HIVPhase 2MAALESNCT01492530
Men of African American Legacy Empowering Self
A Phase 2 study testing Men of African American Legacy Empowering Self and Standard HIV Education & Risk Reduction in people with HIV, run by Charles Drew University of Medicine and Science at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Men of African American Legacy Empowering Self and Standard HIV Education & Risk Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participated in another HIV prevention study, in a small-group HIV prevention program or HIV prevention case management in the prior 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
JWCH Institute, Inc.
Los Angeles, California, 90013
Charles Drew University
Los Angeles, California, 90059
About this study
Official title: Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men
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.
Read the 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:
- 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.
- 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.
- 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.
- 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
- HIV
- Being tested
- Men of African American Legacy Empowering Self, Standard HIV Education & Risk Reduction
- Keywords
- Men who have sex with Men and Women, HIV Prevention, Behavioral Intervention, Condom use, African American MSMW
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Men of African American Legacy Empowering SelfBehavioural
Also called MAALES
Small group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks.
Standard HIV Education & Risk ReductionBehavioural
Also called Standard HERR Counseling Session
Single, individual counseling and education session. Lasting 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 6-session, small group | Experimental | 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. Receives: Behavioral: Men of African American Legacy Empowering Self |
| HIV Education & Risk Reduction Session | Active comparator | 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. Receives: Behavioral: Standard HIV Education & Risk Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 6 months
Psychological distress
Examine whether psychological distress (i.e., depression and anxiety) predicts for risky sexual behaviors and moderates the MAALES intervention condition's efficacy.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startAug 2007
- Primary completionMay 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), California HIV/AIDS Research Program, University of California, Los Angeles
- Responsible party
- Principal investigator, Nina Harawa, Charles Drew University of Medicine and Science
- Investigators
- Nina Hawara, MPH, Ph. D, Principal investigator, Charles Drew UniversityJohn K. Williams, MD, Principal investigator, University of California, Los AngelesCleo Manago, Principal investigator, AmASSI Health and Cultural CenterSergio Avina, Principal investigator, JWCH Institute, Inc.Kevin Pickett, Principal investigator, Palms Residential Care Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492530
- Sponsor's protocol ID
- AL04-DREW-840
- Other IDs
- 2P20MD000182
- Acronym
- MAALES
- Status last verified
- Jun 2014
- First submitted
- 9 Dec 2011
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19372517Bingham 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.
PubMed 23153143Harawa 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.
PubMed 24180003
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Risk Behaviors and Psychosocial Stressors Among Bisexual African American Men
- ClinicalTrials.gov ID
- NCT01492530
- Acronym / sponsor ID
- MAALES / AL04-DREW-840
- Conditions
- HIV
- Keywords
- Men who have sex with Men and Women, HIV Prevention, Behavioral Intervention, Condom use, African American MSMW
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), California HIV/AIDS Research Program, University of California, Los Angeles
- Study start
- Aug 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-session, small group | Experimental | Behavioral: Men of African American Legacy Empowering SelfMen 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. |
| HIV Education & Risk Reduction Session | Active comparator | Behavioral: Standard HIV Education & Risk Reduction20-30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Participated in another HIV prevention study, in a small-group HIV prevention program or HIV prevention case management in the prior 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Men of African American Legacy Empowering SelfAlso: MAALESSmall group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks. | Behavioural | 6-session, small group |
| Standard HIV Education & Risk ReductionAlso: Standard HERR Counseling SessionSingle, individual counseling and education session. Lasting 20-30 minutes. | Behavioural | HIV Education & Risk Reduction Session |
Primary outcome
Reduced HIV-related risk sexual behaviors
Time frame: 6 months
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.
3 secondary outcomes
Internalized Homophobia
Time frame: 6 months
Psychological distress
Time frame: 6 months
Psychosocial outcomes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Background: PubMed 19372517Williams 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.
- Background: PubMed 23153143Bingham 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.
- Results publication: PubMed 24180003Harawa 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.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Hawara, MPH, Ph. D principal investigator
Charles Drew University
John K. Williams, MD principal investigator
University of California, Los Angeles
Cleo Manago principal investigator
AmASSI Health and Cultural Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Men of African American Legacy Empowering Self and Standard HIV Education & Risk Reduction in people with HIV, run by Charles Drew University of Medicine and Science at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced HIV-related risk sexual behaviors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492530, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.