A Randomized Controlled Trial of the Bruthas Project
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | February 2011 |
End Date: | August 2016 |
African American men who have sex with men and women (AAMSMW) are at particular risk for
contracting and transmitting HIV, and represent a priority population for developing
effective interventions. Despite the urgent need for effective prevention approaches for
AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested
for this population. This study is a randomized controlled trial of the Bruthas Project(BP),
an individual-level HIV prevention intervention, which builds on standardized HIV counseling
and testing. Delivered in a series of four sessions by trained African American male
counselors, the BP focuses on reviewing HIV transmission routes for male and female
partners, strengthening sexual communication skills with both male and female partners, and
improving condom use skills and other safer sex negotiation strategies. A randomized
controlled trial of BP is necessary to determine the efficacy of the intervention and can
lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the
African American community more generally. To evaluate the effect of the BP, the
investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned
to either the intervention condition, in which they will be offered BP, or to the comparison
condition, in which they will receive standardized HIV testing and counseling with referral
to case management. The investigators will follow the cohort over 9 months and will assess
participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.
contracting and transmitting HIV, and represent a priority population for developing
effective interventions. Despite the urgent need for effective prevention approaches for
AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested
for this population. This study is a randomized controlled trial of the Bruthas Project(BP),
an individual-level HIV prevention intervention, which builds on standardized HIV counseling
and testing. Delivered in a series of four sessions by trained African American male
counselors, the BP focuses on reviewing HIV transmission routes for male and female
partners, strengthening sexual communication skills with both male and female partners, and
improving condom use skills and other safer sex negotiation strategies. A randomized
controlled trial of BP is necessary to determine the efficacy of the intervention and can
lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the
African American community more generally. To evaluate the effect of the BP, the
investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned
to either the intervention condition, in which they will be offered BP, or to the comparison
condition, in which they will receive standardized HIV testing and counseling with referral
to case management. The investigators will follow the cohort over 9 months and will assess
participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.
African Americans account for half of all Americans currently living with AIDS, and men
account for two-thirds of all African Americans with HIV. AAMSMW are at particular risk for
contracting and transmitting HIV, and represent a priority population for developing
effective interventions. Studies of AAMSMW conducted in multiple HIV-epicenters in the
United States have reported high rates of unprotected intercourse with male and female
partners, concurrent partnerships, and frequent substance use before sex, accompanied by
non-disclosure and secrecy regarding sexual risk behaviors. These behavioral dynamics are
likely to fuel transmission of HIV and other STDs in diverse sexual networks and
communities. Despite the urgent need for effective prevention approaches for AAMSMW, to our
knowledge no evidence-based HIV interventions have been developed and tested for this
population.
We propose to test a behavioral prevention intervention, the BP, to reduce HIV-related
sexual risk behavior among AAMSMW. The intervention was designed through four years of
formative research with AAMSMW consisting of: (1) qualitative in-depth interviews, focus
groups and field ethnography; (2) protocol and measure development; (3) pilot testing and
evaluation; and (4) further refinement following process and preliminary outcome data. The
BP counseling process was formulated on principles of the Information-Motivation-Behavior
(IMB) theory of HIV prevention, and is characterized by an individual-level counseling
process that is specifically tailored to recognize the social and cultural contexts that
inform sexual behavior for AAMSMW. Delivered in a series of four sessions by trained African
American male counselors, the BP focuses on reviewing HIV transmission routes for male and
female partners, strengthening sexual communication skills with both male and female
partners, and improving condom use skills and other safer sex negotiation strategies.
Evidence thus far indicates that BP is an acceptable and feasible model for providing HIV
prevention counseling to this population, and pilot outcome data show promising indications
of behavior change. A team of trained BP staff have successfully utilized a multi-tiered
outreach approach to identify AAMSMW, recruit eligible individuals, and engage and retain
participants in a longitudinal evaluation design. A randomized controlled trial of BP is
necessary to determine the efficacy of the intervention and can lead to improved public
health efforts at reducing HIV risk behavior among AAMSMW and in the African American
community more generally.
account for two-thirds of all African Americans with HIV. AAMSMW are at particular risk for
contracting and transmitting HIV, and represent a priority population for developing
effective interventions. Studies of AAMSMW conducted in multiple HIV-epicenters in the
United States have reported high rates of unprotected intercourse with male and female
partners, concurrent partnerships, and frequent substance use before sex, accompanied by
non-disclosure and secrecy regarding sexual risk behaviors. These behavioral dynamics are
likely to fuel transmission of HIV and other STDs in diverse sexual networks and
communities. Despite the urgent need for effective prevention approaches for AAMSMW, to our
knowledge no evidence-based HIV interventions have been developed and tested for this
population.
We propose to test a behavioral prevention intervention, the BP, to reduce HIV-related
sexual risk behavior among AAMSMW. The intervention was designed through four years of
formative research with AAMSMW consisting of: (1) qualitative in-depth interviews, focus
groups and field ethnography; (2) protocol and measure development; (3) pilot testing and
evaluation; and (4) further refinement following process and preliminary outcome data. The
BP counseling process was formulated on principles of the Information-Motivation-Behavior
(IMB) theory of HIV prevention, and is characterized by an individual-level counseling
process that is specifically tailored to recognize the social and cultural contexts that
inform sexual behavior for AAMSMW. Delivered in a series of four sessions by trained African
American male counselors, the BP focuses on reviewing HIV transmission routes for male and
female partners, strengthening sexual communication skills with both male and female
partners, and improving condom use skills and other safer sex negotiation strategies.
Evidence thus far indicates that BP is an acceptable and feasible model for providing HIV
prevention counseling to this population, and pilot outcome data show promising indications
of behavior change. A team of trained BP staff have successfully utilized a multi-tiered
outreach approach to identify AAMSMW, recruit eligible individuals, and engage and retain
participants in a longitudinal evaluation design. A randomized controlled trial of BP is
necessary to determine the efficacy of the intervention and can lead to improved public
health efforts at reducing HIV risk behavior among AAMSMW and in the African American
community more generally.
Inclusion Criteria:
- 18 or older
- African American
- Male
- History of sex with male and female partners in the past two years
- English speaker
Exclusion Criteria:
- participation in previous research with Bruthas Project
- non English speaker
- identifies as gay
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