- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980771
Barbershop Talk: HIV Prevention for African American Heterosexual Men
October 25, 2021 updated by: Tracey Wilson, State University of New York - Downstate Medical Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
860
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11203
- SUNY Downstate Medical Center
-
Brooklyn, New York, United States, 11203
- Arthur Ashe Institute for Urban Health, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Unprotected sex in the past three months
- Identify as Black or African American
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BTWB intervention
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.
|
Men work in groups to complete a intervention that takes approximately two hours to complete.
|
|
Active Comparator: Cancer prevention and screening
Barbershops are assigned to either experimental or control condition.
Men recruited from control barbershops receive information on cancer prevention and control.
|
Men are provided health education about cancer screening and prevention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Six month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tracey E Wilson, PhD, State University of New York - Downstate Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
October 29, 2013
First Submitted That Met QC Criteria
November 4, 2013
First Posted (Estimate)
November 11, 2013
Study Record Updates
Last Update Posted (Actual)
October 27, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5P20MD006875, subproject 5174
- 5P20MD006875 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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