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

消除宫颈癌：在肯尼亚实施和扩大单次就诊、筛查和治疗的热消融方法，以提供可持续的宫颈癌预防服务

• 批准号: 10491699
• 负责人: Sarah Odell Gimbel
• 金额: $ 52.56万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491699
• 关键词: Ablation; Acetic Acids; Adoption; Aftercare; Age; Cancer Burden; Cancer Control; Cancer Etiology; Cessation of life; Charge; Client; Clinic; Clinical effectiveness; Cold Therapy; County; Cytology; Data; Decision Analysis; Devices; Dissemination and Implementation; Eastern Africa; Educational workshop; Effectiveness; Electricity; Equipment; Equipment Failure; Evaluation; Evidence based intervention; Feedback; Gases; Goals; Head; Health; Heterogeneity; Human Papillomavirus; Incidence; Intervention; Interview; Kenya; Learning; Lesion; Logistics; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methods; Modeling; Nurses; Patients; Policies; Population; Process Measure; Provider; Reach Effectiveness Adoption Implementation and Maintenance; Reproductive Health; Resource-limited setting; Safety; Science; Services; System; Techniques; Technology; Testing; Thermal Ablation Therapy; Training; Update; Visit; Visual; Woman; Work; World Health Organization; Zambia; aged; base; budget impact; cervical cancer prevention; cost; cost effectiveness; cost estimate; dissemination strategy; experience; follow-up; implementation intervention; implementation science; implementation strategy; improved; intervention effect; low and middle-income countries; member; microcosting; mortality; multidisciplinary; opportunity cost; patient population; population based; portability; premalignant; prevention service; programs; prospective; randomized trial; routine care; rural setting; scale up; screening; secondary analysis; treatment duration; uptake

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.

抽象的 宫颈癌（CC）几乎完全可以通过当前技术来预防，但是它仍然是最常见的 癌症和东非妇女癌症死亡的最常见原因。在全球范围内，CC是第四 妇女癌症发病率和死亡率的最常见原因，以及癌症的主要原因42 低收入和中等收入国家（LMIC），其中90％的CC死亡发生。实现2018年世界健康 组织（WHO）呼吁全球CC消除行动，迫切需要适应，实施， 和扩大LMIC中的有效技术。 LMIC中CC预防的主要阶段一直是一次性 使用屏幕和治疗方法（SVA-SAT）方法，使用乙酸（VIA）和烧蚀的视觉检查 通过冷冻疗法治疗以管理癌前病变。这是一种低成本的筛选方法，可最大程度地减少 与传统细胞学相比，随访的损失。尽管Via对Popula的有效性很高 CC负担的减少，肯尼亚30-49岁妇女的估计筛查吸收率为16％， 到2030年，WHO的目标是70％两次的千年来筛查35-45岁的女性。 SVA-SAT的极低忠诚度；多达70％的屏幕阳性女性未接受治疗。低点 MENT率归因于在低 - 中实施冷冻疗法的程序和后勤挑战 资源设置（例如，制冷剂气体，设备故障和处理时间> 10的供应链困难 最小）。 WHO在2019年推荐热消融（TA），是一种有效且安全的替代品 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，这是乡村的理想选择 设置。但是，不确定的驱动因素挑战了广泛的传播和收养 执行。我们的目标是开发和评估本地上下文化的传播和实施 与TA（SVA-SAT+TA）SVA-SAT的Tation（D＆I）策略，以告知国家规模。我们的假设是 TA将通过SVA-SAT提高CC预防服务的可行性，采用和可持续性 冷冻疗法。我们的跨学科团队提出了五年的预期，阶梯式，随机试验的 在肯尼亚中部十个生殖健康（RH）诊所中实施SVA-SAT+TA。在AIM 1中，我们将合作 通过多层次（诊所，县，国家）利益相关者制定可持续的D＆I战略，以引入SVA- SAT+TA有效地解释了客户，提供商和系统输入的异质性。在AIM 2中，我们 将在肯尼亚的公共RH诊所进行验证并严格评估SVA-SAT+TA干预措施 Re-Aim（触及，有效性，采用，实施和维护）框架。在AIM 3中，我们 将使用冷冻疗法比较SVA-SAT+TA对SVA-SAT的成本，成本效益和预算影响。 总之，该项目的结果将改善基于证据的更广泛的实施和扩大规模 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LMICs环境中的预防。