Connect2Care: Prostate Cancer Education and Screenings for African American Men

NCT07055165 | Recruiting

• 1 other identifier: 18003
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening tool for prostate cancer, however, knowledge about prostate cancer and screening benefits and risks and uptake of PSA screening remains low among African American men. To address this inequity, this project proposes the use of the Connect2Care App to improve knowledge of prostate cancer, screening benefits, risks and increase readiness to complete a PSA test (e.g., intentions, motivation, confidence, and self-efficacy). The primary goal of this study is to evaluate the efficacy of the Connect2Care App in a 30-day randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men between the ages of 45 and 69 from Oklahoma (N = 266), who are not up to date with PSA screening according to recommended guidelines, will be randomly assigned 1:1 to receive either app. The app feasibility will be assessed: (1) efficacy, evaluated via post-intervention differences in knowledge of prostate cancer, screening benefits and risks, (2) app engagement and accessibility, measured via self-report validated questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. We will explore readiness to complete a PSA test and identify predictors of readiness across both study arms. The successful demonstration of the feasibility of the Connect2Care App among African American men living in Oklahoma will support expanding this intervention to African American men nationwide.

Conditions

Prostate Cancer; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Awareness

  Awareness will be measured by reach and penetration of the intervention. For the Social Media Campaign, reach will be determined by the percentage of participants who successfully engage with intervention and will be calculated by the number of impressions (i.e., number of times adverts are seen) divided by the number of times participants engaged with the intervention (i.e., click through rate). This will determine a click through rate, which can be calculated per study ad and geographic region. For the Community Health Events, reach will be determined by the number of events hosted and the number of participants who attend. Penetration will also be explored through a geographic informational systems (GIS) analysis to better understand whether spatial (e.g., distance to CHCO sites) and/or participant-level characteristics (e.g., age) were associated with greater likelihood to engage with the intervention (both Social Media Campaign and Community Health Events) and/or complete a PSA.

  30 Days

Secondary Outcomes (1)

• Access

  30 Days

Study Arms (2)

Genius app

EXPERIMENTAL

The Prostate Cancer Genius app includes the following components: (1) educational content that is consistent with existing evidence and recommendations for prostate cancer and prostate cancer screening but has been adapted for the African American male population and for adults who read at or below the 8th-grade level; (2) real-time messages about the risks of prostate cancer and the benefits of completing a PSA test, placing a special emphasis on screening considerations for individuals with a family history of prostate cancer and/or lower urinary tract symptoms (measured via the American Urological Association Symptom Score); (3) general trivia that also incorporates quiz questions about prostate cancer and the PSA test; (4) African American-specific testimonials and educational videos; (5) optional counseling by African American prostate cancer survivors; and (6) on-demand, automated ordering of a home-based PSA test.

Behavioral: Prostate Cancer Genius App

Prevention Taskforce app

ACTIVE COMPARATOR

The Prevention Taskforce app provides on-demand access to evidence-based recommendations for prostate cancer for men between 55 and 69 (i.e., it can be accessed as needed).

Behavioral: US Prevention Taskforce App

Interventions

Prostate Cancer Genius App BEHAVIORAL

Participants assigned to use the Prostate Cancer Genius App will receive a combination of (a) scheduled and (b) on-demand content prostate cancer for one month. Scheduled content will be delivered on specific days each week using app notifications. Participants will also receive tailored navigation for ordering a home-based PSA kit, including receiving follow-up information from trained medical professionals about their test results.

Genius app

US Prevention Taskforce App BEHAVIORAL

Participants assigned to use the US Prevention Task Force app will download the app from Google Play and will be instructed to use the app for one-month to to become more informed about prostate cancer. They will also be instructed to download a companion app from the Google Play store. This companion app will be used to deliver weekly assessments and order a home-based PSA test kit if the participant chooses to so. Participants assigned to the Prevention Taskforce app will receive a brochure providing details about the purpose of the home-based PSA test.

Prevention Taskforce app

Eligibility Criteria

• Age: 45 Years - 69 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in Oklahoma
• Self-identify as Black/African American
• Self-identify as male
• Between ages 45-69
• Not currently diagnosed with prostate cancer

You may not qualify if:

• Participants will be excluded if they are not interested in using a phone app for 30 days
• Has taken a PSA test or has completed PSA screening within the past two years

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Health Behavior

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Jordan Neil, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Neil, PhD

CONTACT

(405) 271-5046; jordan-neil@ouhsc.edu

Adam Alexander, PhD

CONTACT

(405) 271-5046; adam-alexander@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 8, 2025
• Study Start: July 26, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)