Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MEN Count)
The purpose of this study is to evaluate the efficacy of the 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 CBPR approach via funding from an NIH R21, in Boston, MA. A more rigorous evaluation design (i.e., a randomized controlled trial- RCT) will be used to test MEN Count in an employment training community service agency for Black men 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 RCT will be conducted in which participants will be randomized to 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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men|
- condom use [ Time Frame: up to 12 month follow-up ] [ Designated as safety issue: No ]behavioral assessment of the ratio of protected to total number of sex episodes
- HIV/STI testing [ Time Frame: 6 and 12 month follow-up ] [ Designated as safety issue: No ]HIV and STI testing via blood and urine tests
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: MEN Count
3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.
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.
Active Comparator: Comparison
An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on general men's health- nutrition, exercise and primary health care utilization.
general health intervention for men, not inclusive of HIV or relationship health
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694121
|Contact: Anita Raj, PhDfirstname.lastname@example.org|
|United States, District of Columbia|
|George Washington University||Recruiting|
|Washington DC, District of Columbia, United States, 20052|
|Contact: Lisa Bowleg, PhD 202-994-1000 email@example.com|
|Principal Investigator: Lisa Bowleg, PhD|
|Principal Investigator:||Anita Raj, PhD||UCSD|
|Principal Investigator:||Lisa Bowleg, PhD||George Washington University|