Pre-Exposure Prophylaxis in the Emergency Department

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04429971
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PrEP screening program — OTHER
    ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
  • PrEP starter pack — OTHER
    emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil

Study Details

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.

Key Dates

Start date
Mar 18, 2020
Status verified
Nov 2025
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Immediate PreP initiation
    PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.
  • Active Comparator: Out-patient care for PrEP initiation
    PrEP screening program with referral to out-patient care for PrEP initiation
  • Experimental: PreP Screening Program
    Part 1: Targeted ED-based patients

Primary Outcome Measure

Engagement in Care (Implementation Component) [ Time Frame: 30 days post-ED visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Beth Israel HospitalNew YorkNew York10003-

Find similar trials in New York, NY

By condition
HIV
By specialty
Infectious disease
By research site
Mount Sinai Beth Israel Hospital· New York, NY

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