Study Results
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Basic Information
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COMPLETED
PHASE2
437 participants
INTERVENTIONAL
2007-08-31
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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6-session, small group
Men of African American Legacy Empowering Self (MAALES) Intervention, a six-session, theoretically grounded, small-group intervention held over 3 weeks. Includes an additional 2 booster sessions at 6 and 18 weeks following Session 6.
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.
HIV Education & Risk Reduction Session
20-30 minute standard, client-centered HIV education and risk-reduction session administered over the phone or in person. Similar to that received during pre-test counseling for HIV testing.
Standard HIV Education & Risk Reduction
Single, individual counseling and education session. Lasting 20-30 minutes.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
California HIV/AIDS Research Program
OTHER
University of California, Los Angeles
OTHER
Charles Drew University of Medicine and Science
OTHER
Responsible Party
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Nina Harawa
Associate Professor
Principal Investigators
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Nina Hawara, MPH, Ph. D
Role: PRINCIPAL_INVESTIGATOR
Charles Drew University
John K. Williams, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Cleo Manago
Role: PRINCIPAL_INVESTIGATOR
AmASSI Health and Cultural Center
Sergio Avina
Role: PRINCIPAL_INVESTIGATOR
JWCH Institute, Inc.
Kevin Pickett
Role: PRINCIPAL_INVESTIGATOR
Palms Residential Care Facility
Locations
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JWCH Institute, Inc.
Los Angeles, California, United States
Charles Drew University
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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AL04-DREW-840
Identifier Type: -
Identifier Source: org_study_id
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