Integrated Community-Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya: Protocol for a Pragmatic Randomized Controlled Trial.

Background: Kenyan women experience a high burden from breast and cervical cancers. Screening can result in earlier diagnosis, but its uptake is extremely low. The proportion of women up to date with screenings per guidelines is low, implying that interactions between providers and women are reduced. Objective: We will test complementary strategies in community and clinic settings that can improve community-clinic linkages and address multilevel barriers. We aim to conduct randomized trials to compare a C3Link (cancer community-clinic linkage) program with enhanced usual care. We will (1) conduct a cluster randomized trial to assess the short-term and longer-term impact of the C3Link package of strategies, (2) use a mixed methods approach to assess multilevel implementation outcomes, and (3) perform cost-effectiveness and return on investment analysis. Methods: We will create the C3Link package aimed at increasing breast and cervical cancer screenings, and adopt a study design to assess and evaluate sustainability in 3 counties: Machakos, Nakuru, and Nyeri. Three noncontiguous communities for each of the 9 study clinics (3 per county) will be randomly assigned to one of the study arms using the R (R Foundation) program. The intensity of the strategies varies from low (awareness campaign for the enhanced usual care arm), to medium (C3Link Core arm with study community health worker-led group education and study community health worker-embedded clinic teams enhanced with practice facilitation), and to high (C3Link Plus arm with C3Link Core and a predetermined sequence of individual strategies). Women aged 30 to 55 years (1 per household) will be eligible to participate and could select a support person for inclusion. Trained data collectors will conduct surveys for women, their support persons, and from providers in the clinics using questionnaires, tracking tools, and focus group discussion guides. We will collect data and conduct interviews and focus groups to identify underlying moderating factors associated with the successful implementation of strategies. We will use implementation science methods to evaluate the effectiveness, implementation outcomes, and cost-effectiveness of the C3Link program compared with the enhanced usual care. Results: This study was funded in July 2022, received institutional review board approvals in November 2022 (United States) and June 2023 (Kenya). It was registered on ClinicalTrials.gov in September 2024. Enrollment of this study's cohort began in September 2024 and was concluded in November 2024. We began implementing the interventions in 2025 and will report on our primary end points on screening uptake and follow-up in 2027 based on 24-month follow-up data. Conclusions: The C3Link Program is expected to yield better screening and follow-up outcomes than the control but will require more resources. Incremental cost-effectiveness of each strategy in the outlined sequence will be determined.