ED2PrEP - patient focused, low-burden strategies for PrEP uptake among emergency departments patients: a cross-over hybrid implementation-effectiveness trial

ED2PrEP - 以患者为中心的、急诊科患者采用 PrEP 的低负担策略：交叉混合实施效果试验

• 批准号: 10459999
• 负责人: Uriel Felsen
• 金额: $ 82.05万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-24 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10459999
• 关键词: AIDS prevention; Accident and Emergency department; Acute; Address; Adoption; Behavioral; Black race; Caring; Clinic; Communities; Counseling; County; Cross-Over Trials; Data; Education; Effectiveness; Elements; Emergency Care; Emergency Department patient; Emergency department visit; Epidemic; Equipoise; Geography; Glare; Goals; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV risk; Health; Health Personnel; Health Services Accessibility; Health system; Healthcare; Healthcare Systems; Incidence; Knowledge; Latino; Latinx; Latinx population; Life; Maintenance; Modeling; Newly Diagnosed; Outcome; Patients; Persons; Population; Populations at Risk; Prevention; Proctor framework; Provider; Reach Effectiveness Adoption Implementation and Maintenance; Research; Risk; Risk Factors; Savings; Sexual Health; Sexually Transmitted Diseases; Structure; Testing; Time; Viral; Visit; base; budget impact; care seeking; cost; cost effectiveness; design; economic evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness testing; effectiveness trial; evidence base; health equity promotion; high risk; implementation determinants; implementation evaluation; implementation outcomes; implementation science; innovation; medical specialties; member; outreach; pre-exposure prophylaxis; preservation; prevent; preventive intervention; primary outcome; racial and ethnic disparities; relative cost; scale up; secondary outcome; sexual HIV transmission; socioeconomic disparity; telehealth; trial comparing; uptake

Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use persist among Black and Latinx communities most impacted by the HIV epidemic. The Bronx, NY, with over 90% of the population identifying as Black or Latinx, is an Ending the HIV Epidemic (EHE) priority county with the fifth highest HIV diagnosis rate in the U.S. and the lowest PrEP use in NY. Research on barriers to PrEP engagement indicate that the current structure of PrEP access and management is not consonant with the lives, priorities, or needs of the hardest hit communities, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. Many of the same barriers leading to poor PrEP uptake in Black/Latinx communities also drive members of these communities to seek care for sexually transmitted infections (STIs), a known risk factor for HIV, in Emergency Departments (EDs). However, there is a discordance between the type of care likely to preserve the long-term health of those seeking STI care in EDs (longitudinal, behavioral, and prevention-oriented) and the care the ED is optimized to provide (acute, high intensity, life-saving/stabilizing), meaning that both patients and health systems stand to gain from a restructuring of how STI care is delivered in EDs. Innovative, efficient, and sustainable strategies for identifying and engaging high priority populations for HIV prevention seeking sexual healthcare in EDs are thus needed. We therefore propose ED2PrEP, a pragmatic Type III hybrid effectiveness-implementation trial comparing two strategies for increasing PrEP uptake among patients at risk for HIV accessing care in Bronx EDs. The two strategies are (1) Post-Visit Outreach (PVO) involving proactive outreach to patients following a STI-related ED visit. PVO will be initiated by a Sexual Health Navigator who will provide PrEP education, counseling, and linkage to existing sexual health/PrEP clinics. (2) Tele-PrEP (TP) will involve a real-time telehealth visit with a Sexual Health Provider during STI-related ED visits. TP will also include education, counseling, and linkage, in addition to the provider’s ability to prescribe PrEP at the time of the visit. To test the effectiveness of PVO and TP for increasing PrEP uptake among patients accessing STI care in the ED, we will perform a crossover trial in which the strategies are implemented in two different EDs for 9 months and then switched for another 9 months (Aim 1). Next, guided by the RE-AIM framework, we will assess implementation outcomes for the strategies to identify how each strategy’s effectiveness is impacted by implementation considerations (Aim 2). Finally, to inform scale-out locally and nationally, we will perform an economic analysis to determine each strategy’s cost per outcome and relative cost-effectiveness (Aim 3). ED2PrEP will generate critical data that could transform how EDs initiate PrEP and engage populations at the highest risk for HIV and accelerate EHE goals in one hardest hit jurisdictions in the U.S. Findings could also be informative to other jurisdictions, having dramatic effects on how HIV prevention is delivered.

在黑人和拉丁裔中，艾滋病毒暴露前预防(PrEP)的获取和使用仍然存在严重的不平等 受艾滋病毒疫情影响最大的社区。纽约州布朗克斯区，超过90%的人口认为 作为黑人或Latinx，是结束艾滋病毒流行(EHE)优先县，艾滋病毒诊断率排名第五 在美国，在纽约PrEP使用量最低。对PrEP参与障碍的研究表明，当前 PrEP访问和管理的结构与最困难的人的生活、优先事项或需求不一致 这进一步加剧了艾滋病毒发病率方面持续存在的种族/族裔和社会经济差异。 许多同样的障碍导致黑人/拉丁裔社区的PrEP接受率很低，也推动了 这些社区寻求性传播感染(STI)的护理，性传播感染是艾滋病毒的已知风险因素， 急诊科(EDS)。然而，在可能保留的护理类型之间存在不一致 急诊室求助性传播感染患者的长期健康(纵向、行为和预防为主)和 急诊室优化提供的护理(急性、高强度、救命/稳定)，这意味着两名患者 而卫生系统将从急诊室提供STI护理的方式的重组中受益。创新、高效、 为寻求艾滋病毒预防而确定和吸引高优先人群参与的可持续战略 因此，急诊室的性保健是必要的。因此，我们提出了ED2PrEP，一种语用类型III混合体 两种增加高危患者PrEP摄取率的有效性-实施试验比较 在布朗克斯区急诊室为HIV患者提供护理。这两种策略是(1)访问后外展(PVO)，涉及主动 在性传播感染相关急诊室就诊后对患者的外展服务。PVO将由性健康导航员发起 将提供PrEP教育、咨询以及与现有的性健康/PrEP诊所的联系。(2)Tele-PrEP(TP) 将包括在性传播感染相关的急诊室就诊期间与性健康提供者进行实时远程健康访问。TP也将 包括教育、咨询和联系，此外，提供者还有能力在 这次访问。测试PVO和TP促进STI患者PrEP摄取的有效性 在急症室护理方面，我们会进行一项交叉试验，在两间不同的急症室实施策略 9个月，然后又换了9个月(目标1)。接下来，在RE-AIM框架的指导下，我们将 评估战略的实施结果，以确定每个战略的有效性如何受到以下因素的影响 执行方面的考虑(目标2)。最后，为了向本地和全国范围内的横向扩展提供信息，我们将执行 进行经济分析，以确定每项战略的每项成果成本和相对成本效益(目标3)。 ED2PrEP将生成关键数据，这些数据可能会改变ED启动PrEP和在 在美国受影响最严重的司法管辖区之一，艾滋病毒风险最高，加速EHE目标。调查结果也可能是 向其他司法管辖区提供信息，对如何提供艾滋病毒预防产生重大影响。