Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV/AIDS
  • PrEP
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participantsMasking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability. Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool. During a 3-month period, use c...

Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability. Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool. During a 3-month period, use continuous quality improvement methods to decrease the time for completion of PrEP eligibility screening to an interval that is acceptable to ED patients and providers. Aim 2: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial: Identify 40 PrEP eligible patients over a 12-month period who are interested in initiating PrEP in the ED. These patients will be offered immediate PrEP (iPrEP) initiation in the ED with facilitated linkage to comprehensive out-patient care. Evaluate the impact of a PrEP "starter pack" on patients agreeing to iPrEP. The primary outcome is engagement in care at 30-days post PrEP initiation visit. Secondary outcomes include retention in care, STI diagnosis, risk behavior and PrEP adherence. Collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated PrEP.

Tracking Information

NCT #
NCT04429971
Collaborators
Not Provided
Investigators
Principal Investigator: Ethan Cowan, MD Icahn School of Medicine at Mount Sinai