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NCT Number: NCT05469269

Cleveland African American Prostate Cancer Project

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Barbershops Local to Cleveland

Cleveland, Ohio, 44106, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive Education

Behavioral

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.

Education by Community Navigator

Behavioral

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.

Education at Community Outreach Screening Event

Behavioral

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

Primary outcomes

  1. PSA Screening Test

    Time frame: At 4 months

    The number of participants who had a PSA screening test completed.

Secondary outcomes

  1. PSA Screening Test

    Time frame: At 14 months

    The number of participants who had a PSA screening test completed.

  2. Primary Care Physician Visit

    Time frame: At 4 months

    The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.

  3. Primary Care Physician Visit

    Time frame: At 14 months

    The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Trapl, PhD

CONTACT

[email protected]

216-368-8772

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 21, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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