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

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ClinicalTrials.gov Identifier: NCT01694121
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego

September 22, 2012
September 26, 2012
November 14, 2018
December 28, 2018
December 28, 2018
March 2013
April 2017   (Final data collection date for primary outcome measure)
  • Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up [ Time Frame: 12 month follow-up ]
    Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
  • Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up [ Time Frame: 6 month follow-up ]
    Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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
  • Non-viral STI - 12 Month Follow-up [ Time Frame: 12 month follow-up ]
    HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
  • Non-viral STI - 6 Month Follow-up [ Time Frame: 6 month follow-up ]
    HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
HIV/STI testing [ Time Frame: 6 and 12 month follow-up ]
HIV and STI testing via blood and urine tests
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 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.
Not Provided
Interventional
Not Applicable
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.
 
Completed
455
504
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.

Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program

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
December 2018

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