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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 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 396 participants.

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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.

Interventions

  • BEHAVIORAL Bruthas Project
  • BEHAVIORAL Standard HIV Testing and Counseling

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2011-02
Est. Completion 2016-08
Phase Phase 2

What the Registry Record Tells You About NCT01270230

The ClinicalTrials.gov registry entry for NCT01270230 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Bruthas Project is the first listed.

NCT01270230 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.