Towards Cervical cancer elimination: Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services in Kenya

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ABSTRACT Cervical cancer (CC) is almost entirely preventable with current technologies, yet, it remains the most common cancer and the most common cause of cancer death among women in Eastern Africa. Globally, CC is the 4th most common cause of cancer incidence and mortality among women, and the leading cause of cancer in 42 low- and middle- income countries (LMICs), where 90% of CC deaths occur. To achieve the 2018 World Health Organization (WHO)'s call to action towards global CC elimination, there is an urgent need to adapt, implement, and scale-up effective technologies in LMICs. The mainstay of CC prevention in LMICs has been the single-visit approach using screen-and-treat (SVA-SAT) method, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. It is a low-cost screening approach and it minimizes loss to follow-up compared to the traditional cytology. Despite well-established effectiveness of VIA on popula- tion-level reduction in CC burden, the estimated screening uptake among women aged 30-49 in Kenya is 16%, far from the WHO's target of 70% twice-lifetime screening of women ages 35-45 by 2030. Additionally, there is extremely low fidelity of SVA-SAT; up to 70% of screen-positive women do not receive treatment. The low treat- ment rate has been attributed to programmatic and logistical challenges of implementing cryotherapy in low- resource settings (e.g., supply chain difficulties of refrigerant gas, equipment failure, and treatment duration >10 min). Thermal ablation (TA), was recommended by the WHO in 2019 and is an effective and safe alternative to cryotherapy. The portable device can be charged with electricity, batteries or solar panels, which is ideal for rural settings. However, wide dissemination and adoption have been challenged by undefined drivers of successful implementation. Our objective is to develop and evaluate a locally contextualized dissemination and implemen- tation (D&I) strategy for SVA-SAT with TA (SVA-SAT+TA) to inform national scale-up. Our hypothesis is that TA will enhance the feasibility, adoption, and sustainability of CC prevention services via SVA-SAT, compared to cryotherapy. Our multidisciplinary team proposes five-year prospective, stepped-wedge, randomized trial to implement SVA-SAT+TA in ten reproductive health (RH) clinics in central Kenya. In Aim 1, we will collaborate with multi-level (clinic, county, national) stakeholders to develop a sustainable D&I strategy to introduce SVA- SAT+TA that effectively accounts for the heterogeneity of the client, provider and system inputs. In Aim 2, we will deliver and rigorously evaluate the SVA-SAT+TA intervention at scale in public RH clinics in Kenya, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. In Aim 3, we will compare the cost, cost-effectiveness and budget impact of SVA-SAT+TA to SVA-SAT using cryotherapy. Together, the results from this project will improve wider implementation and scale-up of an evidence-based intervention, SVA-SAT+TA, and provide the necessary evidence to guide policy and serve as a model for CC prevention in the LMICs context.