<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04429971</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 19-2596</org_study_id>
    <nct_id>NCT04429971</nct_id>
  </id_info>
  <brief_title>Pre-Exposure Prophylaxis in the Emergency Department</brief_title>
  <acronym>PrEPPED</acronym>
  <official_title>Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods,&#xD;
      since 2010 rates of new infection have remained around 40,000 annually. The demonstrated&#xD;
      efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for&#xD;
      pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning&#xD;
      point that could significantly reduce the number of new infections. Since approval, the&#xD;
      promise of PrEP as a transformative intervention has yet to be realized. Despite the&#xD;
      implementation of systems for clinical evaluation for and initiation of PrEP by primary care&#xD;
      providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been&#xD;
      identified, including: 1) patient and provider lack of knowledge, 2) lack of access to&#xD;
      medical care among high-risk individuals, 3) provider discomfort and inexperience with&#xD;
      screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to&#xD;
      expand access to and engagement in PrEP among high risk individuals though an innovative&#xD;
      delivery approach in the Emergency Department (ED) while addressing these four barriers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and&#xD;
      acceptability.&#xD;
&#xD;
        1. Behavioral risk factor eligibility screening will be performed using the ICAP&#xD;
           Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool.&#xD;
&#xD;
        2. During a 3-month period, use continuous quality improvement methods to decrease the time&#xD;
           for completion of PrEP eligibility screening to an interval that is acceptable to ED&#xD;
           patients and providers.&#xD;
&#xD;
      Aim 2: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial:&#xD;
&#xD;
      Identify 40 PrEP eligible patients over a 12-month period who are interested in initiating&#xD;
      PrEP in the ED. These patients will be offered immediate PrEP (iPrEP) initiation in the ED&#xD;
      with facilitated linkage to comprehensive out-patient care.&#xD;
&#xD;
        1. Evaluate the impact of a PrEP &quot;starter pack&quot; on patients agreeing to iPrEP. The primary&#xD;
           outcome is engagement in care at 30-days post PrEP initiation visit. Secondary outcomes&#xD;
           include retention in care, STI diagnosis, risk behavior and PrEP adherence.&#xD;
&#xD;
        2. Collect data on recruitment and attrition rates, as well as means and standard&#xD;
           deviations for key measures that will be needed to plan a definitive trial of&#xD;
           ED-initiated PrEP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2020</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to completion of ED PrEP screening (Implementation Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Engagement in care (Implementation Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEPPED Satisfaction and Acceptability Survey (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The VSQ-9 is a visit-specific satisfaction instrument (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CDC Sexual Behavior Questions (CSBQ) (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of new STI diagnoses (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>Number of new STI diagnosis at 30-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of new HIV Infection (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>Number of new HIV diagnosis at 30-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visit Rating Questionnaire (VSQ9) (RCT Component)</measure>
    <time_frame>30 days post-ED visit</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>PrEP</condition>
  <arm_group>
    <arm_group_label>Immediate PreP initiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP &quot;starter pack&quot; with facilitated linkage to care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Out-patient care for PrEP initiation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PrEP screening program with referral to out-patient care for PrEP initiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PreP Screening Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1: Targeted ED-based patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrEP screening program</intervention_name>
    <description>ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool</description>
    <arm_group_label>Immediate PreP initiation</arm_group_label>
    <arm_group_label>Out-patient care for PrEP initiation</arm_group_label>
    <arm_group_label>PreP Screening Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrEP starter pack</intervention_name>
    <description>emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil</description>
    <arm_group_label>Immediate PreP initiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        PrEP screen group:&#xD;
&#xD;
          -  Patients 18 years of age and above&#xD;
&#xD;
          -  Medically stable as determined by their provider&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Willing and able to consent to study participation.&#xD;
&#xD;
          -  Not requiring hospital admission for ongoing care.&#xD;
&#xD;
        iPrep group:&#xD;
&#xD;
          -  ED patients 18 years of age and above&#xD;
&#xD;
          -  HIV negative determined by 4th generation rapid testing with no evidence of acute HIV&#xD;
             infection as determined by their ED provider&#xD;
&#xD;
          -  Medically stable as determined by their primary provider&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Able to consent to participation&#xD;
&#xD;
          -  Contact information available for linkage&#xD;
&#xD;
          -  Not requiring hospital admission for ongoing care.&#xD;
&#xD;
          -  Eligible for PrEP based on CDC risk behavior and clinical criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        PrEP screen group:&#xD;
&#xD;
          -  ED patients younger than 18 years of age&#xD;
&#xD;
          -  Medically or psychiatrically unstable as determined by the ED provider&#xD;
&#xD;
          -  Unable to speak or understand English&#xD;
&#xD;
          -  Unable to provide consent for study participation.&#xD;
&#xD;
          -  Being admitted to the hospital for ongoing care&#xD;
&#xD;
        iPrEP group:&#xD;
&#xD;
          -  ED patients younger than 18 years of age&#xD;
&#xD;
          -  Known HIV positive or positive rapid HIV test in ED&#xD;
&#xD;
          -  Medically or psychiatrically unstable as determined by the ED provider&#xD;
&#xD;
          -  Unable to speak or understand English&#xD;
&#xD;
          -  Unable to provide consent for study participation&#xD;
&#xD;
          -  No means of re-contact upon ED discharge&#xD;
&#xD;
          -  No behavioral risk factors indicating need for PrEP&#xD;
&#xD;
          -  Medical contraindications to PrEP&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ethan Cowan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Ethan Cowan</investigator_full_name>
    <investigator_title>Director of Research and Community Engagement</investigator_title>
  </responsible_party>
  <keyword>Feasibility</keyword>
  <keyword>Implementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429971
org study id: GCO 19-2596
nct id: NCT04429971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
primary purpose: Screening
masking: None (Open Label)
measure: Time to completion of ED PrEP screening (Implementation Component)
time frame: 30 days post-ED visit
description: 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.
measure: Engagement in care (Implementation Component)
time frame: 30 days post-ED visit
description: 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.
measure: PrEPPED Satisfaction and Acceptability Survey (RCT Component)
time frame: 30 days post-ED visit
description: 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.
measure: The VSQ-9 is a visit-specific satisfaction instrument (RCT Component)
time frame: 30 days post-ED visit
description: 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.
measure: CDC Sexual Behavior Questions (CSBQ) (RCT Component)
time frame: 30 days post-ED visit
description: 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.
measure: Number of new STI diagnoses (RCT Component)
time frame: 30 days post-ED visit
description: Number of new STI diagnosis at 30-days
measure: Number of new HIV Infection (RCT Component)
time frame: 30 days post-ED visit
description: Number of new HIV diagnosis at 30-days
measure: Visit Rating Questionnaire (VSQ9) (RCT Component)
time frame: 30 days post-ED visit
description: 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
arm group label: Immediate PreP initiation
arm group type: Experimental
description: PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.
arm group label: Out-patient care for PrEP initiation
arm group type: Active Comparator
description: PrEP screening program with referral to out-patient care for PrEP initiation
arm group label: PreP Screening Program
arm group type: Experimental
description: Part 1: Targeted ED-based patients
intervention type: Other
intervention name: PrEP screening program
description: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
arm group label: Immediate PreP initiation
arm group label: Out-patient care for PrEP initiation
arm group label: PreP Screening Program
intervention type: Other
intervention name: PrEP starter pack
description: emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil
arm group label: Immediate PreP initiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ethan Cowan, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Ethan Cowan
investigator title: Director of Research and Community Engagement
mesh term: Emergencies
sharing ipd: No