- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266122
Addressing Psychosocial Needs and HIV Risk in Indian MSM
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India
- Tuberculosis Research Centre
-
-
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Fenway Community Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man who has had unprotected sex with another man in past 3 months
- Resident of Tamil Nadu state, India
- Identifies as Khothi or Double-decker
Exclusion Criteria:
- Does not identify as a man (i.e. Hijra/ Ali/Transgendered)
- Under age 18
- Unable to complete or understand informed consent procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven A. Safren, PhD, Massachusetts General Hospital, Boston, Massachusetts, United States
- Principal Investigator: Beena E. Thomas, PhD, Tuberculosis Research Centre, Chennai, India
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5R21MH085314-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV/STI Risk
-
Kirby InstituteCompleted
-
Fundació Institut Germans Trias i PujolHospital Vall d'Hebron; Department of Health, Generalitat de CatalunyaNot yet recruiting
-
University of ConnecticutNational Institute of Mental Health (NIMH)Completed
-
Yale UniversityCompletedHIV Prevention | STI PreventionUnited States
-
University of WashingtonTasso Inc.RecruitingHIV Prevention | STI | Pre-exposure ProphylaxisUnited States
-
Emory UniversityNational Institute of Mental Health (NIMH)Recruiting
-
ANRS, Emerging Infectious DiseasesRecruiting
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); Centers for Disease Control and...CompletedHIV | Mental Disorder | STI | Emotional DisturbancesUnited States
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH)Active, not recruitingHIV Prevention | Self Efficacy | STI PreventionUnited States
-
Massachusetts General HospitalNational Institute of Allergy and Infectious Diseases (NIAID); AIDS Healthcare...RecruitingSTI | Contraceptive Usage | Pre-Exposure ProphylaxisSouth Africa
Clinical Trials on Behavioral intervention
-
M.D. Anderson Cancer CenterActive, not recruitingObesity-Related Malignant NeoplasmUnited States
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brown... and other collaboratorsRecruiting
-
VA Office of Research and DevelopmentCompleted
-
National Taiwan University HospitalUnknown
-
VA Office of Research and DevelopmentRecruiting
-
Pennington Biomedical Research CenterThe Coca-Cola CompanyCompletedParent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)Physical ActivityUnited States
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
New York State Psychiatric InstituteCompletedPostpartum DepressionUnited States
-
Roswell Park Cancer InstituteRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States