Project 3: A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening among Women in Appalachia

项目 3：多级 HPV 自检干预措施，以提高阿巴拉契亚地区妇女的宫颈癌筛查率

• 批准号: 10268454
• 负责人: Paul L Reiter
• 金额: $ 1.01万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-11 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10268454
• 关键词: Address; Advisory Committees; Age; Appalachian Region; Appointment; Area; Attitude; Australia; Belief; Caring; Cervical Cancer Screening; Characteristics; Client; Clinic; Country; Cytology; Devices; Education; Effectiveness; Effectiveness of Interventions; Focus Groups; Future; Geographic Locations; Goals; Guidelines; HPV-High Risk; Health Personnel; Health system; Healthy People 2020; Home environment; Human Papillomavirus; Human papilloma virus infection; Integrated Health Care Systems; International; Intervention; Intervention Trial; Knowledge; Malignant neoplasm of cervix uteri; Mission; Netherlands; Oncogenic; Outcome; Pap smear; Patients; Pilot Projects; Prevention program; Preventive service; Provider; Public Health; Reporting; Research; Research Priority; Sampling; Scientific Advances and Accomplishments; Service delivery model; Services; Surveys; System; Testing; United States; Use Effectiveness; Woman; Women' s Health; Work; barrier to care; base; cancer health disparity; cervical cancer prevention; cervicovaginal; cost effective; cost effectiveness; effectiveness implementation study; evidence base; follow-up; health organization; high risk; implementation research; improved; innovation; insight; patient oriented; prevention service; primary outcome; programs; rurality; satisfaction; screening; screening guidelines; screening policy; screening program; uptake

Most cases of cervical cancer occur among unscreened and under screened women. Strategies to increase screening among these women, including HPV self-testing, have therefore been identified as the most important cervical cancer screening research priority. HPV self-testing involves women using a device to collect their own cervicovaginal sample for HPV testing. International studies have repeatedly shown that many unscreened and under screened women will use an HPV self-test at home and return it by mail, and recent efforts in the United States (US), including our own work, have established the feasibility of implementing such mail-based programs. An important next step in this field of research is to examine the effectiveness and implementation of a large, mail-based HPV self-testing program in the US. The overall goal of the proposed project is to determine the effectiveness and implementation of a multi-level cervical cancer screening intervention that features HPV self-testing for unscreened and under screened women from Appalachia, a region with longstanding cervical cancer disparities. The intervention will include mail-based HPV self-testing (patient-level), healthcare provider education sessions about HPV self-testing (provider-level), and patient navigation for women who do not initially return their HPV self-test or who subsequently test positive for a high-risk (i.e., oncogenic) HPV infection (system-level). The proposed study will include 1180 unscreened and under screened Appalachian women who are ages 30-64 and be implemented as part of the integrated health system-based cervical cancer prevention program “Improving Uptake of Cervical Cancer Prevention Services in Appalachia.” Importantly, the proposed project will take an effectiveness-implementation hybrid approach that will allow for the assessment of both intervention effectiveness and implementation. Specific aims will address each outcome type (service, implementation, and client outcomes) recommended for implementation research: Aim 1 (service outcomes) will determine the effectiveness of the multi-level intervention in increasing cervical cancer screening (primary outcome); Aim 2 (implementation outcomes) will assess the acceptability, fidelity, sustainability, and cost-effectiveness of the intervention; and Aim 3 (client outcomes) will determine satisfaction with the intervention at the patient-, provider-, and system-level. Each aim will make a significant research contribution and, taken together, will be one of the most innovative and comprehensive HPV self-testing efforts to date in the US. As HPV self-testing continues to emerge as a cervical cancer screening strategy in the US, these findings will provide an evidence base on both intervention effectiveness and implementation that will be highly valuable in guiding future HPV self-testing programs and cervical cancer screening policies.

大多数宫颈癌病例发生在未筛查和筛查不足的妇女中。战略增加 因此，在这些妇女中进行筛查，包括HPV自我检测，已被确定为最有效的方法。 宫颈癌筛查研究的重要优先事项。HPV自我检测涉及女性使用设备， 收集自己的宫颈阴道样本进行HPV检测。国际研究一再表明，许多 未经筛查和筛查不足的妇女将在家中进行HPV自检，并通过邮件寄回， 美国的努力，包括我们自己的工作，已经确定了实施这种方法的可行性。 基于邮件的程序。这一研究领域的一个重要的下一步是检查有效性， 在美国实施一项大型的、基于邮件的HPV自我检测计划。 拟议项目的总体目标是确定一个多层次的有效性和实施 宫颈癌筛查干预措施，包括对未筛查和筛查不足的人群进行HPV自我检测 来自阿巴拉契亚的妇女，这是一个长期存在宫颈癌差异的地区。干预措施将包括 基于邮件的HPV自我检测（患者级别），医疗保健提供者关于HPV自我检测的教育课程 （提供者级别），以及针对最初未返回HPV自检结果或 随后检测为高风险阳性（即，致癌）HPV感染（系统水平）。拟定的研究将 包括1180名年龄在30-64岁未筛查和筛查不足的阿巴拉契亚妇女， 作为基于卫生系统的宫颈癌综合预防方案的一部分， 阿巴拉契亚的宫颈癌预防服务。” 重要的是，拟议的项目将采取有效性-实施混合方法， 评估干预措施的有效性和执行情况。具体目标将针对每个 建议用于实施研究的成果类型（服务、实施和客户成果）：目标 1（服务结果）将决定多层次干预在增加宫颈癌方面的有效性。 癌症筛查（主要结果）;目标2（实施结果）将评估可接受性，保真度， 目标3（客户成果）将决定满意度 在患者、提供者和系统层面进行干预。每一个目标都将进行有意义的研究 这将是最具创新性和最全面的HPV自我检测工作之一 到目前为止，在美国。随着HPV自我检测继续成为美国宫颈癌筛查策略， 这些发现将为干预措施的有效性和实施提供证据基础， 对指导未来的HPV自我检测计划和宫颈癌筛查政策具有很高的价值。