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NCT01641146 · ClinicalTrials.gov registry record · Phase 2
An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)
A Phase 2 study of Depression and HIV, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 4
- Study locations
NCT01641146 is a Phase 2 study of Depression and HIV that has completed, run by University of California, Los Angeles. The registered enrollment target is 118 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT01641146, a Phase 2 study of Depression and HIV, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 4
- Study locations
Study Summary
HIV continues to spread among Black men who have sex with men (MSM), but few interventions target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular, neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS progression. The purpose of this study was to test an HIV risk reduction intervention, guided by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a composite of the cumulative effects of stress on biological systems including psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected anal and vaginal sex and number of sex partners) and negative psychological symptoms of depression and PTSD. Links between these outcomes and biomarkers of stress were also explored. Randomization to either the ES-HIM or a health promotion control group occurred with study participants assessed at baseline, post, 3- and 6-months.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Sexual Health Intervention for Men (ES-HIM)
- BEHAVIORAL Health Promotion (HP) Comparison Arm
Study Locations (4)
California
- The AmASSI Health and Cultural Center - Inglewood
- Palms Residential Care Facility - Los Angeles
- University of California, Los Angeles (UCLA) - Los Angeles
- JWCH Institute Inc. - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641146
The ClinicalTrials.gov registry entry for NCT01641146 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (85% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Sexual Health Intervention for Men (ES-HIM) is the first listed.
NCT01641146 reports 4 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01641146 about?
NCT01641146 is a clinical study titled "An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)". HIV continues to spread among Black men who have sex with men (MSM), but few interventions target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk sexual behaviors; b) ne...
What is the current status of trial NCT01641146?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2008-12. Estimated completion is 2011-05.
What conditions does trial NCT01641146 study?
This clinical trial studies the following conditions: Depression, HIV, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT01641146?
The interventions under investigation include: Enhanced Sexual Health Intervention for Men (ES-HIM) (BEHAVIORAL), Health Promotion (HP) Comparison Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT01641146?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01641146 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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