Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MEN Count)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01694121
First received: September 22, 2012
Last updated: October 16, 2012
Last verified: October 2012

September 22, 2012
October 16, 2012
March 2013
May 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01694121 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • 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
  • 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.
    Intervention: Behavioral: MEN Count
  • 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.
    Intervention: Behavioral: Comparison
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
504
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact: Anita Raj, PhD 858-822-0229 anitaraj@ucsd.edu
United States
 
NCT01694121
R01MH096657
Yes
Anita Raj, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Anita Raj, PhD UCSD
Principal Investigator: Lisa Bowleg, PhD Drexel University
University of California, San Diego
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP