A pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol

Background: Prostate cancer is the most diagnosed cancer in Black/African American men (AA) and the second-leading cause of cancer-related deaths. A prostate-specific antigen (PSA) blood testis an early detection screening tool for prostate cancer, but uptake of PSA screening remains low among AA men. Greater PSA screening rates among AA men, coupled with earlier treatment, may reduce disparities in prostate cancer outcomes, including mortality. The current pilot study will test the first-of-its-kind mobile health (mHealth) app to improve prostate cancer knowledge and increase PSA screening uptake among AA men using home-based screening methods. Methods: AA men aged 55 to 69 and are not up to date with PSA screening will be randomly assigned 1:1 to receive a prostate cancer screening app: Prevention Taskforce App (Taskforce App; control condition) or the Prostate Cancer Genius App (Genius App; intervention condition), which was developed specifically for AA men. Results: We will evaluate the preliminary efficacy of the apps via post-intervention group differences on the validated 18-item Prostate Cancer Knowledge Scale (primary outcome). We will also explore post-intervention group differences in perceived engagement, accessibility, and acceptability between the apps. Finally, we will derive preliminary estimates of PSA screening rates between study conditions and identify mechanisms of screening adherence. Discussion: mHealth apps offer promise to improve prostate cancer knowledge and screening rates among AA men. Demonstrating the preliminary efficacy of the Genius App will support future fully-powered mHealth interventions to address health disparities.