Skip to main content
OpenTrials
Completed

NCT Number: NCT04429971

Pre-Exposure Prophylaxis in the Emergency Department

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections PreP RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Beth Israel Hospital

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Engagement in Care (Implementation Component)

    Time frame: 30 days post-ED visit

    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.

  2. Number of Participants on PrEP Usage

    Time frame: 90 days

Secondary outcomes

  1. PrEPPED Satisfaction and Acceptability Survey (RCT Component)

    Time frame: 30 days post-ED visit

    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.

    Satisfaction data were not collected at 30, 60, or 90 days. After study initiation, it was determined by the researchers that the satisfaction items were specific to the emergency department visit experience and not relevant to the follow-up period. Consequently, decision was made to not administer the follow-up satisfaction assessments, therefore, no data was collected so there is no data to report.

  2. The VSQ-9 is a Visit-specific Satisfaction Instrument (RCT Component)

    Time frame: 30 days post-ED visit

    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.

    Because participants were not required to follow up at a single clinic, post-discharge care settings varied widely. The VSQ-9 assesses satisfaction with a specific clinical encounter, and applying it across multiple, non-standardized settings was deemed inappropriate and unlikely to yield interpretable data. Therefore, decision was made by the researcher to not administer the VSQ-9 at 30, 60, or 90 days. Consequently, no follow-up VSQ-9 data were collected so there is no data to report.

  3. CDC Sexual Behavior Questions (CSBQ) (RCT Component)

    Time frame: 30 days post-ED visit

    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.

    Number of participants who engaged in unsafe sexual behavior, was under substance influence and who had a HIV test.

  4. Number of Participants of New STI Diagnoses (RCT Component)

    Time frame: 30 days, 60 days, and 90 days post-ED visit

    Number of new STI diagnosis between day 1 (day after enrollment) and day 90 (final day of follow-up) broken down into days 1-30, 31-60, 61-90.

  5. Number of Participants of New HIV Infection (RCT Component)

    Time frame: 90 days post-ED visit

    Number of new HIV diagnosis at 90-days after enrollment. This question was only asked for those individuals who had not been lost to follow-up.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: PrEPPED

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2020
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.