HIV InfectionPhase 2NCT01270230
A Randomized Controlled Trial of the Bruthas Project
A Phase 2 study testing Bruthas Project and Standard HIV Testing and Counseling in people with HIV Infection, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Bruthas Project and Standard HIV Testing and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2016
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older
- African American
- Male
- History of sex with male and female partners in the past two years
- English speaker
Who cannot join
- participation in previous research with Bruthas Project
- non English speaker
- identifies as gay
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94105
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infection
- Being tested
- Bruthas Project, Standard HIV Testing and Counseling
- Keywords
- HIV Prevention Intervention, African American Men who have Sex with Men
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruthas ProjectBehavioural
The Bruthas Project HIV prevention intervention is a four-session, semi-structured individual risk reduction counseling program based on the Information-Motivation-Behavior (IMB) theoretical model. The counseling sessions are designed to complement standardized HIV-Counseling and Testing, and are delivered every 2-3 weeks over the course of 3 months. Each session lasts for approximately one hour, and is facilitated by a trained African American male counselor. The counselors engage with participants using open-ended questions and a non-judgmental, conversational style designed to elicit feedback on an individual's current level of HIV-related risk. The counselor then provides information and strengthens the participant's prevention skills.
Standard HIV Testing and CounselingBehavioural
This arm represents those receiving the standard HIV testing and counseling. We ultimately settled on the standard-of-care comparison group because our primary research question is whether the implementation of the intervention cast against the backdrop of usual care, in this case, HIV testing and counseling as mandated by the CDC, is efficacious. Thus, participants randomized to the comparison group will receive the current standard intervention which involves HIV testing, pre- and post-test counseling, plus linkage to case management. Individuals who test HIV-positive will be referred to post-test services including counseling for treatment options, HIV-positive support groups, and harm reduction workshops.
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group, Standard HIV-CT | Experimental | The comparison group will receive standardized HIV counseling and testing (HIV-CT), with referrals to case management. Receives: Behavioral: Standard HIV Testing and Counseling |
| Intervention Group, Bruthas Counseling | Experimental | Participants assigned to this arm receive four individual HIV prevention counseling sessions. Receives: Behavioral: Bruthas Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual risk behavior with male and female partners
Our primary outcome measure will feature two approaches to assessing HIV risk: we will assess (a) general sexual risk behaviors during the past 3 months and (b) event-level characteristics of sexual risk episodes for the past 1 month. Participants will report on general sexual activity during the past 3 months, including insertive vaginal sex, insertive/receptive anal sex, and giving/receiving oral sex. They will report on overall number of episodes, number of unprotected episodes, and episodes by partner type (main, casual, paying) and by partner gender (male, female).
Measured: 9-months
Secondary outcomes (1)
HIV Testing
We will ask participants the date of their most recent HIV test.
Measured: 9 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Emily A Arnold, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270230
- Sponsor's protocol ID
- 1R01MH09089901-A1
- Other IDs
- R01MH090899
- Status last verified
- Oct 2016
- First submitted
- 2 Dec 2010
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Bruthas Project
- ClinicalTrials.gov ID
- NCT01270230
- Acronym / sponsor ID
- 1R01MH09089901-A1
- Conditions
- HIV Infection
- Keywords
- HIV Prevention Intervention, African American Men who have Sex with Men
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Jan 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group, Standard HIV-CT | Experimental | Behavioral: Standard HIV Testing and CounselingThe comparison group will receive standardized HIV counseling and testing (HIV-CT), with referrals to case management. |
| Intervention Group, Bruthas Counseling | Experimental | Behavioral: Bruthas ProjectParticipants assigned to this arm receive four individual HIV prevention counseling sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 or older
- African American
- Male
- History of sex with male and female partners in the past two years
- English speaker
Key exclusion criteria (3 listed)
- participation in previous research with Bruthas Project
- non English speaker
- identifies as gay
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 |
|---|---|---|
| Bruthas ProjectThe Bruthas Project HIV prevention intervention is a four-session, semi-structured individual risk reduction counseling program based on the Information-Motivation-Behavior (IMB) theoretical model. The counseling sessions are designed to complement standardized HIV-Counseling and Testing, and are delivered every 2-3 weeks over the course of 3 months. Each session lasts for approximately one hour, and is facilitated by a trained African American male counselor. The counselors engage with participants using open-ended questions and a non-judgmental, conversational style designed to elicit feedback on an individual's current level of HIV-related risk. The counselor then provides information and strengthens the participant's prevention skills. | Behavioural | Intervention Group, Bruthas Counseling |
| Standard HIV Testing and CounselingThis arm represents those receiving the standard HIV testing and counseling. We ultimately settled on the standard-of-care comparison group because our primary research question is whether the implementation of the intervention cast against the backdrop of usual care, in this case, HIV testing and counseling as mandated by the CDC, is efficacious. Thus, participants randomized to the comparison group will receive the current standard intervention which involves HIV testing, pre- and post-test counseling, plus linkage to case management. Individuals who test HIV-positive will be referred to post-test services including counseling for treatment options, HIV-positive support groups, and harm reduction workshops. | Behavioural | Comparison Group, Standard HIV-CT |
Primary outcome
sexual risk behavior with male and female partners
Time frame: 9-months
Our primary outcome measure will feature two approaches to assessing HIV risk: we will assess (a) general sexual risk behaviors during the past 3 months and (b) event-level characteristics of sexual risk episodes for the past 1 month. Participants will report on general sexual activity during the past 3 months, including insertive vaginal sex, insertive/receptive anal sex, and giving/receiving oral sex. They will report on overall number of episodes, number of unprotected episodes, and episodes by partner type (main, casual, paying) and by partner gender (male, female).
1 secondary outcome
HIV Testing
Time frame: 9 months follow up
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 27 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Emily A Arnold, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bruthas Project and Standard HIV Testing and Counseling in people with HIV Infection, run by University of California, San Francisco at 1 site 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 3 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
sexual risk behavior with male and female partners (time frame: 9-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016.