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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21MH085314-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Tuberculosis Research Centre, India | OTHER_GOV |
| Fenway Community Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV/STI voluntary counseling and testing | No Intervention | Participants enrolled in the control arm will receive study assessments only. | |
| Behavioral intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acquisition of STIs - Number of Participants That Acquired STIs | We will test for locally relevant STIs at baseline and 6 months. | 6 months |
| Changes in Psychosocial Mediators | We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A. Safren, PhD | Massachusetts General Hospital, Boston, Massachusetts, United States | Principal Investigator |
| Beena E. Thomas, PhD | Tuberculosis Research Centre, Chennai, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Fenway Community Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30993478 | Derived | O'Cleirigh C, Safren SA, Taylor SW, Goshe BM, Bedoya CA, Marquez SM, Boroughs MS, Shipherd JC. Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial. AIDS Behav. 2019 Sep;23(9):2421-2431. doi: 10.1007/s10461-019-02482-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV/STI Voluntary Counseling and Testing | Participants enrolled in the control arm will receive study assessments only. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV/STI Voluntary Counseling and Testing | Participants enrolled in the control arm will receive study assessments only. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | number of unprotected sex acts | up to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV/STI Voluntary Counseling and Testing | Participants enrolled in the control arm will receive study assessments only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Safren | Behavioral Medicine Service, Massachusetts General Hospital | 617-724-0817 | ssafren@partners.org |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D000083626 | Psychosocial Intervention |
| C025910 | dimethyl sulfone |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| up to 6 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Tuberculosis Research Centre | Chennai | Tamil Nadu | India |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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|
|
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| Secondary | Acquisition of STIs - Number of Participants That Acquired STIs | We will test for locally relevant STIs at baseline and 6 months. | Posted | Number | participants | 6 months |
|
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|
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| Secondary | Changes in Psychosocial Mediators | We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms. | Not Posted | up to 6 months |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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. | 0 | 48 | 0 | 48 |
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