Feasibility of Establishing Community Living Labs (CoLLabs) to Improve Access to Prostate Health Resources, Education, Amenities, and Community Health: Protocol for a Pragmatic Clinical Trial.

Abstract

In 2022, nearly 60,000 prostate cancer (CaP) cases were reported among Black men, who face an estimated lifetime risk of approximately 1 in 6, compared with 1 in 8 among White men. The disproportionate burden of CaP in Black men has been attributed to a combination of health-system factors, variations in care processes, and individual- or patient-level determinants. Addressing these multilevel contributors will require innovative strategies to advance prostate health equity. In this paper, we discuss the protocol for assessing the feasibility of establishing a Community Living Lab (CoLLab) Learning Health System in Black communities and the impact on facilitating access to prostate health Resources, Education, Amenities, and Community Health (REACH) services for Black men. The proposed research design for the study is a pragmatic clinical trial. The research setting is Northeast Florida, with the intervention based in 3 American Legion Posts (ALPs) and the control in one ALP. The development of the CoLLab REACH intervention was guided by the Intervention Mapping Framework, focusing on program design, adoption, implementation, and monitoring and evaluation plan. The intervention was cocreated with community members and is being provided by community health workers. The primary outcomes are improvement of Black men's CaP awareness, knowledge, attitude, health beliefs, perceived control, intentions, cues to action, and clinical trials' awareness. Generalized linear mixed regression approaches will be used to determine the differences between the study variables for the intervention and control groups. The CoLLab study was awarded in September 2023 and received institutional ethics committee approval on March 20, 2024. CoLLab REACH intervention includes the following services: (1) Wellness RX program, implemented to address financial health needs and grocery distribution to address food deserts of the communities around the posts; (2) social determinants of health Navigation Services that include food, housing, transportation, employment aid, legal aid, and financial support based on zip code; (3) educational resources and videos on CaP prevention, screening, detection, treatment, and survivorship; (4) The Clinical Trials Matching Services to match participants to Mayo Clinic clinical trials and biomedical research; and (5) CaP Advocacy training program. Baseline recruitment for the intervention arm was completed in June 2025, with 183 Black men enrolled at ALPs. By June 2025, 11 participants were enrolled at the control ALP, and recruitment for the control arm remains ongoing. Data analysis will be conducted upon completion of follow-up assessments at months 4, 8, and 12. We successfully co-designed the CoLLab REACH services at 3 ALPs. Using a longitudinal pretest-posttest design, we will assess the intervention's impact at both the individual and community levels to evaluate the feasibility of this community-based, culturally informed approach. In addition, we will examine the feasibility of replicating the CoLLab Learning Health System in underserved communities nationwide.