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

 描述(申请人提供)：Brianna Norton，DO，公共卫生硕士，传染病训练有素的医生兼调查员，在以社区为基础的联邦合格卫生中心(FQHC)照顾患者，并进行研究，以改善丙型肝炎病毒和艾滋病毒/丙型肝炎病毒感染的注射吸毒者(IDU)的健康结果。尽管注射吸毒者占美国所有丙型肝炎病毒阳性患者和艾滋病毒/丙型肝炎病毒阳性患者的绝大多数，但我们目前的医疗保健提供系统未能让这些患者参与丙型肝炎病毒的护理，如果不立即采取行动，与丙型肝炎病毒相关的死亡人数将在未来十年增加两倍。新的丙型肝炎病毒药物治愈率高达100%，副作用很少，但丙型肝炎病毒级联治疗过程中的差距阻止了注射吸毒者开始治疗。迫切需要以注射吸毒者已经获得的初级保健环境为基础的创新卫生保健提供干预措施，以改善对挽救生命的丙型肝炎药物的吸收。团体就诊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。这一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丙型肝炎病毒团体评估和治疗摄取(HCV GUP)干预措施，用于丙型肝炎病毒+和艾滋病毒/丙型肝炎+注射吸毒者。该建议的具体目标是：1)对丙型肝炎病毒的组成进行可行性和可接受性研究；2)在试点随机对照试验中测试丙型肝炎病毒增强干预措施对改善丙型肝炎病毒阳性和艾滋病毒/丙型肝炎病毒+注射吸毒者接受丙型肝炎病毒治疗的有效性；以及3)进行定量和定性分析，以确定丙型肝炎病毒增强干预措施对丙型肝炎病毒治疗吸收的潜在调节和调节因素。为了实现目标1，我们将对两个丙型肝炎组织(共16名参与者)进行可行性和可接受性研究。基于这些发现，我们将改进干预措施，并创建一份丙型肝炎病毒起床干预手册。我们预计团体医疗访问将包括丙型肝炎病毒临床评估、教育、同行和提供者支持以及自我管理技能发展。为了测试丙型肝炎病毒补充剂(目标2)的疗效，我们将招募96名丙型肝炎病毒+和艾滋病毒/丙型肝炎病毒+注射用药者，并将他们1：1随机分为丙型肝炎病毒补充剂和单独现场治疗两组。主要结果将是开始丙型肝炎病毒治疗；次要结果将包括丙型肝炎病毒评估、治疗完成和治愈。最后，使用序贯解释性设计，我们将确定在丙型肝炎病毒治疗摄取过程中，丙型肝炎病毒启动干预的潜在调节因子和中介因子。这些发现将有助于改进未来R01的干预设计，并增强我们对注射吸毒者接受丙型肝炎治疗的当前障碍和促进者的理解。诺顿博士将接受一个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)行为干预措施的开发和测试；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，他致力于改善丙型肝炎病毒和艾滋病毒/丙型肝炎病毒+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.