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

• 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: University of California, San Diego
• Information provided by (Responsible Party): Anita Raj, University of California, San Diego

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: MEN Count; Behavioral: Comparison	Not Applicable

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
• Actual Primary Completion Date: April 2017
• Actual Study Completion Date: May 2018

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 - 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.
2. 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.

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• 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.

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

Contacts and Locations

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

  Study Documents (Full-Text)

Documents provided by Anita Raj, University of California, San Diego:

Study Protocol and Statistical Analysis Plan  [PDF] May 29, 2018

Informed Consent Form  [PDF] February 10, 2015

More Information

• Responsible Party: Anita Raj, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01694121
• Other Study ID Numbers: R01MH096657 ( U.S. NIH Grant/Contract )
• First Posted: September 26, 2012
• Results First Posted: December 28, 2018
• Last Update Posted: December 28, 2018
• Last Verified: December 2018

Keywords provided by Anita Raj, University of California, San Diego:

HIV prevention; African American men; evaluation study