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Cleveland African American Prostate Cancer Project

Cleveland African American Prostate Cancer Project: Equivalence of Passive Navigation, Active Navigation, and Community-based Screening for Completion of Prostate Cancer Screening

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05469269
Enrollment
800
Registered
2022-07-21
Start date
2023-06-09
Completion date
2027-09-30
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Detailed description

This intervention is designed to evaluate the effectiveness of three different approaches to increasing PSA screening in African American men, starting at age 40. The approaches are 1) education and passive navigation, 2) education and active navigation, and 3) education and active navigation with community based outreach. Completion of a PSA blood test is the primary outcome of this study, which will be evaluated four months following the recruitment phase at each shop. At the 4 month follow-up, participants will be asked about PSA completion; participants who completed PSA screening will be asked to provide outcomes from their PSA screening (ie. PSA results and provider recommended next steps), as well as their feelings regarding their screening experience, trust in the screening process, and knowledge about prostate cancer.

Interventions

BEHAVIORALPassive Education

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.

BEHAVIORALEducation by Community Navigator

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.

BEHAVIORALEducation at Community Outreach Screening Event

The Community Navigator will set up PSA screening events at specific barber shops for participants who wish to move forward with screenings.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Masking description

The data analyst will be blinded to the study arm assignments.

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ≥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

Exclusion criteria

* Individuals who have had a prostatectomy

Design outcomes

Primary

MeasureTime frameDescription
PSA Screening TestAt 4 monthsThe number of participants who had a PSA screening test completed.

Secondary

MeasureTime frameDescription
PSA Screening TestAt 14 monthsThe number of participants who had a PSA screening test completed.
Primary Care Physician VisitAt 4 monthsThe number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.

Countries

United States

Contacts

CONTACTErika Trapl, PhD
CAAPP@case.edu216-368-8772
PRINCIPAL_INVESTIGATORErika Trapl, PhD

Case Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026