CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
PrEP screening program +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04429971
NCT04429971N/ACompleted

Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study

Icahn School of Medicine at Mount Sinai·interventional·Posted Jun 12, 2020·Updated Dec 9, 2025

In Brief

A clinical study evaluating PrEP screening program and PrEP starter pack for HIV/AIDS and PrEP. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS, PrEP
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 12, 2020
Enrollment StartMar 18, 2020
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.1 years ago

Interventions

PrEP screening programother

ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

PrEP starter packother

emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil