A Randomized Controlled Trial of HIV Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED).

Background: Oral human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) effectively reduces HIV transmission. However, PrEP remains underutilized due to structural, provider, and individual-level barriers, with significant disparities in access. Emergency departments (EDs) serve high-risk populations often disconnected from primary care, offering a strategic setting for initiating PrEP services. In spite of the potential, ED-based PrEP programs face challenges, and the feasibility of initiating PrEP in this setting is unclear.

Objectives: This pilot randomized controlled trial (RCT) aimed to evaluate the impact of immediate PrEP initiation (iPrEP) in the ED on PrEP usage at 90 days.

Methods: The trial randomized eligible ED patients 1:1 to iPrEP in the ED with a 28-day starter pack given at discharge vs. referral for outpatient PrEP initiation. Participants were followed for 90 days, with the primary outcome being PrEP usage. Secondary outcomes were PrEP usage at 30 and 60 days, retention in care at 30, 60, and 90 days, HIV risk, and satisfaction.

Results: Of 1455 patients screened, 169 were eligible, 27 were randomized, and 26 received their assigned intervention. At 90 days, only 3 participants were taking PrEP (2 iPrEP, 1 referral). Follow-up at 30, 60, and 90 days revealed no significant differences between the groups for any secondary outcome.

Conclusions: PrEP initiation in the ED did not improve PrEP usage or retention in care compared with referral alone. Despite high satisfaction with the screening process, barriers to ED-based PrEP initiation, including low interest and awareness, persisted.