A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda

项目总结 宫颈癌(CC)是乌干达妇女癌症相关死亡的主要原因，乌干达有一个 世界上发病率最高的国家之一。使用醋酸(VIA)CC筛查的循证目视检查是 免费或低成本，但约5%的乌干达妇女曾筛查过CC，约80%患有晚期癌症 在启动护理时。根据网络传播和社会影响的理论，以及已知的患者层面， 非结构性障碍和CC筛查的促进者，我们开发了同行领导的7次会议小组 宫颈癌预防干预游戏规则改变者(GC-CCP)--患者层面的实施 增加CC筛查的策略。GC-CCP使最近筛查CC的女性能够 通过传播CC知识，消除谣言，鼓励在其社交网络中对女性进行筛查， 减少CC柱头。一项由R21资助的试点随机对照试验(RCT)显示， 增加了对之前未筛选的社交网络成员(即更改的成员)的CC筛选。这些结果， 而我们的多学科团队在成功协作方面的良好记录，将此应用程序定位为 对乌干达的CC预防和控制产生强烈影响，这可以推广到其他低到 中等收入国家环境。我们提出了一种GC-CCP的混合型1型RCT来评估其有效性 通过筛选、实施和可持续性增加对循证证据的接受。研究设计 以探索、准备、实施和持续(EPIS)实施科学为指导 框架。探索：这一阶段包括完成的试点和研究地点选择(两个公开的，两个 私人的，城市和农村地区各有一人)。准备：在第一年，我们将确定和补救诊所- 以及提供商级别的障碍，以确保很好地获得和交付CC筛查服务。实施：在 每个站点，40名接受CC筛查的女性将作为指数参与者(n=160指数)登记在随机对照试验中，并将 随机到干预或等待名单对照。每个索引将招募最多三个(1级)更改者(n~440 ALTERS)未筛查CC的基线；这些索引和ALTER参与者将在 6个月和12个月。在6个月，每个修改者将招募最多两个(2级)修改者(N~800个修改者) 电话采访。维持：在登记的指标参与者接受干预后，每个诊所将 继续实施GC-CCP(客户未参加RCT)，为期2.5年，并接受培训 并将监督任务转移到诊所工作人员。使用RE-AIM框架，我们将评估以下项目的参与度 GC-CCP和CC宣传(REACH)，改变CC筛查(有效性)，采用常规护理， 实施结果(可接受性、保真度、可行性、成本)和维护。创新、可持续 GC-CCP等实施战略对于增加对CC筛查的需求至关重要。

PROJECT SUMMARY Cervical cancer (CC) is the leading cause of cancer-related deaths among women in Uganda, which has one of the world’s highest incidence rates. Evidence-based visual inspection with acetic acid (VIA) CC screening is free or low cost, yet ~ 5% of Ugandan women have ever screened for CC, and ~80% have advanced cancer when initiating care. Drawing on theories of network diffusion and social influence, and known patient-level, non-structural barriers and facilitators of CC screening, we developed the peer-led, 7-session group intervention Game Changers for Cervical Cancer Prevention (GC-CCP), a patient-level implementation strategy to increase CC screening. GC-CCP empowers women who have recently screened for CC to encourage screening among women in their social networks by disseminating CC knowledge, dispelling myths, and reducing CC stigma. An R21-funded pilot randomized controlled trial (RCT) revealed dramatic effects of increased CC screening among previously unscreened social network members (i.e., alters). These results, and our multidisciplinary team’s strong track record of successful collaboration, positions this application to make a strong impact on CC prevention and control in Uganda, which could be generalizable to other low to middle income country settings. We propose a hybrid type 1 RCT of GC-CCP to assess its effectiveness for increasing uptake of evidence-based VIA screening, and implementation and sustainability. The study design is guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) implementation science framework. Exploration: This phase consisted of the completed pilot and study site selection (two public, two private, one each in an urban and rural location). Preparation: In year 1, we will identify and remediate clinic- and provider-level barriers to ensure good access to and delivery of CC screening services. Implementation: At each site, 40 women screened for CC will enroll in the RCT as index participants (n=160 index) and be randomized to the intervention or wait-list control. Each index will recruit up to three (1st degree) alters (n~440 alters) at baseline who have not screened for CC; these index and alter participants will be followed up at months 6 and 12. At month 6, these alters will each recruit up to two (2nd degree) alters (n ~800 alters) for a phone interview. Sustainment: After enrolled index participants receive the intervention, each clinic will continue to implement GC-CCP (with clients not enrolled in the RCT) for an additional 2.5 years, with training and supervision tasks transferred to clinic staff. Using the RE-AIM framework, we will evaluate engagement in GC-CCP and CC advocacy (reach), alter CC screening (effectiveness), adoption into usual care, implementation outcomes (acceptability, fidelity, feasibility, cost), and maintenance. Innovative, sustainable implementation strategies such as GC-CCP are critical to increase demand for CC screening.