Clinical trial NCT01492530: Men of African American Legacy Empowering Self
Official title: Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: Men who have sex with Men and Women
HIV Prevention
Behavioral Intervention
Condom use
African American MSMW
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: California HIV/AIDS Research Program
name: University of California, Los Angeles
First posted: 2011-12-15
Enrollment: 437
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The MAALES Project is a community collaborative intervention designed to prevent HIV infection and transmission among African American men who have sex with both men and women. The investigators are a collaboration of researchers, community service providers and activists who are committed to developing and testing effective HIV prevention interventions that employ holistic and culturally relevant approaches. This includes recognizing the impact of forces such as racism, homophobia, heterosexism, sexism, and gender expectations on individual behavior and relationship dynamics in African American communities.

Detailed description: HIV directly or indirectly related to male-to-male sexual intercourse is the largest contributor to HIV infection among Blacks (CDC 2002), accounting for approximately half of all US AIDS cases diagnosed among Black men and a substantial but unknown portion of cases diagnosed among Black women in 2001 (CDC 2002). The Men of African American Legacy Empowering Self (MAALES) Project is an intervention, designed to reduce HIV risk-related behaviors among African American men who have sex with men and women (MSMW) in Los Angeles.

We propose to test the efficacy of the Men of African American Legacy Empowering Self (MAALES) Project, a newly developed, novel, and culturally congruent intervention designed to reduce HIV risk-related behaviors and improve psychosocial outcomes. The MAALES intervention, which originally pilot tested with 50 men using funds from the University of California's University wide AIDS Research Program (UARP), is guided by the Theory of Reasoned Action and Planned Behavior (9; 10), the Critical Thinking and Cultural Affirmation (CTCA) Model developed by a collaborating community-based organization (11), and the Empowerment Theory (12). The small group MAALES intervention was developed through an extensive formative research process and involves six two-hour group sessions held over three weeks and lead by two ethnically matched co-facilitators. In the proposed study, we will conduct a Phase 2a test of an enhanced version of the intervention with a total of 350-400 MSMW, evenly randomized to intervention and wait listed control conditions. The enhanced intervention includes two booster sessions conducted at 1.5- and 4.5-months post conclusion of the six sessions and dialogues regarding assumptions about prospective partners' HIV serostatus. Post-intervention survey assessments will occur immediately (for psychosocial outcomes and mediators) and at three and six months post conclusion of the intervention (for all outcomes and mediators). This project will be among the first to develop and test an HIV risk-reduction intervention designed specifically for African American MSMW.

The Primary Specifics Aims are to:

1. Determine the impact of the MAALES intervention on: (a) HIV-related sexual risk behaviors and (b) sex under the influence of drugs and alcohol among African American MSMW.

   1. Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing episodes of unprotected anal and vaginal intercourse and number of intercourse partners at the 3- and 6-month post assessments.
   2. Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing the number of episodes of drug and alcohol use prior to or during sex at the 3- and 6-month post assessments.
2. Determine the impact of the MAALES intervention condition on psychosocial outcomes, including reducing HIV stigma and increasing racial/cultural pride among African American MSMW.

Hypothesis: Compared to the control condition, the MAALES Intervention condition will be more effective in decreasing HIV stigma and improving racial/cultural pride at the immediate, 3- and 6-month post assessments.

Eligibility criteria: Inclusion Criteria:

* Self-identified man of African descent (black)
* 18 years of age or older
* English speaking
* Has had sex (oral, anal, mutual masturbation) with man or with a male-to-female transgender within the past 24 months.
* Has had sex (oral, anal, mutual masturbation) with a woman within the past 24 months.

Exclusion criteria:

* Participated in another HIV prevention study, in a small-group HIV prevention program or HIV prevention case management in the prior 6 months.

Primary outcomes:
measure: Reduced HIV-related risk sexual behaviors
timeFrame: 6 months
Secondary outcomes:
measure: Internalized Homophobia
timeFrame: 6 months
measure: Psychological distress
timeFrame: 6 months
measure: Psychosocial outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: JWCH Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: Charles Drew University
state: California
Study officials:
affiliation: Charles Drew University
name: Nina Hawara, MPH, Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: John K. Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AmASSI Health and Cultural Center
name: Cleo Manago
role: PRINCIPAL_INVESTIGATOR
affiliation: JWCH Institute, Inc.
name: Sergio Avina
role: PRINCIPAL_INVESTIGATOR
affiliation: Palms Residential Care Facility
name: Kevin Pickett
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams JK, Ramamurthi HC, Manago C, Harawa NT. Learning from successful interventions: A culturally congruent HIV risk-reduction intervention for African American men who have sex with men and women. Am J Public Health. 2009 Jun;99(6):1008-12. doi: 10.2105/AJPH.2008.140558. Epub 2009 Apr 16.
citation: Bingham TA, Harawa NT, Williams JK. Gender role conflict among African American men who have sex with men and women: associations with mental health and sexual risk and disclosure behaviors. Am J Public Health. 2013 Jan;103(1):127-33. doi: 10.2105/AJPH.2012.300855. Epub 2012 Nov 15.
citation: Harawa NT, Williams JK, McCuller WJ, Ramamurthi HC, Lee M, Shapiro MF, Norris KC, Cunningham WE. Efficacy of a culturally congruent HIV risk-reduction intervention for behaviorally bisexual black men: results of a randomized trial. AIDS. 2013 Jul 31;27(12):1979-88. doi: 10.1097/qad.0b013e3283617500.