Reduce Transmission Risks & Improve HCV Treatment Access

描述(由申请人提供)：本研究的目的是确定 降低高风险的行为干预的有效性 丙型肝炎病毒感染青少年的传播行为 注射吸毒者(注射吸毒者)，并确定将被 有资格并愿意接受治疗以根除丙型肝炎病毒感染。自.以来 95%的注射吸毒者丙型肝炎病毒血清阳性，未经治疗，并有能力 传播感染，存在一个非常大的丙型肝炎病毒感染宿主。丙型肝炎病毒 通常是新吸毒者中第一个通过血液传播的感染；因此， 丙型肝炎病毒预防战略与艾滋病毒预防相关。在一个单独的 通过资助对年轻和新的注射器进行现场研究，我们开发了一种 基于同龄人的丙型肝炎病毒教育干预，正在进行一项研究，以 评估其在减少可能导致丙型肝炎和艾滋病毒的行为方面的有效性 丙型肝炎病毒阴性的年轻注射吸毒者中的感染。我们建议测试一下这种能力 根据相同的行为理论进行干预以减少危险行为 在年轻的丙型肝炎病毒血清阳性注射吸毒者中。我们的具体目标是：1)确定 “同龄人志愿者激进主义”干预的有效性 750名感染丙型肝炎病毒的年轻注射吸毒者的高危传播行为 在美国三个城市，当与注意力控制条件相比时，3，6和 干预后12个月；2)测量丙型肝炎病毒感染比例 根据四个广泛的标准有资格接受丙型肝炎病毒治疗的血清阳性注射吸毒者 标准：i)活动性感染或肝病的证据，如 血清丙氨酸氨基转移酶水平和丙型肝炎病毒核糖核酸，ii)可能存在的疾病 是治疗的禁忌，包括抑郁症和饮酒，三) 通过持续使用不安全的注射药物而有可能再次感染，以及 四)完成体检检查，作为准备就绪的一项指标 丙型肝炎病毒治疗；3)开发和验证一种工具来识别个人 他们表现出愿意接受丙型肝炎病毒治疗。为了实现这些目标，我们将 招募、筛选并随机分配750名年轻的丙型肝炎病毒抗体阳性注射吸毒者 在巴尔的摩、纽约和西雅图进行行为干预，以及 前瞻性地对参与者进行季度监测，为期12个月。主要结果是 目标1是减少分布式共用针头；次要成果包括 酗酒、共用其他注射用具、艾滋病毒感染以及 增加避孕套的使用。通过目标2，我们将比较注射吸毒者的比例 符合当前和新的丙型肝炎治疗共识指南，对其进行修订 计划于2002年举行。通过AIM 3，我们将开发一个评估丙型肝炎病毒的工具 治疗准备情况，为临床决策提供广泛的应用。通过 解决行为和临床研究问题，这个项目将 在这种高风险中帮助减轻丙型肝炎病毒和艾滋病毒感染的负担 并将为政策决定提供信息，包括经修订的 丙型肝炎病毒治疗的临床指南。

DESCRIPTION (provided by applicant): The purpose of this study is to determine the efficacy of a behavioral intervention to reduce high‑risk transmission behaviors among hepatitis C virus (HCV)‑infected young injection drug users (IDUs), and to identify the proportion that would be eligible and willing to undergo treatment to eradicate HCV infection. Since 65‑95% of IDUs are HCV seropositive, untreated, and capable of transmitting infection, a very large reservoir of HCV infection exists. HCV is often the first blood borne infection to be acquired among new IDUs; therefore, HCV prevention strategies are relevant to HIV prevention. Under a separately funded multi‑site study of young and new injectors, we have developed a peer‑based HCV education intervention and are engaged in a study to evaluate its efficacy in reducing behaviors that may lead to HCV and HIV infection among HCV‑negative young IDUs. We propose to test the ability of an intervention based on the same behavioral theory to reduce risk behaviors among young HCV‑seropositive IDUs. Our specific aims are: 1) To determine the efficacy of a "peer‑volunteer activism" intervention to reduce high‑risk transmission behaviors among 750 HCV‑infected young IDUs in three US cities, when compared to an attention control condition at 3, 6 and 12‑month post-intervention; 2) To measure the proportion of HCV seropositive IDUs who are eligible for HCV therapy according to four broad criteria: i) evidence of active infection or liver disease, as indicated by serum ALT levels and HCV‑RNA, ii) pre‑existing conditions that may be contraindications for treatment, including depression and alcohol use, iii) potential for re‑infection via continued unsafe injection drug use, and iv) completion of medical screening visits, as an indicator of readiness for HCV therapy; 3) To develop and validate an instrument to identify individuals who demonstrate a readiness to undergo HCV therapy. To meet these aims, we will recruit, screen, and randomly assign 750 young HCV‑antibody positive IDUs in Baltimore, New York and Seattle to a behavioral intervention, and prospectively monitor participants quarterly for 12 months. The primary outcome for Aim 1 is to reduce distributive needle sharing; secondary outcomes include alcohol use, sharing of other injection paraphernalia, HIV infection, and increase condom use. Through Aim 2, we will compare the proportion of IDUs who meet current and new consensus guidelines for HCV therapy, revisions for which are scheduled for 2002. Through Aim 3, we will develop a tool to assess HCV treatment readiness with broad applications for clinical decision-making. By addressing both behavioral and clinical research questions, this project will help lessen the burden of HCV and HIV infection in this high‑risk population and will serve to inform policy decisions, including revised clinical guidelines for HCV treatment.