Leveraging community health workers for the promotion of Breast Cancer Awareness and Timely Help-Seeking Behaviour (BreCATH-B study), among underserved rural population in Kenya: a protocol for a hybrid type II cluster randomised controlled trial

Female breast cancer (FBC) is the world’s most diagnosed cancer and the leading or second leading cause of female cancer-related deaths in 95% of the countries. In Kenya, it is the most diagnosed cancer with 7, 243 (16.2%) new cases reported in 2023. Advanced-stage FBC diagnosis remains the primary driver of poor outcomes despite existing evidence on the effectiveness of early diagnosis interventions in promoting early-stage diagnosis and improved outcomes. There is paucity of evidence on which implementation strategies would be most appropriate to implement early diagnosis interventions to improve outcomes in Kenya. We aim to co-create and evaluate implementation strategies to promote FBC awareness, uptake of clinical breast examination, and efficiency of the referral system. Breast Cancer Awareness and Timely Help-Seeking Behaviour (BreCATH-B) hybrid type II effectiveness-implementation trial utilizes cluster randomized controlled design. We will evaluate both the effectiveness and implementation outcomes of community health care workers (CHWs) and primary health care workers (PHCWs)-led breast health education and AI-assisted clinical decision support and referral system (AI-Assisted CDSRS). CHWs in the intervention arm will receive training on FBC awareness, while PHCWs will receive training on clinical breast examination (CBE). Both implementers will receive training on the AI-Assisted CDSRS. The control arm will continue delivering usual care. The co-primary effectiveness outcomes are level of utilization of CBE services and Women’s FBC symptoms awareness. Secondary effectiveness outcomes include level of FBC stigma, lengths of patient and primary care intervals, FBC stage at diagnosis, PHCWs proficiency in conducting CBE, and PHCWs and CHWs proficiency in using AI-Assisted CDSRS. The primary implementation outcomes are reach, adoption, implementation and maintenance. Secondary implementation outcomes include health equity and economic evaluations (Cost-effectiveness analysis, equity measure, incremental cost-effectiveness analysis, impact analysis). The BreCATH-B trial will test effectiveness of an early diagnosis FBC intervention on women’s health outcomes, while at the same time evaluating implementation strategies among an underserved rural population in primary care settings in Kenya. The trial is aligned with global and national (Kenya) FBC control priority for low- and middle-income (LMIC) settings, which emphasizes early diagnosis. Results from the trial will offer lessons how to implement FBC-related evidence-based intervention to reverse the increasing burden of advanced-stage diagnosis and improve FBC outcomes in LMIC settings. Pan African Clinical Trial Registry, PACTR202607894798212, 1 July 2026.