HIV/STI Incidence, HIV/STI Risk
Conditions
Keywords
HIV, Psychosocial problems, MSM, India
Brief summary
This study will develop and pilot test a combined individual and group-level behavioral HIV prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV risk within the context of broader psychosocial issues, including self-acceptance, substance use and social support.
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.
Interventions
BEHAVIORALBehavioral 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.
Sponsors
National Institute of Mental Health (NIMH)
Tuberculosis Research Centre, India
Fenway Community Health
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant | up to 6 months | We will examine sexual risk taking among the sample using self-report (interviewer administered) measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of STIs - Number of Participants That Acquired STIs | 6 months | We will test for locally relevant STIs at baseline and 6 months. |
| Changes in Psychosocial Mediators | up to 6 months | We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms. |
Countries
India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV/STI Voluntary Counseling and Testing Participants enrolled in the control arm will receive study assessments only. | 48 |
| 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 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. | 48 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 6 |
Baseline characteristics
| Characteristic | HIV/STI Voluntary Counseling and Testing | Behavioral Intervention | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 8.1 | 28.4 years STANDARD_DEVIATION 6.9 | 29 years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 48 Participants | 48 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV/STI Voluntary Counseling and Testing | Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant | 7.58 number of unprotected sex acts | Standard Deviation 1.36 |
| Behavioral Intervention | Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant | 3.69 number of unprotected sex acts | Standard Deviation 0.73 |
Comparison: Intent to treat analysisp-value: <0.00195% CI: [-1.47, -0.44]Mixed Models Analysis
Secondary
Acquisition of STIs - Number of Participants That Acquired STIs
We will test for locally relevant STIs at baseline and 6 months.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV/STI Voluntary Counseling and Testing | Acquisition of STIs - Number of Participants That Acquired STIs | 14 participants |
| Behavioral Intervention | Acquisition of STIs - Number of Participants That Acquired STIs | 8 participants |
Comparison: Intent to treat analysis.p-value: =0.239Chi-squared
Secondary
Changes in Psychosocial Mediators
We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
Time frame: up to 6 months