Clinical trial NCT04429971: Pre-Exposure Prophylaxis in the Emergency Department
Official title: Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
PrEP
Keywords: Feasibility
Implementation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
Primary purpose: SCREENING

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 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.

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-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool.
2. 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.

1. 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.
2. 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.

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

Primary outcomes:
measure: Time to completion of ED PrEP screening (Implementation Component)
timeFrame: 30 days post-ED visit
measure: Engagement in care (Implementation Component)
timeFrame: 30 days post-ED visit
Secondary outcomes:
measure: PrEPPED Satisfaction and Acceptability Survey (RCT Component)
timeFrame: 30 days post-ED visit
measure: The VSQ-9 is a visit-specific satisfaction instrument (RCT Component)
timeFrame: 30 days post-ED visit
measure: CDC Sexual Behavior Questions (CSBQ) (RCT Component)
timeFrame: 30 days post-ED visit
measure: Number of new STI diagnoses (RCT Component)
timeFrame: 30 days post-ED visit
measure: Number of new HIV Infection (RCT Component)
timeFrame: 30 days post-ED visit
measure: Visit Rating Questionnaire (VSQ9) (RCT Component)
timeFrame: 30 days post-ED visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ethan Cowan, MD
role: PRINCIPAL_INVESTIGATOR
References: