Men of African American Legacy Empowering Self

HIV Clinical Trial

— MAALES  

Official title:

Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492530
• Other study ID #: AL04-DREW-840
• Secondary ID: 2P20MD000182
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2011
• Last updated: June 10, 2014
• Start date: August 2007
• Est. completion date: March 2012

Study information

• Verified date: June 2014
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Men of African American Legacy Empowering Self
Small group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks.
• Standard HIV Education & Risk Reduction
Single, individual counseling and education session. Lasting 20-30 minutes.

Locations

Country	Name	City	State
United States	Charles Drew University	Los Angeles	California
United States	JWCH Institute, Inc.	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	California HIV/AIDS Research Program, National Institute on Minority Health and Health Disparities (NIMHD), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced HIV-related risk sexual behaviors	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.	6 months	No
Secondary	Internalized Homophobia	Examine whether reductions in internalized homophobia and gender role conflicts act as mediators of the effect of the MAALES Intervention condition on HIV risk behaviors (i.e., unprotected sexual intercourse and sex under the influence of drugs).	6 months	No
Secondary	Psychological distress	Examine whether psychological distress (i.e., depression and anxiety) predicts for risky sexual behaviors and moderates the MAALES intervention condition's efficacy.	6 months	No
Secondary	Psychosocial outcomes	Determine the impact of the MAALES Intervention condition on psychosocial outcomes including reducing stigma and increasing racial/cultural pride among African American MSMW.	6 months	No