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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694121

Contacts
Contact: Anita Raj, PhD 858-822-0229 anitaraj@ucsd.edu

Locations
United States, Pennsylvania
Drexel University Not yet recruiting
Philadelpha, Pennsylvania, United States, 19104
Contact: Lisa Bowleg, PhD       iab@drexel.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Anita Raj, PhD UCSD
Principal Investigator: Lisa Bowleg, PhD Drexel University
  More Information

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 August 19, 2014