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NCT01347164 · ClinicalTrials.gov registry record · Phase 2
Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men
A Phase 2 study, sponsored by Public Health Management Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT01347164: Completed Phase 2 study, sponsored by Public Health Management Corporation.
NCT01347164 is a Phase 2 study that has completed, run by Public Health Management Corporation. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01347164, a Phase 2 study, has completed, sponsored by Public Health Management Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
Black men who have sex with men (MSM) have the highest rates of HIV infection in the United States and represent a population in need of new HIV prevention interventions. Although 20 to 40% of Black MSM are estimated to have female partners, no interventions tailored to the needs of Black MSM/W have been developed and rigorously evaluated. This project will develop, implement, and evaluate an individual-level intervention (ILI), titled "RISE", that will assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection. This intervention will address the effect of individual level factors, interpersonal relationships including sexual, peer and family relationships, and socio-cultural influences on the sexual risk behaviors of MSM/W. The intervention will consist of six counseling sessions held between a trained counselor and participant, and will be guided by three theoretical perspectives: an ecological perspective of behavior, stress and coping theory, and social cognitive theory. The COLOURS Organization, the sole agency in Philadelphia dedicated to exclusively serving the Black LGBT community, will be a key collaborator in the development and implementation of the intervention. The evaluation design utilizes a randomized controlled trial to test the effectiveness of the proposed intervention. Chain referral, based on principles of respondent-driven sampling, will be used to recruit 250 HIV-positive and HIV-negative Black bisexually-active men into this study. The specific aims of this research are to: * develop a new theoretically-based individual-level HIV prevention intervention culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W; * evaluate the intervention with a randomized control group design, using RDS to recruit 250 Black MSM/W who do not inject drugs and who report recent unprotected sex; * assess the efficacy of the intervention and test the intervention model through the collection of behavioral risk asses
Interventions
- BEHAVIORAL RISE life coaching intervention
- BEHAVIORAL HIV Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01347164 record still lists
NCT01347164 is an interventional study that assigns participants to a tested intervention. The registered 169 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 (27% higher).
The record links to 0 conditions, and to 2 interventions - of which RISE life coaching intervention is the first listed.
NCT01347164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01347164 about?
NCT01347164 is a clinical study titled "Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men". Black men who have sex with men (MSM) have the highest rates of HIV infection in the United States and represent a population in need of new HIV prevention interventions. Although 20 to 40% of Black MSM are estimated to have female partners, no interventions tailored to the needs of Black MSM/W have...
What is the current status of trial NCT01347164?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2010-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01347164?
The interventions under investigation include: RISE life coaching intervention (BEHAVIORAL), HIV Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01347164?
This trial is sponsored by Public Health Management Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01347164's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 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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