 months after randomization, and again 3 months after that.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Addressing Psychosocial Needs and HIV Risk in Indian MSM|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
No Intervention: HIV/STI voluntary counseling and testing
Participants enrolled in the control arm will receive study assessments only.
Experimental: Behavioral intervention
Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral: Behavioral intervention
The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk.
Other Name: Psychosocial intervention for MSM in India
- Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant [ Time Frame: up to 6 months ]We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
- Acquisition of STIs - Number of Participants That Acquired STIs [ Time Frame: 6 months ]We will test for locally relevant STIs at baseline and 6 months.
- Changes in Psychosocial Mediators [ Time Frame: up to 6 months ]We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266122
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Fenway Community Health|
|Boston, Massachusetts, United States, 02215|
|Tuberculosis Research Centre|
|Chennai, Tamil Nadu, India|
|Principal Investigator:||Steven A. Safren, PhD||Massachusetts General Hospital, Boston, Massachusetts, United States|
|Principal Investigator:||Beena E. Thomas, PhD||Tuberculosis Research Centre, Chennai, India|