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NCT01270230 · ClinicalTrials.gov registry record · Phase 2
A Randomized Controlled Trial of the Bruthas Project
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 396
- Enrollment target
NCT01270230: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01270230 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 396 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (198% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01270230, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 396 participants
- Enrollment target
Study Summary
African American men who have sex with men and women (AAMSMW) are at particular risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Despite the urgent need for effective prevention approaches for AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested for this population. This study is a randomized controlled trial of the Bruthas Project(BP), an individual-level HIV prevention intervention, which builds on standardized HIV counseling and testing. Delivered in a series of four sessions by trained African American male counselors, the BP focuses on reviewing HIV transmission routes for male and female partners, strengthening sexual communication skills with both male and female partners, and improving condom use skills and other safer sex negotiation strategies. A randomized controlled trial of BP is necessary to determine the efficacy of the intervention and can lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the African American community more generally. To evaluate the effect of the BP, the investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned to either the intervention condition, in which they will be offered BP, or to the comparison condition, in which they will receive standardized HIV testing and counseling with referral to case management. The investigators will follow the cohort over 9 months and will assess participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.
Primary Outcome
Our primary outcome measure will feature two approaches to assessing HIV risk: we will assess (a) general sexual risk behaviors during the past 3 months and (b) event-level characteristics of sexual risk episodes for the past 1 month. Participants will report on general sexual activity during the past 3 months, including insertive vaginal sex, insertive/receptive anal sex, and giving/receiving oral sex. They will report on overall number of episodes, number of unprotected episodes, and episodes
Interventions
- BEHAVIORAL Bruthas Project
- BEHAVIORAL Standard HIV Testing and Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2011-02 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT01270230 record still lists
NCT01270230 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (198% higher).
The record links to 0 conditions, and to 2 interventions - of which Bruthas Project is the first listed.
NCT01270230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01270230 about?
NCT01270230 is a clinical study titled "A Randomized Controlled Trial of the Bruthas Project". African American men who have sex with men and women (AAMSMW) are at particular risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Despite the urgent need for effective prevention approaches for AAMSMW, to our knowledge no evidence-...
What is the current status of trial NCT01270230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2011-02. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01270230?
The interventions under investigation include: Bruthas Project (BEHAVIORAL), Standard HIV Testing and Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01270230?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01270230's enrollment target sits among peer trials
396 103rd of 2000 higher than 1,898 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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