ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments

Study Overview
=================
Brief Summary
-----------------
Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use in communities hardest hit by the HIV epidemic persist, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. In these same communities, many patients at risk for HIV seek care for sexually transmitted infections (STIs) in Emergency Departments (EDs), but the structure of traditional ED care is poorly suited to address HIV prevention or provide PrEP. To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.

Detailed Description
-----------------
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. The study team therefore proposes 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, the study team 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, the study team 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, the study team 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.

Official Title
-----------------
ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments Patients: a Cross-over Hybrid Implementation Effectiveness Trial

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: PVO
* Behavioral: TS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older; visit to the Emergency Department, has a sexual health related concern Exclusion Criteria: unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post Visit Outreach<br>Outreach by trained patient navigators/educators after patients' ED visit for education, counseling, linkage to preventive/sexual health care. | Behavioral: PVO<br>* post-visit outreach<br>|
| Experimental: Tele-Sexual Healthcare<br>Tele-sexual health visit with a specialist offered during the ED visit to patients. | Behavioral: TS<br>* tele-sexual health visit during the ED visit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Uptake | Prescription of any medication to be used as HIV PrEP, captured in the electronic health record. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Uptake at 6 months | Prescription of any medication to be used as HIV PrEP, captured in the electronic health record. | 6 months | 
| PrEP Uptake at 12 months | Prescription of any medication to be used as HIV PrEP, captured in the electronic health record. | 12 months | 
| Linkage to status neutral healthcare | Attending a clinical appointment for sexual healthcare or related to HIV, captured in the electronic health record | 3 months | 
| Linkage to status neutral healthcare | Attending a clinical appointment for sexual healthcare or related to HIV, captured in the electronic health record | 12 months | 
| HIV and STI testing | Receipt of tests for HIV and sexually transmitted infections (gonorrhea and chlamydia from any anatomic site, or syphilis) after the emergency department visit, captured in the electronic health record. | 6 months | 
| PrEP Persistence | Composite data from the electronic health record about having a prescription for PrEP medications and survey responses about current PrEP use. | 6 months | 
| PrEP Persistence | Composite data from electronic health record about having a prescription for PrEP medications and survey responses about current PrEP use. | 12 months | 
| HIV Viral RNA levels | Laboratory quantification of circulating HIV virus among individuals diagnosed with HIV in the study. | 3 months | 
| HIV Viral RNA levels | Laboratory quantification of circulating HIV virus among individuals diagnosed with HIV in the study. | 12 months | 
| Incident HIV Diagnosis | Diagnosis of HIV based on multiple data sources (electronic health record, surveys) occurring at anytime starting from ED visit through end of study period. | 18 months |