NCT07055165 · University of Oklahoma
Connect2Care: Prostate Cancer Education and Screenings for African American Men
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Prostate Cancer Genius App
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.
BEHAVIORAL
US Prevention Taskforce App
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.
Primary outcome measures
Awareness
Time frame: 30 Days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Live in Oklahoma
- Self-identify as Black/African American
- Self-identify as male
- Between ages 45-69
- Not currently diagnosed with prostate cancer
Exclusion criteria
- 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
Where
- Oklahoma City, Oklahoma
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations