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.

项目摘要 宫颈癌（CC）是乌干达女性与癌症相关死亡的主要原因，乌干达有一个 世界上最高的事件率。用乙酸（VIA）CC筛选是基于证据的视觉检查 免费或低成本，但约有5％的乌干达妇女曾经筛过CC，约有80％患有晚期癌症 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级别的理论 非结构性障碍和CC筛查的促进者，我们开发了同行为7会议小组 干预游戏改变宫颈癌预防（GC-CCP），这是一种患者级实施 增加CC筛查的策略。 GC-CCP赋予了最近筛选CC的女性 通过传播CC知识，消除神话，鼓励妇女在社交网络中筛查 并减少CC污名。 R21资助的飞行员随机对照试验（RCT）揭示了 增加了以前未经筛选的社交网络成员（即改变）中的CC筛查。这些结果， 以及我们的多学科团队成功合作的良好记录，将此申请定位为 对乌干达的CC预防和控制产生强烈影响，这可能是其他低点的 中收入国家环境。我们提出了GC-CCP 1型混合型RCT，以评估其有效性 通过筛查以及实施和可持续性增加基于证据的吸收。研究设计 以探索，准备，实施和维持（EPIS）实施科学为指导 框架。探索：此阶段由完整的飞行员和研究站点选择（两个公众，两个 私人，每个都在城市和粗糙的位置）。准备：在第一年，我们将确定并补救诊所 以及提供商级别的障碍，以确保良好的CC筛查服务的访问和交付。实施：at 每个站点，有40名女性筛选CC的女性将作为指数参与者（n = 160个指数）注册RCT，并且 随机分配干预或等待名单控制。每个索引最多将招募三个（1级）变化（n〜440 在没有筛选CC的基线时变化）；这些索引和变更参与者将在 第6和第12个月。在第6个月，这些变化将使每个人最多招募两个（2级）的变化（N〜800 Alters） 电话采访。维持：注册指数参与者接受干预后，每个诊所都将 继续实施GC-CCP（不在RCT中注册的客户）额外2。5年，并接受培训 和监督任务转移给诊所工作人员。使用Re-Aim框架，我们将评估参与 GC-CCP和CC倡导（覆盖范围），更改CC筛查（有效性），适应通常的护理， 实施结果（可接受性，忠诚，可行性，成本）和维护。创新，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。