Evaluating the Feasibility and Willingness to Start PrEP in an Emergency Department Setting: Protocol for a Hybrid Type I Effectiveness-Implementation Study (Preprint)
Authors: Castel Amanda D , Kulie Paige , Powell Natasha , Payette Christopher , Harcourt Samuel , Baskaran Anuja , McCarthy Melissa L 
Published: August 2023

BACKGROUND

Pre-exposure prophylaxis (PrEP) is an effective biomedical intervention with the potential to reduce HIV incidence. Despite this, PrEP uptake has been slow, especially among the groups at highest risk for acquiring HIV. Novel strategies are needed to improve PrEP awareness, access, uptake and adherence. The Emergency Department (ED) is a unique clinical setting that serves a substantial proportion of people at high-risk of HIV acquisition. Previous work suggests there may be an opportunity for the ED to increase PrEP uptake and improve linkage to HIV preventive care. In this study, we aim to determine the feasibility and acceptability of PrEP delivery in the ED in an urban setting.

OBJECTIVE

This project seeks to demonstrate the feasibility and acceptability of PrEP delivery in an ED in Washington, DC, an urban area with a high HIV prevalence rate. We will implement and assess the impact of our intervention with the goal of using this information to determine if the ED setting is an appropriate clinical setting to offer PrEP to patients at high risk of HIV acquisition.

METHODS

We will conduct a Hybrid Type I effectiveness-implementation study to simultaneously assess the effectiveness of PrEP screening and initiation in the ED as well as collect information to identify the barriers and facilitators of real-world implementation of this strategy for increasing PrEP uptake. We will screen and enroll ED patients with chief complaints or diagnostic tests ordered in the ED indicative of HIV risk. We will offer PrEP education, a 10-day starter pack of either TDF+FTC (Truvada) or TAF+ FTC (Descovy) and arrange a follow-up appointment with a community PrEP provider (CPP) to those who are determined to be PrEP eligible per CDC guidelines following the completion of a self-administered survey and applicable laboratory tests. For PrEP-eligible patients who decline to start PrEP in the ED, we will offer to arrange a referral visit to a CPP. Additionally, we will conduct surveys with study participants and in-depth interviews with participants, ED providers, CPPs, and research staff to identify factors that characterize best practices in implementation of ED PrEP and identify multi-level influencers to adoption of PrEP uptake.

RESULTS

The study was funded in March 2020, however; we did not initiate preparing for implementation until July 2021 due to the COVID-19 pandemic. The protocol was reviewed and approved by the George Washington University Institutional Review Board (NCR213868) on March 18, 2022. Enrollment began on December 1, 2022, and 35 study participants were enrolled when the study was terminated on May 10, 2023.

CONCLUSIONS

This study will offer some of the first data on ED-initiated PrEP uptake and adherence and provide insights into barriers and facilitators to PrEP uptake among patients seeking care in an ED in a high prevalence urban epidemic area. These data will guide our understanding of how best to implement PrEP delivery in ED settings.