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

NCT01694121 | Completed Results DMC

• 1 other identifier: R01MH096657
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV prevention; African American men; evaluation study

Outcome Measures

Primary Outcomes (2)

• Condom Use/Unprotected Sex - Redefined as Sexual Risk - 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.

  12 month follow-up

• Condom Use/Unprotected Sex - Redefined as Sexual Risk - 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.

  6 month follow-up

Secondary Outcomes (2)

• Non-viral STI - 12 Month Follow-up

  12 month follow-up

• Non-viral STI - 6 Month Follow-up

  6 month follow-up

Study Arms (2)

MEN Count

EXPERIMENTAL

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

Comparison

ACTIVE COMPARATOR

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

Interventions

MEN Count BEHAVIORAL

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

Comparison BEHAVIORAL

general health intervention for men, not inclusive of HIV or relationship health

Comparison

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Results Point of Contact

• Title: Dr. Anita Raj
• Organization: Center on Gender Equity and Health at UCSD

anitaraj@ucsd.edu

8588220229

Study Officials

• Anita Raj, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

• Lisa Bowleg, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: September 26, 2012
• Study Start: March 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2018
• Last Updated: December 28, 2018
• Results First Posted: December 28, 2018

Record last verified: 2018-12

Locations

US (1)