N/A N=26 Screening

Pre-Exposure Prophylaxis in the Emergency Department

HIV/AIDS · PrEP

Bottom Line

View on ClinicalTrials.gov: NCT04429971 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2025

Primary outcome: Primary: Engagement in Care (Implementation Component) — 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PrEP screening program (Other); PrEP starter pack (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Engagement in Care (Implementation Component)	1; 1	—
PRIMARY Number of Participants on PrEP Usage	1; 2	—
SECONDARY PrEPPED Satisfaction and Acceptability Survey (RCT Component)	—	—
SECONDARY The VSQ-9 is a Visit-specific Satisfaction Instrument (RCT Component)	—	—
SECONDARY CDC Sexual Behavior Questions (CSBQ) (RCT Component)	4; 5; 2; 2; 0; 0	—
SECONDARY Number of Participants of New STI Diagnoses (RCT Component)	1; 2; 0; 0; 0; 0	—
SECONDARY Number of Participants of New HIV Infection (RCT Component)	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

PrEP screen group:

Patients 18 years of age and above
Medically stable as determined by their provider
Able to speak English
Willing and able to consent to study participation.
Not requiring hospital admission for ongoing care.

iPrep group:

ED patients 18 years of age and above
HIV negative determined by 4th generation rapid testing with no evidence of acute HIV infection as determined by their ED provider
Medically stable as determined by their primary provider
Able to speak English
Able to consent to participation
Contact information available for linkage
Not requiring hospital admission for ongoing care.
Eligible for PrEP based on CDC risk behavior and clinical criteria.

Exclusion Criteria

PrEP screen group:

ED patients younger than 18 years of age
Medically or psychiatrically unstable as determined by the ED provider
Unable to speak or understand English
Unable to provide consent for study participation.
Being admitted to the hospital for ongoing care

iPrEP group:

ED patients younger than 18 years of age
Known HIV positive or positive rapid HIV test in ED
Medically or psychiatrically unstable as determined by the ED provider
Unable to speak or understand English
Unable to provide consent for study participation
No means of re-contact upon ED discharge
No behavioral risk factors indicating need for PrEP
Medical contraindications to PrEP
Pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04429971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.