Addressing Psychosocial Needs and HIV Risk in Indian MSM
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|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.
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): 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|