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)几乎完全可以用现有技术预防，然而，它仍然是最常见的 癌症是东非妇女最常见的癌症死亡原因。在全球范围内，CC排名第四 女性癌症发病率和死亡率的最常见原因，以及42%的主要癌症原因 低收入和中等收入国家(LMIC)，90%的CC死亡发生在那里。实现2018年世界卫生目标 世界卫生组织(世卫组织)S呼吁采取行动，实现全球消除CC，迫切需要适应、执行、 以及在LMIC中扩大有效技术。LMICs预防CC的主要手段是单次访问 采用筛选和治疗(SVA-SAT)方法，使用醋酸目视检查(VIA)和消融 用冷冻治疗来处理癌前病变。这是一种低成本的筛选方法，它最大限度地减少了 与传统细胞学相比失访。尽管VIA在人群中的有效性是公认的- 降低CC负担，肯尼亚30-49岁妇女的筛查摄取率估计为16%， 世界卫生组织的目标是到2030年对35-45岁的女性进行两次终身筛查，比例为70%。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。最低的待遇- 成功率被归因于在低剂量冷冻治疗中实施冷冻治疗的方案和后勤挑战。 资源设置(例如，制冷剂气体的供应链困难、设备故障和处理持续时间&gt；10 Min)。热消融(TA)，是世界卫生组织于2019年推荐的，是一种有效且安全的替代方法 冷冻疗法。便携式设备可以用电力、电池或太阳能电池板充电，这是农村地区的理想选择 设置。然而，广泛的传播和采用受到了成功的未知驱动因素的挑战 实施。我们的目标是发展和评估当地的背景传播和实施- SVA-SAT与TA(SVA-SAT+TA)的测试(D&I)战略，以告知全国推广。我们的假设是 相比之下，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 到冷冻疗法。我们的多学科团队建议进行为期五年的前瞻性、阶梯式、随机试验，以 在肯尼亚中部的十家生殖健康(RH)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)的利益相关者一起制定可持续的研发战略，以引入SVA- SAT+TA，有效地说明了客户端、提供商和系统输入的异构性。在目标2中，我们 将在肯尼亚的公共生殖健康诊所提供并严格评估SVA-SAT+TA干预措施，使用 RE-AIM(REACH、有效性、采用、实施和维护)框架。在目标3中，我们 将比较SVA-SAT+TA和使用冷冻疗法的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的实施和扩大以证据为基础的 干预，SVA-SAT+TA，并提供必要的证据来指导政策并作为CC的典范 低收入国家背景下的预防。

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.