Pre-Exposure Prophylaxis in the Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study

Conditions
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HIV/AIDS, PrEP

Intervention / Treatment
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* Other: PrEP screening program
* Other: PrEP starter pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate PreP initiation<br>PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP starter pack with facilitated linkage to care. | Other: PrEP screening program<br>* ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool<br>Other: PrEP starter pack<br>* emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil<br>|
| Active Comparator: Out-patient care for PrEP initiation<br>PrEP screening program with referral to out-patient care for PrEP initiation | Other: PrEP screening program<br>* ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool<br>|
| Experimental: PreP Screening Program<br>Part 1: Targeted ED-based patients | Other: PrEP screening program<br>* ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to completion of ED PrEP screening (Implementation Component) | Time to completion of screening will be calculated from the time of the patient's first contact with a health educator to the time to completion of all laboratory screening tests. | 30 days post-ED visit | 
| Engagement in care (Implementation Component) | Engagement is care is defined by attending at least 1 out-patient clinic appointment with a PrEP provider within 30-days of the ED visit. | 30 days post-ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEPPED Satisfaction and Acceptability Survey (RCT Component) | PrEPPED Satisfaction and Acceptability Survey is a patient satisfaction questionnaire was developed by the study team. It's a series of independent Likert questions from 1-6 addressing different aspects of the program. Full scale from 0 to 18, with higher score indicating more satisfaction. | 30 days post-ED visit | 
| The VSQ-9 is a visit-specific satisfaction instrument (RCT Component) | The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Guidelines Regimen Information Program (GRIP) survey. GRIP guide is a self-report to assess PrEP adherence at 30-days post ED visit, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. | 30 days post-ED visit | 
| CDC Sexual Behavior Questions (CSBQ) (RCT Component) | CDC Sexual Behavior Questions (CSBQ) to measure HIV risk behavior. CSBQ is a multi-tiered, gender-specific questionnaire developed by the Centers for Disease Control and Prevention HIV-STID Behavioral Surveillance Working Group. Three separate domains - Sexual Behavior, Drug-related HIV risk, and HIV testing. Responses are yes/no with no summation. | 30 days post-ED visit | 
| Number of new STI diagnoses (RCT Component) | Number of new STI diagnosis at 30-days | 30 days post-ED visit | 
| Number of new HIV Infection (RCT Component) | Number of new HIV diagnosis at 30-days | 30 days post-ED visit | 
| Visit Rating Questionnaire (VSQ9) (RCT Component) | The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Group Association from the Visit Rating Questionnaire. Total scale from 0 to 100 with higher score indicating more satisfaction | 30 days post-ED visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility, Implementation