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.

HIV暴露前预防（PREP）的严重不平等（PREP）访问并使用黑色和拉丁裔 受艾滋病毒流行影响最大的社区。布朗克斯，纽约，超过90％的人口识别 作为黑色或拉丁裔，是HIV流行（EHE）优先级的结尾，HIV诊断率是第五高 在美国，是纽约州最低的准备使用。关于准备障碍的研究，表明当前 准备访问和管理的结构与最难的生命，优先事项或需求不符 击中社区，进一步加剧了正在进行的种族/种族和艾滋病毒事件中的社会经济差异。 许多相同的障碍导致黑人/拉丁裔社区的预期吸收不良，也驱动了 这些社区寻求照顾性传播感染（STI），这是艾滋病毒的已知危险因素， 急诊科（EDS）。但是，可能保留的护理类型之间存在不一致 在EDS（纵向，行为和以预防为导向的行为）中寻求STI护理的人的长期健康 ED的护理被优化以提供（急性，高强度，挽救生命/稳定），这意味着两个患者 卫生系统将从恢复EDS提供STI护理的恢复中获得。创新，高效， 以及可持续的策略，以识别和参与高优先级人群以寻求艾滋病毒 因此，需要在ED中进行性医疗保健。因此，我们提出了ED2PREP，一种务实的III型混合动力车 有效实施试验比较了增加风险患者的预备摄取的两种策略 用于艾滋病毒在布朗克斯编辑中获得护理。这两种策略是（1）涉及积极主动的访问后推广（PVO） 与性传播感染相关的ED访问后，向患者推广。 PVO将由性健康导航员发起 将提供预科教育，咨询和与现有性健康/预科诊所的联系。 （2）Tele-Prep（TP） 将在与性别健康相关的ED访问期间与性健康提供商进行实时远程医疗访问。 TP也将 除了提供商在准备时准备准备的能力外，还包括教育，咨询和联系 访问。测试PVO和TP的有效性，以增加进入STI的患者的PREP摄取 在ED中，我们将进行一项跨界试验，其中在两种不同的ED中实施策略 9个月，然后再切换9个月（AIM 1）。接下来，在Re-Aim框架的指导下，我们将 评估策略的实施结果，以确定每个策略的有效性如何受到影响 实施注意事项（AIM 2）。最后，为了在本地和全国范围内通知大规模，我们将执行 经济分析以确定每种策略的每个结果和相对成本效益的成本（AIM 3）。 ED2PREP将生成关键数据，该数据可以改变EDS启动PREP并参与人口的关键数据 在美国，艾滋病毒和加速目标的最高风险也可能是 为其他司法管辖区提供了信息，对预防艾滋病毒的预防产生了巨大影响。