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: 8142894
• 负责人: Michael Scott Gordon
• 金额: $ 73.16万
• 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/8142894
• 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; Healthcare; Heroin Dependence; High Prevalence; Highly Active Antiretroviral Therapy; Human immunodeficiency virus test; Imprisonment; Improve Access; Individual; Infection; Informed Consent; Injection of therapeutic agent; 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; 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. PUBLIC HEALTH RELEVANCE: The present proposal is of great significance because of the over 5 million individuals on parole and probation in the US and their disproportionate involvement in drug use and other HIV risk behavior compared to the general population. Furthermore, there are many potential barriers to receiving care in the community that exist for such a marginalized and stigmatized population. The study is highly innovative as we are not aware of reports of attempts to integrate HIV testing and linkage to care in this large at-risk population. Finally, this application is of high public health relevance because of the need to greatly improve access to testing and treatment for at-risk populations to stem the tide of HIV infection in the United States.

描述（由申请人提供）：大量证据表明，刑事司法人口因注射吸毒和无保护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很大程度上被社区矫正所忽视（即，缓刑和假释）人口。尽管刑事司法参与和艾滋病毒的风险行为和感染之间的联系，很少有人知道艾滋病毒的风险行为和感染的流行率在假释或缓刑的个人。我们建议在社区矫正中进行HIV检测的随机试验，以及通过社区矫正（缓刑和假释）招募的HIV感染者与HIV护理联系的单臂干预（队列）研究。第一项研究是两组随机对照试验，其中马里兰州的巴尔的摩市和罗得岛的普罗维登斯的6，000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）由出于本研究目的而在缓刑/假释办公室共处的研究人员进行的现场快速测试;或2）在社区卫生中心或HIV检测诊所进行快速HIV检测的非现场转诊。对于队列研究，所有在社区矫正中被确定为艾滋病毒感染者的个人将被纳入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罗德岛州普罗维登斯这两个城市的理由是，海洛因成瘾率历来很高，这与多种艾滋病毒相关的风险行为有关，而且缓刑和/或假释的可能性很高。随机试验的结局将包括：a）接受HIV检测;和B）收到HIV检测结果。队列研究的结果将包括：a）与其HIV提供者下次（或首次）预约的时间; B）HIV护理的保留; c）对于那些处方此类药物的阳性患者开始HAART药物治疗;以及d）对于那些处方HAART的患者，在12个月内达到不可检测的HIV血浆病毒载量的个体比例。 公共卫生相关性：目前的提案具有重要意义，因为美国有500多万假释和缓刑人员，与普通人群相比，他们不成比例地参与吸毒和其他艾滋病毒风险行为。此外，对于这样一个被边缘化和被污名化的群体来说，在社区接受护理方面存在着许多潜在的障碍。这项研究具有高度的创新性，因为我们不知道有报道说，在这一庞大的高危人群中，有人试图将艾滋病毒检测和护理联系起来。最后，这一应用具有高度的公共卫生相关性，因为需要大大改善高危人群获得检测和治疗的机会，以遏制美国艾滋病毒感染的浪潮。