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

摘要 宫颈癌（CC）几乎是完全可以预防与目前的技术，但它仍然是最常见的 癌症是东非妇女癌症死亡的最常见原因。CC是全球第四大 是妇女癌症发病率和死亡率的最常见原因，也是42 低收入和中等收入国家（LMICs），其中90%的CC死亡发生。为实现2018年世界卫生 世界卫生组织（世卫组织）呼吁采取行动，实现全球消除CC，迫切需要适应，实施， 并在中低收入国家推广有效的技术。在中低收入国家，预防CC的主要措施是单次就诊， 方法使用筛选和治疗（SVA-SAT）方法，使用乙酸（VIA）目视检查和消融 冷冻治疗以管理癌前病变。这是一种低成本的筛选方法， 与传统细胞学相比，失访。尽管VIA在人群中的有效性已得到证实， 在国家一级减少CC负担，估计肯尼亚30-49岁妇女的筛查率为16%， 这与世卫组织到2030年对35-45岁女性进行两次终生筛查的目标相去甚远。此外还有 SVA-SAT的保真度极低;高达70%的筛查阳性妇女没有接受治疗。低待遇- 手术率的下降归因于在低- 资源设置（例如，制冷剂气体、设备故障和治疗持续时间的供应链困难>10 min）。热消融（TA）是WHO在2019年推荐的，是一种有效和安全的替代方法， 冷冻疗法这种便携式设备可以用电力、电池或太阳能电池板充电，非常适合农村地区。 设置.然而，成功的不确定驱动因素对广泛传播和采用提出了挑战。 实施.我们的目标是开发和评估一个本地化的传播和实施- SVA-SAT与TA（SVA-SAT+TA）的空间站（D&I）战略，为国家扩大规模提供信息。我们的假设是 TA将通过SVA-SAT提高CC预防服务的可行性、采用率和可持续性， 冷冻疗法我们的多学科团队提出了一项为期五年的前瞻性、阶梯楔形、随机试验， 在肯尼亚中部10个生殖健康诊所实施SVA-SAT+TA。在目标1中，我们将合作 与多层次（诊所、县、国家）利益相关者一起制定可持续的D&I战略，以引入SVA- SAT+TA，有效地解释了客户端、提供商和系统输入的异质性。在目标2中， 将在肯尼亚的公共生殖健康诊所大规模实施并严格评估SVA-SAT+TA干预措施， RE-AIM（Reach，Effectiveness，Adoption，Implementation，and Maintenance）框架。在目标3中， 将比较SVA-SAT+TA与使用冷冻疗法的SVA-SAT的成本、成本效益和预算影响。 总之，该项目的成果将促进更广泛地实施和扩大循证 干预，SVA-SAT+TA，并提供必要的证据来指导政策，并作为CC的模型 在中低收入国家的背景下进行预防。

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.