Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MEN Count)
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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. Similar CBPR methods accompanied by 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 Philadelphia (NCCF). Study participants (N=504) will be Black men reporting heterosexual risk for HIV [unprotected sex with a woman in the past 30 days 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 but focused on general men's health- nutrition, exercise and primary health care utilization. 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.
Condition | Intervention |
---|---|
HIV |
Behavioral: MEN Count Behavioral: Comparison |
Study Type: | Interventional |
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
Estimated Enrollment: | 504 |
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) |
Arms | Assigned Interventions |
---|---|
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.
|
Behavioral: Comparison
general health intervention for men, not inclusive of HIV or relationship health
|
![](https://webarchive.library.unt.edu/web/20130317080518im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman in the past 30 days and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Exclusion Criteria:
- Active injection drug use
![](https://webarchive.library.unt.edu/web/20130317080518im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Anita Raj, PhD | 858-822-0229 | anitaraj@ucsd.edu |
United States, Pennsylvania | |
Drexel University | Not yet recruiting |
Philadelpha, Pennsylvania, United States, 19104 | |
Contact: Lisa Bowleg, PhD iab@drexel.edu |
Principal Investigator: | Anita Raj, PhD | UCSD |
Principal Investigator: | Lisa Bowleg, PhD | Drexel University |
![](https://webarchive.library.unt.edu/web/20130317080518im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Anita Raj, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01694121 History of Changes |
Other Study ID Numbers: | R01MH096657 |
Study First Received: | September 22, 2012 |
Last Updated: | October 16, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
HIV prevention African American men evaluation study |
ClinicalTrials.gov processed this record on March 14, 2013