ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments Patients: a Two-arm Hybrid Implementation-effectiveness Trial

简要总结

详细描述

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 different strategies for increasing PrEP uptake among patients at risk for HIV accessing STI care in Bronx EDs. The two strategies are (1) Post-Visit Outreach (PVO) involving proactive outreach to patients following a sexual health-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-sexual health (TSH) will involve a real-time telehealth visit with a Sexual Health Provider during sexual health-related ED visits. TSH will also include education, counseling, and linkage, in addition to the provider's ability to prescribe PrEP at the time of the visit. The project will compare the effectiveness of two strategies implemented at two different EDs for 9 months. After the first 9-month study period (Months 1-9), there will be a 1-month wash-out period (Month 10). The study team will then switch the strategies at the two ED study sites for a second 9-month study period (Months 11-19). The trial duration is approximately 31 months total which includes the two-arm implementation-effectiveness trial (19 months) and a follow-up period (12 months). Throughout the study period, the study team will collect quantitative and qualitative data to inform implementation outcomes. Patients will receive TSH the same day of their ED visit or PVO within 7 days of their ED visit. All patients 18+ years old presenting to one of the ED study sites with sexual health-related complaints who fulfill eligibility criteria will be included in the two-arm trial. For this pragmatic trial, no individual participant recruitment is needed, as all relevant outcome data and covariates are routinely collected as part of clinical care and will be extracted from the electronic health record (EHR) using standard extraction procedures and New York City Department of Health and Mental Hygiene (NYC DOHMH) HIV Registry. To ensure that both ED sites are equally prepared to implement TSH, the ED site starting with TSH will receive TSH-specific trainings one week prior to the launch of the trial. For the ED site implementing TSH in the second trial period, the study team will practice TSH workflows and procedures with a clinical champion during the one-month wash-out period. Because the PVO strategy involves outreach by a Sexual Health Navigator (SHN) (not a member of ED staff) only after an ED visit is completed with no other involvement from ED staff, no ED-specific trainings are needed for this strategy. The overall study will also include an implementation science study (quantitative and qualitative sub-studies), an economic and cost analysis and seroconversion ascertainment. The trial period will be preceded by a 3-month Optimization Phase to standardize study workflows and procedures. This registration is specific to the two-arm trial of the study protocol.

主要结局

次要结局

• PrEP Uptake(Within 6 and 12 months after index ED visit)
• Post-exposure prophylaxis (PEP) initiation(At the time of ED visit (baseline))
• Confirmation of HIV testing(At the time of ED visit (baseline))
• Confirmation of HIV and STI testing(Within 6 months after index ED visit)
• Linkage to status neutral healthcare(Within 3 months after index ED visit)
• Retention in PrEP(Within 6 months and 12 months after initial PrEP prescription)
• Incident HIV Diagnoses(Up to ~19 months after index visit (at end of study period))
• PrEP Persistence(6 months and 12 months after initial PrEP prescription)
• HIV Viral RNA levels(3 and 12 months after index ED visit)