Adaptation and testing of a primary care HCV group medical treatment intervention

 描述（由申请人提供）：Brianna Norton，DO，MPH是一名经过传染病培训的医生，研究员，在社区联邦合格健康中心（CIMHC）照顾患者，并进行研究以改善HCV和HIV/HCV感染的注射吸毒者（IDUs）的健康结果。虽然注射吸毒者占美国所有HCV+和HIV/HCV+患者的绝大多数，但我们目前的医疗保健提供系统未能使这些患者参与HCV护理，如果不立即采取行动，HCV相关死亡人数将在未来十年增加两倍。新的HCV药物的治愈率高达100%，副作用很少，但沿着HCV级联护理的差距阻止注射吸毒者开始治疗。迫切需要基于注射吸毒者已经获得的初级保健环境的创新医疗保健提供干预措施，以改善挽救生命的HCV药物的使用。团体医疗访问可以利用有益的同伴动力，为积极的健康行为提供支持和动力，并通过团体教育和培训提高知识和自我效能技能。该职业发展应用程序的总体目标是测试基于初级保健诊所的HCV组评估和治疗摄取（HCV GET-UP）干预HCV+和HIV/HCV+注射吸毒者。该提案的具体目标是：1）进行HCV GET-UP的可行性和可接受性研究; 2）在试点RCT中测试HCV GET-UP干预措施对改善HCV+和HIV/HCV+ IDUs中HCV治疗吸收的有效性; 3）进行定量和定性分析，以确定HCV GET-UP干预措施对HCV治疗吸收的潜在调节剂和介导剂。为了实现目标1，我们将对两个HCV GET-UP组（共16名受试者）进行可行性和可接受性研究。根据这些发现，我们将完善干预措施，并创建一个HCV GET-UP干预手册。我们预计，集体医疗访问将包括HCV临床评估，教育，同行和供应商的支持，以及自我管理技能的发展。为了测试HCV GET-UP（目标2）的疗效，我们将入组96名HCV+和HIV/HCV+ IDUs，并将其以1：1的比例随机分配至HCV GET-UP组和单独现场治疗组。主要结局将是HCV治疗的开始;次要结局将包括HCV评估、治疗完成和治愈。最后，采用序贯解释性设计，我们将确定HCV GET-UP干预对HCV治疗摄取的潜在调节因子和介导因子。这些发现将有助于改善未来R 01的干预设计，以及提高我们对注射吸毒者接受HCV治疗的现有障碍和促进因素的理解。诺顿博士将接受多学科专家团队的指导。诺顿博士的培训目标是培养以下方面的技能：1）行为干预的开发和测试; 2）随机对照试验的设计和实施; 3）复杂数据的统计分析; 4）定性方法。拟议项目的完成将为诺顿博士作为一名独立调查员的职业生涯奠定基础，致力于改善HCV和HIV/HCV+注射吸毒者的健康结果。

 DESCRIPTION (provided by applicant): Brianna Norton, DO, MPH is an infectious diseases trained physician-investigator who cares for patients in a community-based Federally Qualified Health Center (FQHC) and conducts research to improve health outcomes among HCV- and HIV/HCV-infected injection drug users (IDUs). Though IDUs comprise the overwhelming majority of all HCV+ and HIV/HCV+ persons in the U.S, our current health care delivery system has failed to engage such patients in HCV care, and without imminent action, HCV-related deaths will triple over the next decade. New HCV medications have cure rates as high as 100% and few side effects, but gaps along the HCV cascade of care prevent IDUs from ever initiating treatment. Innovative health care delivery interventions, based in primary care settings that IDUs are already accessing, are urgently needed to improve uptake of life-saving HCV medications. Group medical visits can harness beneficial peer dynamics to provide support and motivation for positive health behaviors, and improve knowledge and self-efficacy skills through group education and training. The overall goal of this career development application is to test a primary care clinic-based HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention for HCV+ and HIV/HCV+ IDUs. The proposal's specific aims are: 1) to conduct a feasibility and acceptability study of HCV GET-UP; 2) to test, in a pilot RCT, the efficacy of the HCV GET-UP intervention for improving HCV treatment uptake among HCV+ and HIV/HCV+ IDUs; and 3) to conduct quantitative and qualitative analyses in order to determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. To achieve Aim 1, we will conduct a feasibility and acceptability study of two HCV GET-UP groups (total of 16 participants). Based on these findings, we will refine the intervention and create an HCV GET-UP intervention manual. We anticipate that group medical visits will include HCV clinical assessments, education, peer and provider support, and self-management skill development. To test the efficacy of HCV GET-UP (Aim 2), we will enroll 96 HCV+ and HIV/HCV+ IDUs and randomize them 1:1 to HCV GET-UP vs. onsite treatment alone. The primary outcome will be initiation of HCV treatment; secondary outcomes will include HCV evaluation, treatment completion, and cure. Finally, using a sequential explanatory design, we will determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. These findings will help to improve the intervention design for a future R01, as well as enhance our understanding of current barriers and facilitators to HCV treatment uptake for IDUs. Dr. Norton will receive mentorship from a multidisciplinary team of experts. Dr. Norton's training goal is to develop skills in: 1) development and testing of behavioral interventions; 2) design and conduct of randomized controlled trials, 3) statistical analysis of complex data; and 4) qualitative methods. Completion of the proposed project will provide the foundation for Dr. Norton's career as an independent investigator dedicated to improving health outcomes for HCV and HIV/HCV+ IDUs.