Clinical trial NCT01694121: Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Official title: Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV prevention
African American men
evaluation study
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 455
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
timeFrame: 12 month follow-up
measure: Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Non-viral STI - 12 Month Follow-up
timeFrame: 12 month follow-up
measure: Non-viral STI - 6 Month Follow-up
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: UCSD
name: Anita Raj, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Lisa Bowleg, PhD
role: PRINCIPAL_INVESTIGATOR
References: