Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments

描述（由申请人提供）：早期识别未确诊的艾滋病毒感染是一项重要的公共卫生优先事项。在美国，尽管采取了若干与艾滋病毒有关的重大公共卫生举措，但仍有约25万名艾滋病毒感染者未得到诊断，每年有5万例新感染。尽管艾滋病毒检测是一项重要的干预措施，但在如何实施方面仍存在争议。2006年，疾病控制和预防中心（CDC）建议在未确诊患病率为0.1%的临床环境中进行非针对性的选择退出艾滋病毒筛查。急诊科（EDs）一直是这些建议的主要焦点，这是因为在美国每年有超过1.2亿人次的急诊科就诊，他们为大部分得不到充分服务的患者提供服务，并且是错过HIV感染诊断机会的最常见场所。相比之下，2007年，美国预防服务工作组建议将有针对性的艾滋病毒筛查（即检测高危亚人群）作为艾滋病毒检测的主要方法，因为没有足够的证据支持疾病预防控制中心的建议。在医学博士、理学硕士Jason Haukoos的带领下，我们的研究团队自2004年以来一直在这一领域开展研究，最近发表了迄今为止规模最大的临床试验，结论是与临床医生的诊断测试（即基于临床体征或症状的测试）相比，ED中非靶向选择退出的快速hiv筛查与新发现的hiv感染患者数量的小幅增加有关。我们的团队最近还开发了丹佛HIV风险评分（DHRS），这是第一个评估HIV感染风险的多变量工具。DHRS结合了3个人口统计学特征和5个行为特征，并根据艾滋病毒感染率的增加将患者分为不同的阶层。在此基础上，我们提出以下具体目标：(1)评估和比较3种现代快速艾滋病毒筛查策略在完全融入常规ED护理时的有效性；(2)衡量和比较各HIV筛查策略的项目成本；(3)衡量和比较每个战略的ED操作流程。为此，我们将进行一项多中心前瞻性临床试验，采用准实验等效时间样本设计来验证以下假设：(1)与传统的靶向快速HIV筛查和非靶向快速HIV筛查相比，使用DHRS识别高危患者的靶向快速HIV筛查与新的HIV诊断显著相关；(2)有针对性的HIV快速筛查比无针对性的HIV快速筛查更具成本效益；(3)与非靶向HIV快速筛查相比，靶向HIV快速筛查对ED治疗过程没有显著影响。我们将利用一支优秀的跨学科研究团队，对急诊科的HIV筛查进行最大规模、最全面的评估。结果将大大提高我们对如何在急诊科和主要服务不足的人群中提供有效和高效的快速艾滋病毒筛查的理解，并将为其他高风险护理机构的类似做法提供参考。

DESCRIPTION (provided by applicant): Early identification of undiagnosed HIV infection is a critical public health priority. In the United States, despite several substantial HIV-related publc health initiatives, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented. In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ¿0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations. Led by Jason Haukoos, MD, MSc, our research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by clinicians. Our team also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence. To build on this work, we propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 modern rapid HIV screening strategies when fully-integrated into routine ED care; (2) to measure and compare program costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each strategy. In doing so, we will perform a multi-center prospective clinical trial using a quasi-experimental equivalent time-samples design to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) targeted rapid HIV screening does not significantly impact ED processes of care when compared to nontargeted rapid HIV screening. We will leverage an outstanding interdisciplinary research team to conduct the largest and most comprehensive evaluation of HIV screening in EDs. The results will substantially improve our understanding of how to provide effective and efficient rapid HIV screening in EDs and to predominantly underserved populations, and will inform similar practices in other high-risk care settings.