Randomized controlled trial of an implementation science tool to increase cervical cancer screening in Mombasa, Kenya

摘要 提案摘要：该提案支持一项为期4年的研究和培训计划，以使Eastment博士能够 在妇女问题领域的独立调查员和领导者的职业生涯中取得实质性进展 健康和子宫颈癌检查。她的目标是量化宫颈癌筛查护理 级联并了解适当筛查的相关性。然后她将进行一个随机分组 试验测试实施科学工具，系统分析和改进方法（SAIA），以提高 在肯尼亚蒙巴萨为艾滋病毒阳性和阴性妇女进行宫颈癌筛查。预算影响 将为蒙巴萨县卫生部（DOH）进行SAIA分析。伊斯蒂博士的专业知识 在协调肯尼亚利用相同的实施科学工具的研究提供了坚实的基础， 这个提议的计划。她的培训计划将包括研究设计、经济评估、 相关数据分析，以及这些领域领导者的实施科学， 华盛顿大学（UW）杰出的研究和培训环境，以及长期的 与蒙巴萨县长期合作。她收集了来自华盛顿大学医学系的导师， 生物统计学、流行病学和全球健康，沿着她与来自蒙巴萨县的合作者，渴望 指导和支持Eastment博士的项目和职业发展。宫颈癌是一种常见的恶性肿瘤。 在撒哈拉以南非洲的妇女中，宫颈癌是一种常见的癌症，大多数宫颈癌死亡率低， 中等收入国家（LMIC）。高收入国家和低收入国家之间的许多差距是由于 在筛选中。肯尼亚的指南建议用目视检查方法进行筛查，然后治疗 冷冻治疗和环形电切除术（LEEP）治疗癌前病变。执行 这些都是穷人，截至2014年，只有14%的肯尼亚妇女接受过宫颈癌筛查。到 为了解决这一实施差距，本申请提出了三个目标。在目标1中，我们将描述颈椎 癌症筛查护理级联，从确定21-65岁的女性客户，到转诊， 在蒙巴萨州的计划生育诊所对筛查呈阳性或可疑的客户进行跟踪。 在对这一级联进行表征之后，我们将对筛选失败的相关因素进行分析， 在蒙巴萨县一年期间，FP客户中的宫颈癌。目标2将测试SAIA是否 在20家FP诊所进行的随机分组试验中，与常规程序相比，增加了宫颈癌筛查 在蒙巴萨县。最后，在目标3中，我们将确定使用SAIA来增加 在蒙巴萨州计划生育诊所进行宫颈癌筛查。这项研究的结果有可能改善 宫颈癌筛查，并告知蒙巴萨卫生部的政策， 子宫颈癌筛查的方法。长期目标是降低宫颈癌死亡率， 妇女的健康。

ABSTRACT Summary of Proposal: This proposal supports a 4-year research and training program to allow Dr. Eastment to make substantial progress toward a career as an independent investigator and leader in the field of women’s health and cervical cancer screening implementation. She aims to quantify the cervical cancer screening care cascade and understand the correlates of appropriate screening. She will then conduct a cluster randomized trial to test an implementation science tool, the Systems Analysis and Improvement Approach (SAIA), to improve cervical cancer screening for both HIV-positive and HIV-negative women in Mombasa, Kenya. A budget impact analysis of SAIA will be performed for Mombasa County Department of Health (DOH). Dr. Eastment’s expertise in coordinating studies in Kenya utilizing the same implementation science tool provides a strong foundation for this proposed plan. Her training program will include further instruction in study design, economic evaluations, analysis of correlated data, and implementation science from leaders in these fields, leveraging on the outstanding research and training environments at the University of Washington (UW), and the strength of long- term collaborations with Mombasa County. Her collection of mentors from the UW Departments of Medicine, Biostatistics, Epidemiology, and Global health, along with her collaborators from Mombasa County, are eager to mentor and support Dr. Eastment’s project and career development. Research Plan: Cervical cancer is the most common cancer in women in sub-Saharan Africa, and the majority of cervical cancer mortality occur in low and middle income countries (LMICs). Many of the disparities between high and LMICs are attributed to differences in screening. Kenyan guidelines recommend screening with visual inspection methods followed by treatment of pre-cancerous lesions with cryotherapy and loop electrosurgical excision procedure (LEEP). Implementation of these are poor with only 14% of Kenyan women ever having been screened for cervical cancer as of 2014. To address this implementation gap, this application proposes three aims. In Aim 1, we will describe the cervical cancer screening care cascade, from identification of female clients age 21-65 years old, through referral for follow-up of clients with positive or suspicious screens, in family planning (FP) clinics in Mombasa County. Following characterization of this cascade, we will conduct an analysis of correlates of failure to screen for cervical cancer in FP clients seen over a one-year period in Mombasa County. Aim 2 will test whether SAIA increases cervical cancer screening compared to usual procedures in a cluster randomized trial in 20 FP clinics in Mombasa County. Finally, in Aim 3, we will determine the cost and budget impact of using SAIA to increase cervical cancer screening in FP clinics in Mombasa County. The results of this study have the potential to improve cervical cancer screening, and inform policy in the Mombasa DOH for a fiscally responsible evidenced-based approach for cervical cancer screening. The long-term goal is to decrease cervical cancer mortality and improve women’s health.