Status:
COMPLETED
Pre-Exposure Prophylaxis in the Emergency Department
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
HIV/AIDS
PrEP
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 subsequen...
Detailed Description
Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability. 1. Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04429971
Start Date
March 18 2020
End Date
July 31 2023
Last Update
December 9 2025
Active Locations (1)
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1
Mount Sinai Beth Israel Hospital
New York, New York, United States, 10003