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

在肯尼亚蒙巴萨实施科学工具以增加宫颈癌筛查的随机对照试验

• 批准号: 10166797
• 负责人: McKenna Claire Eastment
• 金额: $ 7.99万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-06 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166797
• 关键词: 21 year old; Address; Africa South of the Sahara; African; Age; Attention; Award; Biometry; Cancer Etiology; Career Mobility; Caring; Cervical Cancer Screening; Cessation of life; Client; Clinic; Clinical Trials; Cluster randomized trial; Cold Therapy; Collaborations; Collection; Communicable Diseases; Competence; Consolidated Framework for Implementation Research; Country; County; Cytology; Data Science; Development Plans; Diagnosis; Education; Environment; Epidemiology; Evaluation; Face; Failure; Family Planning; Female; Foundations; Goals; Guidelines; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; Health; Hospitals; Human Papillomavirus; Hypersensitivity; Incidence; Infrastructure; Institution; Instruction; Intervention; Kenya; Lesion; Letters; Life Expectancy; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Measurable; Medicine; Mentors; Mentorship; Methodology; Methods; Morbidity - disease rate; Outcome; Patients; Policies; Poverty; Procedures; Process; Public Health; Randomized; Randomized Controlled Trials; Reproducibility; Research; Research Design; Research Personnel; Research Project Grants; Research Proposals; Research Training; Resources; Standardization; Stress; System; Systems Analysis; Testing; Training; Training Programs; United States; Universities; Virus Diseases; Visual; Washington; Woman; Women' s Health; aging population; antiretroviral therapy; budget impact; cancer therapy; career; career development; cervical cancer prevention; cost; economic evaluation; evidence base; follow-up; global health; health literacy; human old age (65+); immune reconstitution; implementation research; implementation science; implementation tool; improved; insight; instructor; interest; lifetime risk; loop electrosurgical excision procedure; low and middle-income countries; mortality; premalignant; prevent; research and development; screening; screening guidelines; skills; success; tool

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.

抽象的 提案摘要：该提案支持为期 4 年的研究和培训计划，以使 Eastment 博士能够 作为女性领域的独立调查员和领导者，在职业生涯中取得实质性进展 健康和宫颈癌筛查的实施。她的目标是量化宫颈癌筛查护理 级联并了解适当筛选的相关性。然后她将进行整群随机 试验测试实施科学工具，即系统分析和改进方法（SAIA），以改进 肯尼亚蒙巴萨对艾滋病毒阳性和艾滋病毒阴性妇女进行宫颈癌筛查。预算影响 SAIA 分析将为蒙巴萨县卫生部 (DOH) 进行。 Eastment 博士的专业知识 在协调肯尼亚的研究中利用相同的实施科学工具为 这项拟议的计划。她的培训计划将包括研究设计、经济评估、 分析相关数据以及这些领域领导者的实施科学，利用 华盛顿大学（UW）卓越的研究和培训环境，以及长期的实力 与蒙巴萨县的长期合作。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以及她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。研究计划：宫颈癌是最常见的 撒哈拉以南非洲地区妇女的常见癌症，大多数宫颈癌死亡率发生在低收入和低收入人群 中等收入国家（LMIC）。高收入国家和中低收入国家之间的许多差异归因于差异 在筛选中。肯尼亚指南建议采用目视检查方法进行筛查，然后进行治疗 通过冷冻疗法和环形电外科切除术（LEEP）治疗癌前病变。实施 截至 2014 年，只有 14% 的肯尼亚妇女接受过宫颈癌筛查，这些情况很贫困。 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，我们将描述宫颈 癌症筛查护理级联，从识别 21-65 岁女性客户，到转介 在蒙巴萨县计划生育 (FP) 诊所对筛查结果呈阳性或可疑的客户进行随访。 在描述该级联的特征之后，我们将对筛选失败的相关因素进行分析 蒙巴萨县一年内 FP 客户出现宫颈癌的情况。目标 2 将测试 SAIA 是否 在 20 个 FP 诊所进行的整群随机试验中，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 来增加成本和预算影响 蒙巴萨县 FP 诊所的宫颈癌筛查。这项研究的结果有可能改善 宫颈癌筛查，并为蒙巴萨卫生部的政策提供信息，以实现财政上负责任的、循证的 宫颈癌筛查的方法。长期目标是降低宫颈癌死亡率并改善 女性健康。