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

乌干达宫颈癌预防游戏规则改变者的混合实施-有效性试验

• 批准号: 10718609
• 负责人: Laura M Bogart
• 金额: $ 63.75万
• 依托单位: RAND CORPORATION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-08 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718609
• 关键词: Acetic Acids; Adoption; Advanced Malignant Neoplasm; Advocacy; Advocate; Africa South of the Sahara; Cancer Advocacy; Cancer Control; Cancer Etiology; Caring; Cervical Cancer Screening; Cessation of life; Characteristics; Client; Clinic; Clinical; Collaborations; Country; Data; Development; Diffusion; Effectiveness; Enrollment; Ensure; Equipment; Evaluation; Exploration, Preparation, Implementation, and Sustainment; Exposure to; Family; Fright; Funding; Government; Human Papilloma Virus-Related Malignant Neoplasm; Hybrids; Incidence; Income; Intervention; Interview; Knowledge; Lesion; Maintenance; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Mediator; Methods; Motivation; Network-based; Participant; Patients; Periodicals; Phase; Positioning Attribute; Preparation; Prevalence; Privatization; Provider; Public Health; Radiation therapy; Ramp; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Reporting; Research Design; Rural; Site; Social Network; Structure; Supervision; Telephone; Testing; Time; Touch sensation; Training; Uganda; Visual; Waiting Lists; Woman; advanced disease; cancer risk; cervical cancer prevention; comparison control; cost; cost-effectiveness evaluation; effectiveness/implementation trial; empowerment; evidence base; fighting; follow-up; group intervention; implementation framework; implementation outcomes; implementation science; implementation strategy; indexing; innovation; intervention effect; low and middle-income countries; medically necessary care; member; multidisciplinary; operation; peer; peer support; premalignant; prevent; provider-level barriers; recruit; remediation; response; rural area; screening; screening services; social influence; social stigma; theories; therapy design; treatment as usual; uptake; urban area; virtual

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.

项目概要 宫颈癌 (CC) 是乌干达女性癌症相关死亡的主要原因，该国有一个 醋酸 (VIA) CC 筛查的循证目视检查是世界上发病率最高的国家之一。 免费或低成本，但约 5% 的乌干达女性曾经做过 CC 筛查，约 80% 患有晚期癌症 当开始护理时，利用网络扩散和社会影响的理论以及已知的患者水平， CC 筛查的非结构性障碍和促进因素，我们建立了同行主导的 7 次会议小组 宫颈癌预防的干预游戏规则改变者 (GC-CCP)，患者层面的实施 增加 CC 筛查的策略使最近接受过 CC 筛查的女性能够 通过传播 CC 知识、消除神话，鼓励在社交网络中对女性进行筛查， 一项 R21 资助的试点随机对照试验 (RCT) 揭示了 CC 的显着效果。 增加以前未筛选的社交网络成员中的 CC 筛选（即更改这些结果）。 以及我们的多学科团队成功合作的良好记录，使该应用程序能够 对乌干达的 CC 预防和控制产生了重大影响，这可以推广到其他低至 我们提出了 GC-CCP 的混合 1 型 RCT 来评估其有效性。 增加基于证据的 VIA 筛查、实施和可持续性研究设计的采用。 以探索、准备、实施和维持 (EPIS) 实施科学为指导 探索：本阶段开始完成试点和研究地点选择（两个公共、两个）。 私人，城市和农村各一个）准备工作：在第一年，我们将确定并修复诊所 - 以及提供者层面的障碍，以确保获得和提供 CC 筛查服务的良好实施：在。 每个中心将有 40 名接受 CC 筛查的女性作为索引参与者（n = 160 索引）参加 RCT，并 随机分配到干预或候补名单对照中，每个指标将招募最多三个（一级）替代者（n~440）。 基线时尚未筛查 CC 的参与者；这些指数和改变的参与者将在 第 6 个月和第 12 个月。在第 6 个月，这些分身将分别招募最多两名（二级）分身（n ~800 名分身）进行一次 电话访谈：入组指标接受干预后，各诊所将进行电话访谈。 继续实施 GC-CCP（未参加 RCT 的客户）另外 2.5 年，并接受培训 和监督任务转移给诊所工作人员，我们将使用 RE-AIM 框架评估参与度。 GC-CCP 和 CC 倡导（覆盖范围）、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）以及创新性、可持续性。 GC-CCP 等实施策略对于增加 CC 筛查的需求至关重要。