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.

黑人和拉丁裔人群在艾滋病毒暴露前预防 (PrEP) 的获取和使用方面仍然存在严重不平等 受艾滋病毒流行影响最严重的社区。纽约州布朗克斯区，超过 90% 的人口认为 作为黑人或拉丁裔，是结束艾滋病毒流行 (EHE) 优先县，艾滋病毒诊断率排名第五 美国的 PrEP 使用率最低，纽约州的 PrEP 使用率最低。对 PrEP 参与障碍的研究表明，目前 PrEP 获取和管理的结构与最困难人群的生活、优先事项或需求不相符 袭击社区，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。 导致黑人/拉丁裔社区的 PrEP 吸收率低下的许多相同障碍也驱使成员 这些社区寻求性传播感染 (STI) 护理，性传播感染是艾滋病毒的已知危险因素， 急诊科 (ED)。然而，可能保留的护理类型之间存在不一致 那些在急诊科寻求性传播感染护理的人的长期健康状况（纵向、行为和预防导向）以及 急诊室经过优化可提供的护理（急性、高强度、挽救生命/稳定），这意味着两名患者 急诊室提供性传播感染护理的方式的重组将使卫生系统受益。创新、高效、 确定和吸引高优先人群参与艾滋病毒预防的可持续战略 因此，急诊科需要性保健。因此，我们提出 ED2PrEP，一种实用的 III 型混合体 比较两种提高高危患者 PrEP 摄取率的策略的有效性实施试验 帮助艾滋病毒在布朗克斯急诊室获得护理。这两种策略是 (1) 访问后外展 (PVO)，涉及主动 在与性传播感染相关的急诊就诊后对患者进行外展。 PVO 将由性健康导航员发起，他 将提供 PrEP 教育、咨询以及与现有性健康/PrEP 诊所的联系。 (2) 远程PrEP (TP) 将涉及在性传播感染相关急诊就诊期间与性健康提供者进行实时远程医疗就诊。 TP也会 除了提供者在治疗时开具 PrEP 处方的能力之外，还包括教育、咨询和联系 这次访问。测试 PVO 和 TP 对增加 STI 患者 PrEP 摄取的有效性 在急诊室的护理中，我们将进行交叉试验，在两个不同的急诊室实施这些策略 9 个月，然后再切换 9 个月（目标 1）。接下来，我们将在 RE-AIM 框架的指导下 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 实施考虑因素（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策略的每个结果的成本和相对成本效益（目标 3）。 ED2PrEP 将生成关键数据，这些数据可以改变 ED 启动 PrEP 并让人群参与的方式 艾滋病毒风险最高，并加速美国受灾最严重的司法管辖区实现 EHE 目标。研究结果也可能是 为其他司法管辖区提供信息，对如何预防艾滋病毒产生巨大影响。