HIVNCT01980771
Barbershop Talk: HIV Prevention for African American Heterosexual Men
A study testing BTWB intervention and Cancer prevention and screening in people with HIV, run by State University of New York - Downstate Medical Center at 2 sites in United States.
Trial summary
This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. 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?
- BTWB intervention and Cancer prevention and screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Unprotected sex in the past three months
- Identify as Black or African American
Who cannot join
- Having been in an HIV prevention research study in the last six months
- Reporting a history in the past five years of injection drug use
- Reporting a history in the past five years of having sex with other men
- Reporting an HIV-positive serostatus
- Inability to understand spoken English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arthur Ashe Institute for Urban Health, Inc.
Brooklyn, New York, 11203
SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.
- Conditions
- HIV
- Being tested
- BTWB intervention, Cancer prevention and screening
- Keywords
- HIV, prevention, men, African American
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTWB interventionBehavioural
Men work in groups to complete a intervention that takes approximately two hours to complete.
Cancer prevention and screeningBehavioural
Men are provided health education about cancer screening and prevention
| Study group | Role | What they receive |
|---|---|---|
| BTWB intervention | Experimental | Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. Receives: Behavioral: BTWB intervention |
| Cancer prevention and screening | Active comparator | Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. Receives: Behavioral: Cancer prevention and screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Behavior
Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.
Measured: Six month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Tracey Wilson, State University of New York - Downstate Medical Center
- Investigators
- Tracey E Wilson, PhD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980771
- Sponsor's protocol ID
- 5P20MD006875, subproject 5174
- Other IDs
- 5P20MD006875
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2013
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wilson TE, Gousse Y, Joseph MA, Browne RC, Camilien B, McFarlane D, Mitchell S, Brown H, Urraca N, Romeo D, Johnson S, Salifu M, Stewart M, Vavagiakis P, Fraser M. HIV Prevention for Black Heterosexual Men: The Barbershop Talk with Brothers Cluster Randomized Trial. Am J Public Health. 2019 Aug;109(8):1131-1137. doi: 10.2105/AJPH.2019.305121. Epub 2019 Jun 20.
PubMed 31219715
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbershop Talk: HIV Prevention for African American Heterosexual Men
- ClinicalTrials.gov ID
- NCT01980771
- Acronym / sponsor ID
- 5P20MD006875, subproject 5174
- Conditions
- HIV
- Keywords
- HIV, prevention, men, African American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTWB intervention | Experimental | Behavioral: BTWB interventionBarbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. |
| Cancer prevention and screening | Active comparator | Behavioral: Cancer prevention and screeningBarbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unprotected sex in the past three months
- Identify as Black or African American
Key exclusion criteria (5 listed)
- Having been in an HIV prevention research study in the last six months
- Reporting a history in the past five years of injection drug use
- Reporting a history in the past five years of having sex with other men
- Reporting an HIV-positive serostatus
- Inability to understand spoken English.
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 |
|---|---|---|
| BTWB interventionMen work in groups to complete a intervention that takes approximately two hours to complete. | Behavioural | BTWB intervention |
| Cancer prevention and screeningMen are provided health education about cancer screening and prevention | Behavioural | Cancer prevention and screening |
Primary outcome
Sexual Behavior
Time frame: Six month follow-up
Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31219715Wilson TE, Gousse Y, Joseph MA, Browne RC, Camilien B, McFarlane D, Mitchell S, Brown H, Urraca N, Romeo D, Johnson S, Salifu M, Stewart M, Vavagiakis P, Fraser M. HIV Prevention for Black Heterosexual Men: The Barbershop Talk with Brothers Cluster Randomized Trial. Am J Public Health. 2019 Aug;109(8):1131-1137. doi: 10.2105/AJPH.2019.305121. Epub 2019 Jun 20.
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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.
Tracey E Wilson, PhD principal investigator
State University of New York - Downstate Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTWB intervention and Cancer prevention and screening in people with HIV, run by State University of New York - Downstate Medical Center 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 2 inclusion and 5 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 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Behavior (time frame: Six month follow-up). 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 NCT01980771, which also lists 1 linked publication.
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 2021.