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

HIV 检测及其与护理的联系的随机对照试验和队列研究

• 批准号: 8490329
• 负责人: Michael Scott Gordon
• 金额: $ 65.47万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8490329
• 关键词: AIDS prevention; Adopted; Adult; Appointment; Baltimore; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Cities; Clinic; Cohort Studies; Communities; Community Health Centers; Criminal Justice; Drug usage; Enrollment; Exclusion Criteria; Female; General Population; HIV; HIV Infections; HIV Seropositivity; HIV risk; Healthcare; Heroin Dependence; High Prevalence; Highly Active Antiretroviral Therapy; Human immunodeficiency virus test; Imprisonment; Improve Access; Individual; Infection; Informed Consent; Intervention; Intervention Studies; Jail; Link; Location; Maryland; Minority; Newly Diagnosed; Outcome; Pharmaceutical Preparations; Plasma; Population; Populations at Risk; Prevalence; Prisoner; Prisons; Provider; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Research; Rhode Island; Risk; Risk Behaviors; Site; Test Result; Testing; Time; United States; Unsafe Sex; Viral Load result; Woman; arm; base; cohort; design; high risk; improved; inclusion criteria; injection drug use; innovation; male; parole; parolee; probation; probationer; public health relevance; randomized trial; stem; theories; willingness

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.

说明(申请人提供)：大量证据表明，刑事司法人员因注射毒品和无保护的性行为感染艾滋病毒的风险高得不成比例。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危险行为和感染之间的联系已得到证实，但人们对假释或缓刑个人中艾滋病毒危险行为和感染的流行率知之甚少。我们建议对社区矫正中的艾滋病毒检测进行随机试验，并对通过社区矫正(缓刑和假释)招募的艾滋病毒携带者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，马里兰州巴尔的摩市和罗德岛州普罗维登斯市的6000名男性和女性缓刑犯和假释者将被随机分配到以下两种治疗条件之一：1)由为本研究目的在缓刑/假释办公室共同办公的研究人员进行现场快速检测；或2)在社区卫生中心或艾滋病毒检测诊所进行非现场转介进行快速艾滋病毒检测。在队列研究中，所有在社区惩教中被确认为艾滋病毒携带者的人将被提供参加一项为期一年的干预研究，该研究使用Project Bridge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和里约热内卢普罗维登斯这两个城市的理由是，海洛因成瘾率处于历史高位，与多种与艾滋病毒相关的危险行为有关，而且缓刑和/或假释的可能性很高。随机试验的结果将包括：a)接受艾滋病毒检测；以及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)与艾滋病毒提供者预约的时间；b)保留艾滋病毒护理；c)为那些阳性的患者开始服用HAART药物；以及d)那些接受HAART治疗的患者，在12个月内达到无法检测到的艾滋病毒血浆病毒载量的个人比例。