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

项目摘要 – 项目 3 大多数宫颈癌病例发生在未经筛查和筛查不足的女性中。增加策略 因此，对这些女性进行筛查，包括 HPV 自我检测，被认为是最有效的方法。 重要的宫颈癌筛查研究重点。 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。国际研究多次表明，许多 未筛查和未筛查的女性会在家中进行 HPV 自检，并通过邮寄方式寄回，最近 美国（US）的努力，包括我们自己的工作，已经确立了实施此类措施的可行性 基于邮件的程序。该研究领域的下一步重要的一步是检验有效性和 在美国实施大型、基于邮件的 HPV 自检计划。 拟议项目的总体目标是确定多层次的有效性和实施情况 宫颈癌筛查干预措施，包括针对未筛查和筛查不足的 HPV 自检 来自阿巴拉契亚地区的女性，该地区的宫颈癌差异长期存在。干预措施将包括 基于邮件的 HPV 自检（患者级别）、医疗保健提供者有关 HPV 自检的教育课程 （提供者级别），以及针对最初未返回 HPV 自检或进行了 HPV 检测的女性的患者导航 随后检测出高风险（即致癌）HPV 感染呈阳性（系统级）。拟议的研究将 包括 1180 名未筛查和未筛查的 30-64 岁阿巴拉契亚女性并予以实施 作为基于综合卫生系统的宫颈癌预防计划“提高对 阿巴拉契亚的宫颈癌预防服务。” 重要的是，拟议的项目将采用有效性与实施混合的方法，以便 评估干预措施的有效性和实施情况。具体目标将针对每个 建议实施研究的结果类型（服务、实施和客户结果）：目标 1（服务结果）将决定多层次干预在增加颈椎病方面的有效性。 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、 干预措施的可持续性和成本效益；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。每个目标都将进行重大研究 共同做出的贡献，将成为最具创新性和最全面的 HPV 自检工作之一 迄今为止在美国。随着 HPV 自检在美国继续成为宫颈癌筛查策略， 这些调查结果将为干预措施的有效性和实施提供证据基础 对于指导未来 HPV 自检计划和宫颈癌筛查政策非常有价值。

PROJECT SUMMARY – PROJECT 3 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.