Provider-initiated screening clinical breast examination and patient navigation in sub-Saharan Africa: protocol for an implementation mapping-based pilot study

Abstract

Abstract Background Breast cancer care in sub-Saharan Africa is characterised by delays in time to presentation, diagnosis, and treatment initiation, due to low health-seeking behaviour, lack of access to care, long wait times, and weak referral systems with limited use of evidence-based interventions such as routine breast cancer screening and patient navigation (PN) services. To address these issues, we plan to develop, pilot, and evaluate a set of implementation strategies to integrate provider-initiated clinical breast examination (CBE) and PN into routine clinical practice to support timely breast cancer diagnosis and treatment initiation. Methods We will conduct a pragmatic implementation pilot study in the four sub-Saharan African countries that make up the Network for Oncology Research in Africa (NORA) consortium: Ethiopia, South Africa, Nigeria, and Tanzania. The study will follow the implementation mapping (IM) process, drawing on theory, evidence, and stakeholders’ input to develop and evaluate a set of implementation strategies. Our target evidence-based intervention will be provider driven breast cancer screening via opportunistic, clinic-based CBE for all eligible patients and subsequent PN support for women with abnormal exams through diagnosis evaluation and initiation of treatment. All four countries will begin by conducting independent mixed-methods needs assessments structured according to the Consolidated Framework for Implementation Research to identify contextual barriers and implementation determinants. Working with local stakeholders, defined performance objectives and identified determinants will be used to select evidence-based implementation strategies. The set of strategies will then be implemented and iteratively evaluated in two phases, guided by the RE-AIM framework. Our primary implementation outcomes will address reach (the proportion of CBE uptake) and secondary implementation outcomes will address adoption by providers and implementation fidelity. Preliminary effectiveness outcomes will include stage distribution of newly diagnosed breast cancers and diagnostic and treatment intervals. Data sources will include existing medical records, internal study clinical records, structured facility resource surveys, patient and provider surveys, observational checklists, and qualitative interviews and focus group discussions. Discussion This multi-country implementation study protocol demonstrates a structured, theory-informed approach to develop, pilot, and evaluate implementation strategies for breast cancer screening in diverse health care settings. If the intervention succeeds, findings from this pilot will inform design of future hybrid effectiveness–implementation studies, readiness for potential national scale-up, and adaptation to similar low and middle-income settings. Protocol registration number The protocol is registered at clinicaltrials.gov: NCT07023198: registered 01 April, 2026, https://clinicaltrials.gov/study/NCT07023198 .