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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 is a Phase 2 study that has completed, run by Public Health Management Corporation. The registered enrollment target is 169 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01347164
The ClinicalTrials.gov registry entry for NCT01347164 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Public Health Management Corporation, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RISE life coaching intervention is the first listed.
NCT01347164 reports 0 study locations.
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.
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