Cleveland African American Prostate Cancer Project
1 other identifier
interventional
800
1 country
1
Brief Summary
The purpose of this research is to test intervention strategies that encourage and support Black or African American men who are 40 and older to complete prostate cancer screening, and specifically to complete a prostate-specific antigen (PSA) test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jun 2023
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 8, 2026
April 1, 2026
3.4 years
July 19, 2022
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
PSA Screening Test
The number of participants who had a PSA screening test completed.
At 4 months
Secondary Outcomes (3)
PSA Screening Test
At 14 months
Primary Care Physician Visit
At 4 months
Primary Care Physician Visit
At 14 months
Study Arms (3)
Education and Passive Navigation
EXPERIMENTALThis arm receives barber-led education and access to a resource website. Barbers will encourage clients to access the screening website. Other study materials will also be located within the shop. The resource website will be accessible via QR code that will encourage potential participants to complete a Prostate Cancer Knowledge and Risk Assessment questionnaire.
Education and Active Navigation
EXPERIMENTALThis arm includes all interventions of the first arm plus the addition of a community navigator. The community navigator will be onsite to assist in information delivery and navigation to resources and encourage the completion of the Screener through the QR code. The community navigator will help participants connect with a primary care provider to continue with all preventive healthcare recommendations.
Education and Active Navigation with Community Based Outreach
EXPERIMENTALThis arm adds the community navigator and a community outreach screening event. Case Comprehensive Cancer Center Community Outreach and Engagement will offer barber shops an onsite PSA screening event.
Interventions
Education: QR codes will be posted at each barber's station within a barber shop, as well as on other study materials located within the shop. The QR code recruitment mechanism will encourage potential participants to complete a Prostate Cancer Knowledge and Risk Assessment questionnaire (ie. Screener) which acts as a screener for study eligibility. The screener can be completed by scanning the QR code with a cell phone while in the barbershop. Barbers will encourage their clients to complete the Screener.
A community navigator will be onsite to assist in information delivery, navigation to resources, and encourage the completion of the Screener through the QR code. Participants can opt to connect with the community navigator if they have questions, need assistance in scheduling a PSA screening, or if they have other resource needs. The community navigator will help participants connect with a primary care provider to continue with all preventive healthcare recommendations.
The Community Navigator will set up PSA screening events at specific barber shops for participants who wish to move forward with screenings.
Eligibility Criteria
You may qualify if:
- ≥40 years old
- Self-identify as Black or African American
- Have a prostate gland (includes biological males, transwomen)
- PSA-naïve or has not received a PSA test in the past 12 months
- Has not had a previous prostate cancer diagnosis
- English speaking
- Ability to consent to study
You may not qualify if:
- Individuals who have had a prostatectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbershops Local to Cleveland
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Trapl, PhD
Case Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The data analyst will be blinded to the study arm assignments.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 21, 2022
Study Start
June 9, 2023
Primary Completion (Estimated)
October 28, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Available immediately after publication with no end date.
- Access Criteria
- Researchers who provide a sound proposal.
All IPD that underlies results in publication.