PS06-003, Opt-out HIV Testing in Emergency Dept settings

描述(由申请人提供)：据估计，美国每年有40,000例新的艾滋病毒感染病例。尽管在改进未确诊艾滋病毒感染者的识别方面作出了重大努力，但这一比率在过去十年中变化很小，新的感染似乎在非传统风险群体中增加最多，包括种族和少数民族。大多数感染艾滋病毒的人直到病程后期才接受检测，这主要是因为艾滋病毒无症状期长，而且他们获得常规医疗服务的机会相对较少。每年有超过1亿人到急诊科就诊，急诊科通常是患者唯一的医疗护理来源，因此也是接受艾滋病毒咨询、检测和转介(CTR)的唯一潜在机会。此外，最有可能使用急诊室作为唯一护理来源的病人，往往是那些艾滋病毒疫情传播最严重的人。拟议研究的主要目标是证明在大容量城市急诊室中进行常规自愿退出快速艾滋病毒CTR的临床有效性、临床效率、成本效益和患者-工作人员满意度，并与相同环境下的有针对性的快速HIV CTR计划进行比较。拟议调查的基本假设是，选择退出快速艾滋病毒CTR与较高的总体检测率、识别艾滋病毒感染患者、在病程较早时识别感染艾滋病毒的患者以及与艾滋病毒感染检测呈阳性的患者的医疗和预防性护理成功挂钩有关。第二个假设是，选择退出快速艾滋病毒CTR：(1)与增加的急诊护理过程无关，由患者等待时间、住院时间、患者在完成评估前离开的比例以及过度拥挤指数定义；以及(2)具有成本效益。第三个假设是，选择退出快速艾滋病毒CTR与患者和急诊室工作人员的满意度水平更高相关。为了解决这些假设，我们将进行一项前瞻性的准实验等量时间样本临床试验，在该试验中，在介入期间到急诊室就诊的连续患者将被提供退出快速HIV CTR作为其就诊的一部分，而在控制期内，医生将使用先前开发和验证的CTR模型针对患者进行快速HIV CTR。这项研究的结果将使我们更好地了解如何最好地在ED中识别艾滋病毒感染患者，以及选择退出快速艾滋病毒CTR是否是实现疾病预防控制中心的目标的有效手段，即在疾病过程中及早识别更多无症状的艾滋病毒感染患者。

DESCRIPTION (provided by applicant): An estimated 40,000 new HIV infections occur annually in the United States. Although significant effort has been devoted to improving identification of patients with undiagnosed HIV infection, this rate has changed very little in the last decade and new infections appear to be increasing most in non-traditional risk groups, including racial and ethnic minorities. Most persons infected with HIV still do not get tested until late in their disease courses, primarily due to its long asymptomatic period and their relatively poor access to routine medical care. Over 100 million people visit emergency departments (EDs) annually, and the ED commonly serves as a patient's only source for medical care, and thus the only potential opportunity to receive HIV counseling, testing, and referral (CTR). Also, patients who are most likely to use the ED as their only source of care are often those for whom the HIV epidemic is spreading most. The primary objective of the proposed research is to demonstrate clinical effectiveness, clinical efficiency, cost effectiveness, and patient-staff satisfaction with performing routine voluntary opt-out rapid HIV CTR in a high-volume urban ED, when compared to a targeted rapid HIV CTR program in the same setting. The primary hypothesis of the proposed investigations is that opt-out rapid HIV CTR is associated with a higher rate of overall testing, identification of patients infected with HIV, identification of patients infected with HIV earlier in their disease courses, and successful linkage into medical and preventative care for those patients who test positive for HIV infection. The secondary hypotheses are that opt-out rapid HIV CTR: (1) is not associated with increased ED processes of care, defined by patient waiting times, length of stays, the proportion of patients who leave before completing their evaluations, and an overcrowding index; and (2) is cost-effective. The tertiary hypotheses are that opt-out rapid HIV CTR is associated with a higher level of patient and ED staff satisfaction. To address these hypotheses, we will perform a prospective quasi-experimental equivalent time-samples clinical trial in which consecutive patients who present to the ED during interventional periods will be offered opt-out rapid HIV CTR as part of their visits, and during the control periods, patients will be targeted by physicians for rapid HIV CTR using a previously developed and validated CTR model. The results obtained from this study will improve our understanding of how best to identify patients with HIV infection in ED, and whether opt-out rapid HIV CTR is an effective means to achieve the CDC's goals of identifying more asymptomatic HIV-infected patients earlier in their disease courses.