Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection

描述（由申请人提供）：迫切需要采取干预措施，以增加HIV/HCV合并感染者对丙型肝炎病毒（HCV）治疗的接受率。终末期肝病现在是HIV阳性者死亡的主要原因，主要是由于未经治疗的慢性HCV感染，尽管HCV治疗的有效性取得了显着进展，但HCV治疗的接受率仍然很低。本研究将制定一项干预措施，解决患者层面的障碍（信息，动机和行为技能），以HCV治疗吸收艾滋病毒合并感染的患者，并测试其可行性，可接受性和可持续性的有效性。在形成性研究的基础上，我们开发了“丙型肝炎治疗的心理社会准备评估和准备（PREP-C）”。PREP-C是一个结构化的基于网络的访谈，提供了一个客户的心理准备开始丙型肝炎病毒治疗的评估，并确定需要干预，以提高治疗准备的功能域。PREP-C已在近100名患者中进行了试点，并于2012年启动了针对保健提供者的远程医疗资源（www.prepC.org）。在这项研究中，我们将开发和测试一种综合评估行为干预，以增加HIV合并感染患者的HCV治疗开始。我们的具体目标是：（1）正式调整现有的基于PREP-C评估的行为医学干预措施，以针对在医学上符合HCV治疗条件的HIV/HCV合并感染患者中启动HCV治疗的个体障碍（信息、动机和行为技能），在15名HIV/HCV合并感染患者中进行试点测试和改进定制干预，并最终确定干预手册。(2)对60例在医学上符合HCV治疗条件的HIV/HCV合并感染患者进行一项初步随机临床试验，比较护士提供的PREP-C干预（n=30）与注意力控制（n = 30），以评价患者接受度、患者满意度、入组和保留率，以及初步疗效（在随机化后6个月内开始HCV治疗，并且在开始治疗的患者中持续并坚持治疗的前12周）。我们假设，PREP-C干预将增加动机，信息和自我效能，导致更高的率HCV治疗的启动，持续性和依从性在PREP-C干预arm. Findings从这个先锋研究将通知设计参数的一个更大的，更严格的评估在R 01应用程序，如果结果是有希望的。PREP-C网络评估和干预一揽子计划的设计是可扩展的，可通过PrepC.org网站传播。拟议的研究是创新的，因为它旨在为卫生保健提供者开发第一个基于网络的干预措施，以增加HIV/HCV合并感染者的HCV治疗开始。该研究可以通过为卫生保健提供者提供所需的结构化资源来提高HIV/HCV合并感染者的HCV治疗启动率，从而降低终末期肝病的死亡率，从而产生重大的公共卫生影响。

DESCRIPTION (provided by applicant): There is an urgent need for interventions to increase hepatitis C virus (HCV) treatment uptake among HIV/HCV-co-infected persons. End-stage liver disease is now a leading cause of death among HIV-positive persons, largely due to untreated chronic HCV infection, and rates of HCV treatment uptake remain low despite significant advances in the effectiveness of HCV treatment. This study will develop an intervention addressing patient-level barriers (Information, Motivation, and Behavioral Skills) to HCV treatment uptake in HIV-co-infected patients and test its feasibility, acceptability, and preliminay efficacy. Based on formative research, we have developed the "Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C)". PREP-C is a structured web-based interview that provides an assessment of a client's psychosocial readiness to begin HCV treatment and identifies domains of functioning which require intervention to improve treatment readiness. PREP-C has been piloted in almost 100 patients and a telemedicine resource for health care providers was launched in 2012 (www.prepC.org). In this study, we will develop and test an integrated assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected patients. Our specific aims are: (1) To formally adapt existing behavioral medicine interventions based on PREP-C assessment to target individual barriers (Information, Motivation, and Behavior Skills) to HCV treatment initiation in HIV/HCV-co-infected patients who are medically eligible for HCV treatment, pilot test and refine the tailored intervention in 15 HIV/HCV-co-infected patients, and finalize the intervention manual. (2) To conduct a pilot randomized clinical trial with 60 HIV/HCV-co-infected patients who are medically eligible for HCV treatment, comparing the nurse-delivered PREP-C intervention (n=30) with attention control (n=30) in order to evaluate patient acceptance, patient satisfaction, enrollment and retention, as well as preliminary efficacy (initiation of HCV treatment within 6 months of randomization and persistence and adherence to the first 12 weeks of treatment in those who do initiate treatment). We hypothesize that the PREP-C intervention will increase Motivation, Information, and Self-Efficacy leading to higher rates of HCV treatment initiation, persistence and adherence in the PREP-C intervention arm. Findings from this vanguard study will inform the design parameters of a larger, more rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based assessment and intervention package is designed to be scalable and can be disseminated through the live PrepC.org web site. The proposed study is innovative in that it seeks to develop the first web-based intervention for health care providers t use to increase HCV treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health impact by providing needed structured resources for health care providers to increase rates of HCV treatment initiation in HIV/HCV-co- infected persons, thereby reducing mortality due to end-stage liver disease.