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HIV感染。尽管为改进对未确诊艾滋病毒感染者的识别作出了重大努力，但过去十年来这一比率变化甚微，新感染者似乎在非传统风险群体中增加得最多，包括少数种族和族裔。大多数艾滋病毒感染者直到病程后期才接受检测，主要原因是无症状期很长，而且他们获得常规医疗的机会相对较少。每年有超过1亿人到急诊科就诊，而艾德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，最有可能将艾德作为唯一护理来源的患者往往是艾滋病毒流行病传播最快的患者。拟议研究的主要目的是证明临床有效性，临床效率，成本效益和患者-工作人员满意度进行常规自愿退出快速艾滋病毒CTR在高容量的城市艾德，相比，有针对性的快速艾滋病毒CTR计划在相同的设置。拟议研究的主要假设是，选择退出快速HIV CTR与总体检测率较高、HIV感染患者的识别、HIV感染患者病程早期的识别以及HIV感染检测阳性患者的医疗和预防护理成功联系相关。次要假设是，选择退出的快速HIV CTR：（1）与增加的艾德护理过程无关，由患者等待时间、住院时间、在完成评估前离开的患者比例和过度拥挤指数定义;（2）具有成本效益。第三个假设是，选择退出快速HIV CTR与患者和艾德工作人员的满意度较高。为了解决这些假设，我们将进行一项前瞻性准实验性等效时间样本临床试验，其中在干预期间到艾德就诊的连续患者将作为其访视的一部分选择退出快速HIV CTR，在对照期间，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。从这项研究中获得的结果将提高我们对如何最好地识别艾德中的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.