A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care

描述（由申请人提供）：大量证据表明，刑事司法人口因注射毒品和无保护的性行为而感染艾滋病毒的风险过高。艾滋病毒检测和预防在社区矫正（即缓刑和假释）人群中基本上被忽视。尽管刑事司法参与与艾滋病毒风险行为和感染之间存在明显联系，但人们对假释或缓刑人员中艾滋病毒风险行为和感染的流行程度知之甚少。我们建议在社区矫正中进行艾滋病毒检测的随机试验，并对通过社区矫正招募的艾滋病毒感染者（缓刑和假释）进行与艾滋病毒护理联系的单臂干预（队列）研究。第一项研究是一项两组随机对照试验，其中来自马里兰州巴尔的摩市和罗德岛州普罗维登斯的6000名男性和女性缓刑犯和假释犯将被随机分配到两种治疗条件之一：1)由缓刑/假释办公室的研究人员进行现场快速测试；或2)转介到社区卫生中心或HIV检测诊所进行快速HIV检测。在队列研究中，所有在社区矫正所发现的艾滋病毒感染者都将被纳入一项为期一年的干预研究，该研究使用“桥梁项目”来帮助改善与艾滋病毒护理的联系。选择马里兰州巴尔的摩市和罗德岛普罗维登斯这两个城市的理由是，历史上海洛因成瘾率很高，这与多种与艾滋病毒相关的风险行为有关，而且很有可能被缓刑和/或假释。随机试验的结果将包括：a)接受艾滋病毒检测；b)收到艾滋病毒检测结果。队列研究的结果将包括：a)下一次（或第一次）与HIV提供者预约的时间；b)继续接受艾滋病毒护理；c)对已开了HAART药物的阳性患者开始接受这种药物治疗；d)接受HAART治疗后12个月内血浆病毒载量检测不到的个体比例。

DESCRIPTION (provided by applicant): Substantial evidence indicates that criminal justice populations are at disproportionately high risk for HIV infection from both injection drug use and unprotected sex. HIV testing and prevention have largely been ignored among community correction (i.e., probation and parole) populations. Despite the demonstrated link between criminal justice involvement and HIV risk behaviors and infection, little is known about the prevalence of HIV risk behaviors and infection among individuals on parole or probation. We propose to conduct both a randomized trial of HIV testing in community corrections, and a single arm intervention (cohort) study of linkage to HIV care for people with HIV recruited through community corrections (probation and parole). The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned either to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. For the cohort study, all individuals identified at community corrections with HIV will be offered enrollment in a one year intervention study using Project Bridge to help improve linkage into HIV care. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction which is associated with multiple HIV-related risk behaviors and a high likelihood of being on probation and/or parole. Outcomes for the randomized trial will include: a) undergoing HIV testing; and b) receipt of HIV testing results. Outcomes for the cohort study will include: a) time to next (or first) appointment with their HIV provider; b) retention in HIV care, c) initiation of HAART medications for those positive for whom such medications are prescribed; and d) proportion of individuals achieving undetectable HIV plasma viral load over 12 months for those prescribed HAART.