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

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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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Behavioral: MEN Count Behavioral: Comparison

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Actual Study Start Date : March 2013
Primary Completion Date : April 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 stress reduction and healthy lifestyle.
Behavioral: Comparison
general health intervention for men, not inclusive of HIV or relationship health


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. HIV/STI testing [ Time Frame: 6 and 12 month follow-up ]
    HIV and STI testing via blood and urine tests


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694121


Locations
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Anita Raj, PhD UCSD
Principal Investigator: Lisa Bowleg, PhD George Washington University
More Information

Responsible Party: Anita Raj, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01694121     History of Changes
Other Study ID Numbers: R01MH096657 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Anita Raj, University of California, San Diego:
HIV prevention
African American men
evaluation study