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: 10653035
• 负责人: Uriel Felsen
• 金额: $ 90.07万
• 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/10653035
• 关键词: AIDS prevention; Acceleration; Accident and Emergency department; Acute; Address; Adoption; Behavioral; Black race; Caring; Clinic; Communities; Counseling; County; Cross-Over Trials; Data; Education; Effectiveness; Elements; Eligibility Determination; Emergency Care; Emergency Department patient; Emergency department visit; Epidemic; Equipoise; Geography; Goals; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV risk; Health; Health Personnel; Health Services Accessibility; Health system; Healthcare; Healthcare Systems; Incidence; Inequity; 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; Sexual Health; Sexually Transmitted Diseases; Structure; Testing; Time; Viral; Visit; acceptability and feasibility; budget impact; care seeking; cost; cost effectiveness; design; economic evaluation; effectiveness testing; effectiveness/implementation trial; ethnic disparity; 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; prevent epidemics; preventive intervention; primary outcome; racial disparity; relative cost; scale up; secondary outcome; 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.

在黑人和拉丁美洲人中，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 受艾滋病毒流行影响最严重的社区。纽约州的布朗克斯，超过90%的人口认为 作为黑人或拉丁裔，是一个结束艾滋病毒流行（EHE）的优先县，艾滋病毒诊断率第五高 在美国和最低的PrEP使用在纽约。对PrEP参与障碍的研究表明，当前 PrEP获取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感染率方面的种族/族裔和社会经济差异。 导致黑人/拉丁裔社区PrEP吸收不良的许多相同障碍也促使 这些社区寻求治疗性传播感染（STIs），这是艾滋病毒的一个已知风险因素， 急诊科（ED）。然而，在可能保留的护理类型之间存在不一致， 在ED中寻求STI护理的人的长期健康状况（纵向，行为和预防导向）， 艾德提供的最佳护理（急性、高强度、挽救生命/稳定），这意味着两名患者 卫生系统将从如何在急诊室提供STI护理的重组中获益。创新、高效、 确定和动员高度优先人群参与艾滋病毒预防工作的可持续战略 因此，需要ED中的性保健。因此，我们提出了ED 2 PrEP，一种实用的III型混合物， 有效性实施试验，比较两种策略，以增加风险患者的PrEP摄取 在布朗克斯急诊室接受治疗。这两项战略是（1）访视后外联（PVO）， 对STI相关艾德访视后的患者进行外展。PVO将由一名性健康导航员发起， 将提供PrEP教育，咨询，并与现有的性健康/PrEP诊所联系。(2)远程PrEP（TP） 将涉及在性传播感染相关的艾德就诊期间与性健康提供者进行实时远程健康就诊。TP还将 包括教育，咨询，和联系，除了提供者的能力，规定PrEP的时间， 这次访问。测试PVO和TP增加接受STI治疗的患者中PrEP摄取的有效性 在艾德的护理中，我们将进行一项交叉试验，其中在两个不同的ED中实施策略 9个月，然后再换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： 实施考虑（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 经济分析，以确定每个战略的成本单位成果和相对成本效益（目标3）。 ED 2 PrEP将生成关键数据，这些数据可能会改变ED如何启动PrEP并在 艾滋病毒风险最高，并加快美国受打击最严重的司法管辖区的EHE目标调查结果也可能是 为其他司法管辖区提供信息，对如何提供艾滋病毒预防产生巨大影响。