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

描述（由申请人提供）：美国每年估计有40,000例新的艾滋病毒感染。尽管在改进对未确诊的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几乎没有变化，新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。大多数艾滋病毒感染者直到病程晚期才接受检测，主要原因是无症状期较长，而且他们获得常规医疗护理的机会相对较少。每年有超过1亿人访问急诊科（ED），急诊科通常是患者获得医疗护理的唯一来源，因此也是接受艾滋病毒咨询、检测和转诊（CTR）的唯一潜在机会。此外，最有可能将急诊科作为唯一护理来源的患者往往是那些艾滋病毒传播最严重的患者。拟议研究的主要目的是证明在大容量城市急诊科执行常规自愿退出快速HIV CTR的临床有效性、临床效率、成本效益和患者-员工满意度，并将其与相同环境下的定向快速HIV CTR项目进行比较。拟议调查的主要假设是，选择退出快速艾滋病毒CTR与较高的总体检测率、确定感染艾滋病毒的患者、在其疾病过程中较早确定感染艾滋病毒的患者以及成功地将艾滋病毒感染检测呈阳性的患者与医疗和预防性护理联系起来有关。次要假设是，选择退出快速HIV CTR:(1)与ED治疗过程的增加无关，该过程由患者等待时间、住院时间、在完成评估之前离开的患者比例和过度拥挤指数定义；(2)性价比高。第三种假设是，选择退出快速HIV CTR与更高水平的患者和ED工作人员满意度相关。为了解决这些假设，我们将进行一项前瞻性准实验等效时间样本临床试验，在干预期间连续出现在急诊科的患者将被提供选择退出的快速HIV CTR作为其就诊的一部分，在控制期间，医生将使用先前开发和验证的CTR模型对患者进行快速HIV CTR。从这项研究中获得的结果将提高我们对如何最好地识别ED中HIV感染患者的理解，以及选择退出快速HIV CTR是否是实现CDC在其病程早期识别更多无症状HIV感染患者的目标的有效手段。

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.