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

使用 HSIL 筛查和治疗预防肛门癌的综合模型 (IMPACT)

• 批准号: 10705313
• 负责人: Sylvia Adebajo
• 金额: $ 72.78万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705313
• 关键词: Acceleration; Address; Adherence; Adoption; Anus; Cancer Control; Cancer Prevention Intervention; Caring; Client; Client satisfaction; Clinic; Communities; Consolidated Framework for Implementation Research; Data; Development; Eligibility Determination; Enrollment; Ensure; Environment; Evidence based intervention; Evidence based treatment; Feasibility Studies; Friends; General Population; Goals; Group Interviews; HIV; HIV risk; HPV-High Risk; Infrastructure; International; Interruption; Intervention; Interview; Knowledge; Language; Learning; Maintenance; Malignant Neoplasms; Malignant neoplasm of anus; Methods; Modeling; Neoplasms; Nigeria; Outcome; Participant; Patients; Persons; Physicians; Policy Maker; Population; Prevalence; Prevention; Prospective Studies; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research; Risk Factors; Screening Result; Screening for cancer; Series; Site; Societies; Squamous intraepithelial lesion; Structure; Testing; Time; Training; United States; Virus; Work; cancer prevention; cancer risk; clinical research site; cohort; cost effective; design; educational atmosphere; evidence base; evidence based guidelines; experience; follow-up; hybrid type 2 trial; implementation barriers; implementation intervention; implementation science; implementation strategy; improved; insight; low and middle-income countries; men who have sex with men; multidisciplinary; prevent; primary outcome; prophylactic; risk mitigation; scale up; screening; screening guidelines; secondary outcome; tool; uptake

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.

项目摘要 与艾滋病毒感染者相比，与艾滋病毒感染者发生性关系的男性（MSM）患肛门癌的风险高出80倍。 一般人群，使MSM成为实施循证肛门癌预防的关键人群 干预措施。一项在美国21个临床地点对艾滋病毒感染者进行的随机对照试验， 最近建立的治疗高度鳞状上皮内病变（HSIL）作为一种循证医学 干预（EBI）预防肛门癌。鉴于其既定的疗效，HSIL筛查和治疗 在低收入和中等收入国家（LMIC）应作为预防肛门癌预防性护理来实施 艾滋病毒高度流行的地方。为了加快在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，即TRUST诊所，这是尼日利亚的一个适合男同性恋者的设施，该设施拥有 自2012年以来一直为一群男男性行为者提供艾滋病毒护理。我们进行了一个概念验证的肛门癌筛查 在TRUST诊所进行的一项治疗研究中发现，MSM群体的吸收率很高;代表性， 接受筛查的人群与我们的整体队列人群的HIV和高危人乳头瘤病毒患病率相似; 患者总体满意度。尽管筛查量很高，但我们对HSIL的检测和治疗不足。 护理团队和参与者在HSIL筛查和治疗方面的知识差距被确定 这是阻碍忠实地实施EBI的主要障碍。拟议综合方案的目标 使用筛查和治疗HSIL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TRUST诊所基础设施内的促进者， HSIL筛查和治疗（e-STH）干预培训。为了实现这一目标，在AIM 1中，我们将使用 实施研究综合框架和确定障碍的混合方法， 协助者在TRUST诊所接受关于EBI的常规培训。在AIM 2中，我们将聘请一个实施团队， 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 改进方法，以测试和完善电子STH干预措施的实施， 结果。在AIM 3中，我们将进行一项前瞻性研究，以评估范围、有效性和实施情况， 探索e-STH与使用RE-AIM框架的常规培训相比的可持续性。拟议 IMPACT研究将提供对HSIL筛查和治疗EBI实施的深入了解， 在尼日利亚现有的基于社区的艾滋病毒诊所中进行评估，并为整个中低收入国家的可扩展性提供必要的证据。