A Randomized Controlled Trial On Improving Prostate Cancer Screening Among Black Men in Oklahoma Using A Community-Based mHealth Approach (Prostate Cancer Genius App) - PROJECT ABSTRACT. Prostate cancer (PCa) is the most commonly diagnosed cancer among Black men in Oklahoma and the U.S., with mortality rates 2 to 4 times higher than other racial groups. Despite evidence that prostate-specific antigen (PSA) screening reduces mortality and healthcare costs, screening rates remain low, particularly in Oklahoma (27% screened in the past two years). Barriers such as limited provider engagement, knowledge gaps, and healthcare access challenges contribute to lower screening rates, underscoring the need for innovative, scalable interventions to improve early detection. To address this, we developed the Prostate Cancer Genius App (PCGA), a smartphone-based intervention that provides PCa education and navigation for a user-friendly, CLIA-certified at-home PSA test. In a pilot RCT of 94 Black men aged 55–69, PCGA users demonstrated significantly greater PCa knowledge (p<0.05) and higher app usability (p<0.05) compared to the Prevention Taskforce App (PTFA), a general screening tool developed by the U.S. Preventive Services Task Force. PCGA users also showed higher PSA test activation (51.2% vs. 43.9%) and completion (83.3% vs. 50%), suggesting improved engagement and clearer navigation. This fully powered RCT will evaluate PCGA’s efficacy compared to PTFA and usual care (UC) among 684 Black men aged 55–69 in Oklahoma who are not up to date with PSA screening. Participants will be randomized 1:1:1 into PCGA (n=228), PTFA (n=228), or UC (n=228) and engage with their assigned intervention for 30 days, with follow-up for 6 months. The study will evaluate PSA screening completion (primary outcome) and screening readiness (i.e., knowledge, intentions, motivation, self-efficacy), diagnostic follow-up, treatment initiation, and satisfaction with care. Additionally, we will assess social needs as a moderator of screening and follow-up outcomes. Aligned with NOT-CA-24-033, this study will provide valuable insights into scalable, home-based PSA screening interventions that integrate telehealth-based shared decision-making. Findings will inform strategies to improve screening rates and follow-up care using tailored digital health tools. This research will also explore the role of clinic-based vs. home-based screening pathways to determine the most effective model for increasing PSA screening uptake. By rigorously assessing intervention engagement, screening readiness, and follow-up outcomes, this study aims to provide critical evidence for a sustainable and accessible approach to PCa early detection.
