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NCT01694121 · ClinicalTrials.gov registry record · NA
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 455
- Enrollment target
NCT01694121: Completed NA study, sponsored by University of California, San Diego.
NCT01694121 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 455 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01694121, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of the Making Employment Needs (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. MEN Count was developed and pilot tested using a Community-based participatory research (CBPR) approach via funding from a National Institutes of Health (NIH) R21, in Boston, Massachusetts. A more larger scale, two-armed quasi-experimental controlled trial design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic and other community-recruitment methods in Washington, DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV \[unprotected sex with a woman and 2+ female sex partners in the past 6 months\] and either current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design will be conducted in which participants will receive either MEN Count or an attention comparison program similar to MEN Count in structure. We will assess program impact on reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted to ensure high quality program adherence and delivery, as well as to support program replication should the model prove effective.
Primary Outcome
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condo
Interventions
- BEHAVIORAL Comparison
- BEHAVIORAL MEN Count
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-05 |
| Phase | NA |
What the finished NCT01694121 record still lists
NCT01694121 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Comparison is the first listed.
NCT01694121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01694121 about?
NCT01694121 is a clinical study titled "Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men". The purpose of this study is to evaluate the effectiveness of the Making Employment Needs (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case m...
What is the current status of trial NCT01694121?
This trial is currently completed. It is a NA study. The enrollment target is 455 participants. The study started on 2013-03. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01694121?
The interventions under investigation include: Comparison (BEHAVIORAL), MEN Count (BEHAVIORAL).
Who is sponsoring clinical trial NCT01694121?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01694121's enrollment target sits among peer trials
455 224th of 2000 higher than 1,777 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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