HBV Prevention for Homeless At-Risk for HBV/HCV/HIV

描述(申请人提供)：在全国范围内，由于过度使用注射毒品、无保护的性行为、卖淫和受害，无家可归者面临感染艾滋病毒的风险。在无家可归的成年人中，乙肝病毒和丙型肝炎病毒的感染率很高，因为他们与艾滋病毒具有共同的危险因素。甲型肝炎病毒(HAV)在易受乙肝病毒、丙型肝炎病毒和艾滋病毒感染的人群中也很高，因为甲型肝炎病毒的传播方式与乙肝病毒、丙型肝炎病毒和艾滋病毒的传播方式重叠。因此，针对甲型肝炎、乙肝病毒、丙型肝炎病毒和乙肝病毒的教育和筛查计划，与甲型肝炎和乙肝疫苗接种计划相结合，可以显著降低肝炎相关的发病率和死亡率。然而，无家可归者--其中许多人可能正在与吸毒、酗酒和失业作斗争，生活在一个混乱的世界中，几乎没有机会获得保健和社会服务--往往是不遵守规定的。在这项前瞻性的两组准实验设计中，我们将对洛杉矶贫民区约1000名有庇护的男性和女性进行评估，评估以理论为基础的甲肝/乙肝疫苗干预措施的有效性，主要集中在完成Twinrix甲肝/乙肝联合疫苗系列，其次是降低甲型肝炎、乙肝病毒、丙型肝炎和艾滋病毒的风险。我们还将收集每个项目在完成甲型肝炎/乙肝疫苗接种方面的相对成本、提高疫苗接种完成率的成本效益、每个血清保护病例的成本和预防每个感染的成本的数据。一旦确定符合条件，参与者将通过庇护所随机进入两个计划之一：护士病例管理加激励和跟踪(NCMIT)计划和标准加激励和跟踪(SIT)计划。这项拟议的研究是创新的，因为SIT和NCMIT计划的比较将使我们能够看到结合简短教育、激励和跟踪的标准干预的效果，以及类似干预的效果，类似干预还包括完成HAV/HBV疫苗接种后的护士病例管理。这两个计划的参与者将在研究诊所接受由训练有素的研究护士在六个月内进行的3系列疫苗接种，同时接受NCMIT或SIT计划。所有参与者将在基线以及6个月和12个月的随访中使用一系列心理社会、行为、健康和身体状况以及甲型肝炎病毒、乙肝病毒、丙型肝炎病毒和艾滋病毒血清状态测量进行评估。这项拟议的研究支持国家药物滥用研究倡议，因为它侧重于评估促进在无家可归和药物滥用人群中预防HAB、乙肝病毒、丙型肝炎和艾滋病毒的医疗后果的干预计划的有效性。

DESCRIPTION (provided by applicant): Nationwide, homeless populations are at risk for HIV infection due to disproportionate use of injection drugs, unprotected sexual activity, prostitution and victimization. Infection with the Hepatitis B Virus (HBV) and the Hepatitis C Virus (HCV) is high among homeless adults as they share risk factors with HIV. Hepatitis A Virus (HAV) is also high among populations vulnerable to HBV, HCV, and HIV as modes of transmission for HAV overlap with those of HBV, HCV, and HIV. Thus, education and screening programs for HAV, HBV, HCV, and HW, combined with vaccination programs for HAV and HBV, can significantly decrease Hepatitis-related morbidity and mortality. However, homeless persons, many of whom may be contending with drug and alcohol abuse and unemployment, and live in a disorganized world with little access to health and social services, are often non-compliant. In this prospective two group quasi-experimental design, we will evaluate with approximately 1000 sheltered men and women in the Skid Row area of Los Angeles, the effectiveness of a theoretically-based HAV/HBV vaccination intervention focused primarily on completion of the combined Twinrix HAV/HBV vaccination series and secondarily on risk reduction of HAV, HBV, HCV, and HIV. We will also collect data on the relative cost of each of these programs in terms of completion of HAV/HBV vaccination, the cost effectiveness of improving vaccination completion, the cost per sero-protected case, and the cost per infection prevented. Once determined eligible, participants will be randomized by shelter into one of two programs: a Nurse Case Managed Plus Incentive and Tracking (NCMIT) program and a Standard Plus Incentive and Tracking (SIT) program. The proposed study is innovative in that the comparison of the SIT and NCMIT programs will allow us to look at the effect of a standard intervention combining brief education, incentives and tracking with that of a similar intervention that also includes nurse case management on completion of the HAV/HBV vaccination. Participants in the two programs will receive the 3-series vaccination by trained research nurses at the study clinic over six months, along with either the NCMIT, or the SIT program. All participants will be assessed at baseline and six- and twelve-month follow-up using a battery of psychosocial, behavioral, health and physical status, as well as HAV, HBV, HCV, and HIV sero-status measurements. This proposed study supports the National Drug Abuse Research Initiative as it is focused on assessing the effectiveness of intervention programs promoting the prevention of medical consequences of HAB, HBV, HCV, and HIV in homeless and drug abusing populations.