CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 455 enrolled
Drug / intervention
MEN Count +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01694121
NCT01694121N/ACompleted

Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men

University of California, San Diego·interventional·Posted Sep 26, 2012·Updated Dec 28, 2018

In Brief

A clinical study evaluating MEN Count and Comparison for HIV. Completed, enrolled 455 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2012
Enrollment StartMar 1, 2013
Primary CompletionApr 1, 2017
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.8 years ago

Interventions

MEN Countbehavioral

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.

Comparisonbehavioral

general health intervention for men, not inclusive of HIV or relationship health