xml: <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/NCT06003192</url>
    </required_header>
    <id_info>
      <org_study_id>1R01HD110321-01A1</org_study_id>
      <nct_id>NCT06003192</nct_id>
    </id_info>
    <brief_title>Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention</brief_title>
    <acronym>S2P</acronym>
    <official_title>Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital Medical Center, Cincinnati</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital Medical Center, Cincinnati</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this interrupted time series quasi-experimental design study is to implement&#xD;
        universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old&#xD;
        adolescents visiting the pediatric emergency department (ED). The main question[s] it aims to&#xD;
        answer are:&#xD;
  &#xD;
          1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV&#xD;
             screening across pediatric EDs after implementing an adapted version of a tablet-based&#xD;
             screening process?&#xD;
  &#xD;
          2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care&#xD;
             using a novel, digital health platform? Participants will&#xD;
  &#xD;
               1. Complete the previously developed and validated computerized sexual health screen&#xD;
                  (cSHS) containing questions regarding their personal sexual health history&#xD;
  &#xD;
               2. Have the opportunity to opt-out of clinician-ordered HIV testing&#xD;
  &#xD;
               3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll&#xD;
                  in the digital health PrEP linkage platform and followed for 3 months after&#xD;
                  enrollment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening&#xD;
        process, the investigators will adapt, refine, and test this process with the aim of&#xD;
        increasing universally offered, opt-out HIV screening in the pediatric ED through electronic&#xD;
        integration of patient reported data for provision of clinical decision support for HIV&#xD;
        screening and identification of PrEP candidacy. The investigators will then use mHealth to&#xD;
        link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this&#xD;
        previously implemented multi-center, ED-based, screening study with a goal of increasing&#xD;
        universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link&#xD;
        at-risk adolescents to PrEP services and preventive care. This will be accomplished through a&#xD;
        network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or&#xD;
        PECARN). This research will contribute to the evidence base for creating clinically effective&#xD;
        and sustainable HIV screening programs that can be successfully implemented into the clinical&#xD;
        workflow of the ED. It will also improve identification and linkage to PrEP care for at risk&#xD;
        adolescents using mHealth strategies by first identifying adolescents and young adults (AYA)&#xD;
        who are PrEP candidates based on their responses to a computerized sexual health screen&#xD;
        (cSHS) and subsequently (1) providing clinical decision support to providers via the&#xD;
        electronic health record and (2) direct text messaging from the cSHS to PrEP candidates&#xD;
        providing educational content and connecting youth to a PrEP navigator. This intervention&#xD;
        will rely on an innovative approach that electronically integrates patient-reported data to&#xD;
        guide clinical decision support.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2024</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>HIV testing rates per 1000 eligible patients during each month</measure>
      <time_frame>30 months</time_frame>
      <description>We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HIV infection rates per 1000 eligible patients during each month</measure>
      <time_frame>30 months</time_frame>
      <description>We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Linkage of PrEP</measure>
      <time_frame>30 months</time_frame>
      <description>The number of PrEP eligible youth who are enrolled in the mHealth platform and complete a followup appointment in their comprehensive PrEP care medical home within 1 month of the ED visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of PrEP eligible and interest in starting PrEP</measure>
      <time_frame>30 months</time_frame>
      <description>The proportion of patients who are identified as PrEP eligible and who endorse interest in starting PrEP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographics associated with PrEP eligibility</measure>
      <time_frame>30 months</time_frame>
      <description>Sociodemographic and visit characteristics associated with PrEP eligibility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographics associated with PrEP linkage to care</measure>
      <time_frame>30 months</time_frame>
      <description>Sociodemographic and visit characteristics associated with completion of PrEP care visit within 1 month of study enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographics associated with HIV screening acceptance</measure>
      <time_frame>30 months</time_frame>
      <description>Sociodemographic and visit characteristics associated with patient HIV screening acceptance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV positivity rates in different sexual risk strata</measure>
      <time_frame>30 months</time_frame>
      <description>Comparison of HIV positivity rates between patients in the different sexual risk strata (determined by patient entered cSHS)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">63000</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Universal Opt-out HIV Screening</arm_group_label>
      <description>The intervention is offering universal opt-out HIV screening to all adolescents 15 to 21 years of age that are seeking care in the emergency department.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Universal Opt-out HIV Screening</intervention_name>
      <description>Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.</description>
      <arm_group_label>Universal Opt-out HIV Screening</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          15 to 21 year old adolescents who are visiting the emergency department.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients 15-21 years of age visiting a pediatric emergency department.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to understand English&#xD;
  &#xD;
            -  Critically ill&#xD;
  &#xD;
            -  Cognitively impaired&#xD;
  &#xD;
            -  Altered mental status&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jennifer L Reed, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Monika Goyal, MD, MSCE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's National Research Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nadia Dowshen, MD, MSHP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Hospital of Philadelphia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tricia Cobb, MS</last_name>
      <phone>513-636-7966</phone>
      <email>patricia.cobb@cchmc.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kristin Stukus, MD</last_name>
        <phone>614-722-4385</phone>
        <email>Kristin.Stukus@nationwidechildrens.org</email>
      </contact>
      <contact_backup>
        <last_name>Annie Truelove</last_name>
        <phone>614-355-5791</phone>
        <email>annie.truelove@nationwidechildrens.org</email>
      </contact_backup>
      <investigator>
        <last_name>Kristin Stukus, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Megan Brundrett, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Children's Hospital of Philadelphia</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Cynthia Mollen, MD, MSCE</last_name>
        <phone>215-590-4410</phone>
        <email>MOLLENC@chop.edu</email>
      </contact>
      <contact_backup>
        <last_name>Joe Zorc, MD, MSCE</last_name>
        <phone>215-590-4410</phone>
        <email>ZORC@chop.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Cynthia Mollen, MD, MSCE</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marne Castillo, MEd, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sarah Wood, MD, MSCE</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Utah</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84112</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Charlie Casper, PhD</last_name>
        <phone>801-581-6410</phone>
        <email>Charlie.Casper@hsc.utah.edu</email>
      </contact>
      <contact_backup>
        <last_name>Melissa Laws, BSN</last_name>
        <phone>8015816410</phone>
        <email>Melissa.Laws@hsc.utah.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Children's Wisconsin</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michelle Pickett, MD, MS</last_name>
        <phone>414-460-0276</phone>
        <email>mpickett@mcw.edu</email>
      </contact>
      <contact_backup>
        <last_name>Danny Thomas, MD</last_name>
        <phone>414-266-2625</phone>
        <email>dthomas@mcw.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Michelle Pickett, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Claudia Vicetti, MD, MS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HIV</keyword>
    <keyword>adolescents</keyword>
    <keyword>emergency department</keyword>
    <keyword>mHealth</keyword>
    <keyword>preventive care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003192
  org study id: 1R01HD110321-01A1
  nct id: NCT06003192
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interrupted time series quasi-experimental design study is to implement
        universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old
        adolescents visiting the pediatric emergency department (ED). The main question[s] it aims to
        answer are:
  
