Integrated Model for the Prevention of Anal Cancer using screen and Treat for HSIL (IMPACT)

项目摘要 与感染艾滋病毒的男男性行为者 (MSM) 相比，感染艾滋病毒的男性患肛门癌的风险高出 80 倍 普通人群，使 MSM 成为实施循证肛门癌预防的关键人群 干预措施。在美国 21 个临床中心针对 HIV 感染者进行的一项随机对照试验， 最近建立的治疗高度鳞状上皮内病变（HSIL）的循证疗法 预防肛门癌的干预措施（EBI）。鉴于其既定疗效，HSIL 筛查和治疗 应作为预防性护理来实施，以预防低收入和中等收入国家 (LMIC) 的肛门癌 HIV 高度流行的环境。为了加速在 LMIC 环境中采用 HSIL 筛查和治疗， 我们将利用现有的 HIV 基础设施，即 TRUST 诊所，这是尼日利亚的一个对 MSM 友好的设施， 自 2012 年以来一直为一群 MSM 提供艾滋病毒护理。我们进行了概念验证性肛门癌筛查 TRUST 诊所的治疗研究，发现 MSM 社区的接受率很高；代表性，如 被筛查者的艾滋病毒和高危人乳头瘤病毒患病率与我们的整体队列相似；和 患者总体满意度。尽管筛查量很大，但我们对 HSIL 的检测和治疗仍然不足。 确定了护理团队和参与者在 HSIL 筛查和治疗方面的知识差距 是阻碍 EBI 忠实实施的主要障碍。拟议综合的目标 使用 HSIL 筛查和治疗 (IMPACT) 研究预防肛门癌的模型旨在解决这些问题 消除障碍，同时利用现有 TRUST 诊所基础设施内的促进者来创建增强型 HSIL 筛查和治疗 (e-STH) 干预培训。为了实现这个目标，在 AIM 1 中，我们将使用 实施研究综合框架（CFIR）和混合方法来识别障碍和 TRUST 诊所 EBI 常规培训的协调员。在 AIM 2 中，我们将聘请一个实施团队来 通过将 CFIR 识别的障碍与具体策略相匹配，共同设计 e-STH 干预措施 实施变革的专家建议 (ERIC) 框架。然后我们将进行迭代 根据具体情况测试和完善 e-STH 干预实施的改进方法 结果。在 AIM 3 中，我们将进行一项前瞻性研究，以评估其范围、功效和实施情况以及 与使用 RE-AIM 框架的常规培训相比，探索 e-STH 的可持续性。拟议的 IMPACT 研究将深入了解 HSIL 筛查和治疗 EBI 的实施情况 尼日利亚现有的社区艾滋病毒诊所，并为中低收入国家的可扩展性提供重要证据。

Project Abstract Anal cancer risk is 80-fold higher among men who have sex with men (MSM) living with HIV compared to the general population, making MSM a critical population for implementing evidence-based anal cancer prevention interventions. A randomized controlled trial at 21 clinical sites in the United States of people living with HIV, recently established treatment of high-grade squamous intraepithelial lesions (HSIL) as an evidence-based intervention (EBI) for anal cancer prevention. Given its established efficacy, HSIL screening and treatment should be implemented as prophylactic care to prevent anal cancer in low- and middle-income country (LMIC) settings where HIV is highly prevalent. To accelerate adoption of HSIL screening and treatment in LMIC settings, we will leverage an existing HIV infrastructure, the TRUST clinic, an MSM-friendly facility in Nigeria that has been providing HIV care to a cohort of MSM since 2012. We conducted a proof-of-concept anal cancer screening and treatment study at the TRUST clinic and found high uptake in the MSM community; representativeness, as those screened had similar prevalence of HIV and high-risk human papillomavirus as our overall cohort; and overall patient satisfaction. Despite high screening volumes, we under-detected and under-treated HSIL. Knowledge gaps in HSIL screening and treatment among both the care team and the participants were identified as major barriers that impeded implementation of the EBI with fidelity. The objective of the proposed Integrated Model for the Prevention of Anal Cancer using screen and Treat for HSIL (IMPACT) study is to address these barriers while capitalizing on facilitators within the existing TRUST clinic infrastructure to create an enhanced training on Screening and Treatment of HSIL (e-STH) intervention. To achieve this goal, in AIM 1, we will use the Consolidated Framework for Implementation Research (CFIR) and mixed methods to identify barriers and facilitators to usual training on the EBI at the TRUST clinic. In AIM 2, we will engage an implementation team to co-design the e-STH intervention by matching the barriers identified with CFIR with specific strategies in the Expert Recommendations for Implementing Change (ERIC) framework. We will then take an iterative improvement approach to test and refine the implementation of the e-STH intervention based on specific outcomes. In AIM 3, we will conduct a prospective study to evaluate the reach, efficacy, and implementation and explore the sustainability of e-STH compared to usual training using the RE-AIM framework. The proposed IMPACT study will provide insight into implementation of an HSIL screening and treatment EBI adapted for existing community-based HIV clinics in Nigeria and generate essential evidence for scalability across LMICs.