We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01694121
Recruitment Status : Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):

September 22, 2012
September 26, 2012
November 24, 2017
March 2013
April 2017   (Final data collection date for primary outcome measure)
condom use/unprotected sex [ Time Frame: up to 12 month follow-up ]
behavioral assessment of the ratio of protected to total number of sex episodes
condom use [ Time Frame: up to 12 month follow-up ]
behavioral assessment of the ratio of protected to total number of sex episodes
Complete list of historical versions of study NCT01694121 on ClinicalTrials.gov Archive Site
HIV/STI testing [ Time Frame: 6 and 12 month follow-up ]
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 effectiveness 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 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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 stress reduction and healthy lifestyle.
    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.
 
Active, not recruiting
455
May 2018
April 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 and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01694121
R01MH096657( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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 George Washington University
University of California, San Diego
November 2017

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