mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in western Kenya

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Abstract Cervical cancer is the most common cancer among women in many low- and middle-income countries, including Kenya. This is mainly due to the lack of screening, which remains the cornerstone of prevention for the over one hundred million reproductive-aged women who fall outside the target age group or live in countries where the human papillomavirus (HPV) vaccination is not available. While HPV-based screening has the potential to be incorporated into simplified protocols, the laboratory testing component requires programs to have capacity to track specimens, results and patient follow-up, which can be a challenge in settings with limited healthcare infrastructure and no electronic medical records. Further, low baseline knowledge of HPV and cervical cancer risk in the community is associated with low rates of screening and follow-up, making effective outreach and education a key component of screening programs. This work is often done by community health volunteers (CHVs) with limited content-specific training. We propose to fill these gaps through an integrated digital platform that includes a mobile app (mSaada) that supports CHVs with patient and specimen tracking and follow-up, and counseling and protocol support. In the R21 phase of this project, we will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot study to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness and implementation factors. We will carry out a six-month pilot in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a cluster-randomized clinical trial (c-RCT) to determine effectiveness of mSaada. In the R33 phase of the project, we will use a hybrid implementation effectiveness design to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. We anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.