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

项目摘要 携带艾滋病毒的男男性行为者(MSM)患肛门癌的风险是男性感染者的80倍 普通人群，使男男性接触者成为实施循证肛门癌症预防的关键人群 干预措施。在美国21个临床地点对艾滋病毒携带者进行的随机对照试验， 新近建立的高度鳞状上皮内病变(HSIL)治疗的循证研究 用于肛门癌预防的干预(EBI)。鉴于其既定的疗效，HSIL的筛查和治疗 在低收入和中等收入国家(LMIC)应作为预防肛门癌的预防性护理来实施 艾滋病毒高度流行的环境。为了加速在LMIC环境中采用HSIL筛查和治疗， 我们将利用现有的艾滋病毒基础设施，信托诊所，尼日利亚的男男性接触者友好设施，有 自2012年以来一直为一群男男性接触者提供艾滋病毒护理。我们进行了一项概念验证肛门癌筛查。 在TRUST诊所进行的研究和治疗，发现MSM社区的吸毒率很高；代表性，如 被筛查的人的艾滋病毒和高危人乳头瘤病毒的流行率与我们的总体队列相似；以及 患者总体满意度。尽管筛查量很高，但我们没有发现和治疗HSIL。 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 这是阻碍EBI忠实实施的主要障碍。拟议的综合方案的目标 使用HSIL筛查和治疗预防肛门癌的模型(IMPACT)研究旨在解决这些问题 障碍，同时利用现有信托诊所基础设施中的促进者来创建增强的 HSIL(e-STH)干预的筛查和治疗培训。为了实现这一目标，在目标1中，我们将使用 实施研究综合框架(CFIR)和确定障碍和 辅导员在信托诊所接受EBI的常规培训。在目标2中，我们将聘请一个实施团队来 共同设计e-STH干预措施，将CFIR确定的障碍与 实施变革的专家建议(ERIC)框架。然后我们将进行迭代 基于特定标准测试和细化e-STH干预实施的改进方法 结果。在目标3中，我们将进行前瞻性研究，以评估覆盖范围、有效性和实施情况，并 与使用RE-AIM框架的常规培训相比，探索e-STH的可持续性。建议数 影响研究将深入了解HSIL筛查和治疗EBI的实施情况 在尼日利亚现有的以社区为基础的艾滋病毒诊所，并产生了跨LMIC可伸缩性的基本证据。

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.