          1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV
             screening across pediatric EDs after implementing an adapted version of a tablet-based
             screening process?
  
          2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care
             using a novel, digital health platform? Participants will
  
               1. Complete the previously developed and validated computerized sexual health screen
                  (cSHS) containing questions regarding their personal sexual health history
  
               2. Have the opportunity to opt-out of clinician-ordered HIV testing
  
               3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll
                  in the digital health PrEP linkage platform and followed for 3 months after
                  enrollment.
  Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening
        process, the investigators will adapt, refine, and test this process with the aim of
        increasing universally offered, opt-out HIV screening in the pediatric ED through electronic
        integration of patient reported data for provision of clinical decision support for HIV
        screening and identification of PrEP candidacy. The investigators will then use mHealth to
        link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this
        previously implemented multi-center, ED-based, screening study with a goal of increasing
        universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link
        at-risk adolescents to PrEP services and preventive care. This will be accomplished through a
        network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or
        PECARN). This research will contribute to the evidence base for creating clinically effective
        and sustainable HIV screening programs that can be successfully implemented into the clinical
        workflow of the ED. It will also improve identification and linkage to PrEP care for at risk
        adolescents using mHealth strategies by first identifying adolescents and young adults (AYA)
        who are PrEP candidates based on their responses to a computerized sexual health screen
        (cSHS) and subsequently (1) providing clinical decision support to providers via the
        electronic health record and (2) direct text messaging from the cSHS to PrEP candidates
        providing educational content and connecting youth to a PrEP navigator. This intervention
        will rely on an innovative approach that electronically integrates patient-reported data to
        guide clinical decision support.
  observational model: Cohort
  time perspective: Prospective
  measure: HIV testing rates per 1000 eligible patients during each month
  time frame: 30 months
  description: We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy.
  measure: HIV infection rates per 1000 eligible patients during each month
  time frame: 30 months
  description: We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy
  measure: Linkage of PrEP
  time frame: 30 months
  description: The number of PrEP eligible youth who are enrolled in the mHealth platform and complete a followup appointment in their comprehensive PrEP care medical home within 1 month of the ED visit.
  measure: Identification of PrEP eligible and interest in starting PrEP
  time frame: 30 months
  description: The proportion of patients who are identified as PrEP eligible and who endorse interest in starting PrEP
  measure: Demographics associated with PrEP eligibility
  time frame: 30 months
  description: Sociodemographic and visit characteristics associated with PrEP eligibility.
  measure: Demographics associated with PrEP linkage to care
  time frame: 30 months
  description: Sociodemographic and visit characteristics associated with completion of PrEP care visit within 1 month of study enrollment.
  measure: Demographics associated with HIV screening acceptance
  time frame: 30 months
  description: Sociodemographic and visit characteristics associated with patient HIV screening acceptance
  measure: HIV positivity rates in different sexual risk strata
  time frame: 30 months
  description: Comparison of HIV positivity rates between patients in the different sexual risk strata (determined by patient entered cSHS)
  arm group label: Universal Opt-out HIV Screening
  description: The intervention is offering universal opt-out HIV screening to all adolescents 15 to 21 years of age that are seeking care in the emergency department.
  intervention type: Other
  intervention name: Universal Opt-out HIV Screening
  description: Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.
  arm group label: Universal Opt-out HIV Screening
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 21 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jennifer L Reed, MD, MS
  role: Principal Investigator
  affiliation: Children's Hospital Medical Center, Cincinnati
  last name: Monika Goyal, MD, MSCE
  role: Principal Investigator
  affiliation: Children's National Research Institute
  last name: Nadia Dowshen, MD, MSHP
  role: Principal Investigator
  affiliation: Children's Hospital of Philadelphia
  last name: Tricia Cobb, MS
  phone: 513-636-7966
  email: patricia.cobb@cchmc.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: HIV Infections
  sharing ipd: No