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Peer-reviewedCC BYImplementation science communications

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

1 more authors
12 affiliations
  1. 1Network for Oncology Research in Africa (NORA), Global and Planetary Health Working Group, Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
  2. 2Department of Epidemiology & Biostatistics, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.
  3. 3Department of Public Health, College of Health Sciences, Debre Tabor University, Debre Tabor, Ethiopia.
  4. 4International Research Center of Excellence, Institute of Human Virology, Abuja, Nigeria.
  5. 5Department of Oncology, School of Medicine, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia.
  6. 6South African Medical Research Council Aging African Adult Research Unit, University of Witwatersrand, Johannesburg, South Africa.
  7. 7Kilimanjaro Clinical Research Institute, Moshi, Tanzania.
  8. 8School of Medicine, KCMC University, Moshi, Tanzania.
  9. 9Department of Gynecology, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
  10. 10Yale Cancer Center, Yale University, New Haven, CT, USA.
  11. 11Network for Oncology Research in Africa (NORA), Global and Planetary Health Working Group, Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. [email protected].
  12. 12Department of Epidemiology & Biostatistics, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. [email protected].

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 .

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BibTeX
@article{tesfaw2026providerinitiated,
  title = {{Provider-initiated screening clinical breast examination and patient navigation in sub-Saharan Africa: protocol for an implementation mapping-based pilot study.}},
  author = {Aragaw Tesfaw and Elima Jedy Agba and Edom Seife and Sara Debebe and Eyerusalem Getachew and Muluken Gizaw and Maureen Joffe and Adamu Addissie and Alex Mremi and Blandina Theophil Mmbaga and Eva Johanna Kantelhardt and Daniel S O'Neil and Sefonias Getachew},
  journal = {Implementation science communications},
  year = {2026},
  month = jul,
  doi = {10.1186/s43058-026-01029-3},
  url = {https://europepmc.org/article/MED/42919438},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Provider-initiated screening clinical breast examination and patient navigation in sub-Saharan Africa: protocol for an implementation mapping-based pilot study.
AU  - Aragaw Tesfaw
AU  - Elima Jedy Agba
AU  - Edom Seife
AU  - Sara Debebe
AU  - Eyerusalem Getachew
AU  - Muluken Gizaw
AU  - Maureen Joffe
AU  - Adamu Addissie
AU  - Alex Mremi
AU  - Blandina Theophil Mmbaga
AU  - Eva Johanna Kantelhardt
AU  - Daniel S O'Neil
AU  - Sefonias Getachew
PY  - 2026
DA  - 2026/07/01
JO  - Implementation science communications
DO  - 10.1186/s43058-026-01029-3
UR  - https://europepmc.org/article/MED/42919438
AB  - 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 .
SN  - 2662-2211
ER  -