NCT01980771

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 14, 2018

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

October 29, 2013

Results QC Date

August 16, 2018

Last Update Submit

October 25, 2021

Conditions

Keywords

HIVpreventionmenAfrican American

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six month follow-up

Study Arms (2)

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.

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.

Behavioral: Cancer prevention and screening

Interventions

Men work in groups to complete a intervention that takes approximately two hours to complete.

BTWB intervention

Men are provided health education about cancer screening and prevention

Cancer prevention and screening

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unprotected sex in the past three months
  • Identify as Black or African American

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arthur Ashe Institute for Urban Health, Inc.

Brooklyn, New York, 11203, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Results Point of Contact

Title
Tracey Wilson, Principal Investigator
Organization
State University of New York, Downstate Medical Center

Study Officials

  • Tracey E Wilson, PhD

    State University of New York - Downstate Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 11, 2013

Study Start

November 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 27, 2021

Results First Posted

November 14, 2018

Record last verified: 2021-10

Locations