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

NCT01694121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2018-12-28

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

MEN Count

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.

BEHAVIORAL

Comparison

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

Sponsors & Collaborators

Principal Investigators

  • Anita Raj, PhD · UCSD

  • Lisa Bowleg, PhD · George Washington University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-04-30
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694121 on ClinicalTrials.gov