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/NCT06014177</url>
    </required_header>
    <id_info>
      <org_study_id>AAAU7485</org_study_id>
      <secondary_id>5R21AI168958</secondary_id>
      <nct_id>NCT06014177</nct_id>
    </id_info>
    <brief_title>A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study</brief_title>
    <acronym>STIckER</acronym>
    <official_title>A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Columbia University</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>
        This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using&#xD;
        the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually&#xD;
        active young Emergency Department (ED) patients over six months in a pediatric and adult ED&#xD;
        setting. The primary goal is to determine if sexually active young individuals who use&#xD;
        STIckER are more likely to undergo STI testing. By developing an effective automated digital&#xD;
        tool to increase STI testing, the investigators aim to improve evidence-based sexual health&#xD;
        education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Improving sexually transmitted infection (STI) screening is vital to combat the STI epidemic,&#xD;
        especially among adolescents and young adults (AYA) aged 15-24 years in the United States.&#xD;
        Inadequate testing for STIs in different body areas contributes to disease transmission.&#xD;
        Emergency Departments (EDs) treat a significant number of young individuals, many of whom&#xD;
        come from economically disadvantaged backgrounds and minority communities. Previous research&#xD;
        has shown inconsistent use of contraception in this population, and despite the willingness&#xD;
        of ED providers to support sexual health interventions, time and resource limitations present&#xD;
        implementation challenges. To address this issue, the investigators propose developing&#xD;
        STIckER (STI ChecK in the ER), a digital patient decision aid for STI testing in the ED that&#xD;
        promotes shared decision-making. STIckER involves three steps: (1) patients complete a&#xD;
        nonjudgmental sexual health screening assessment by scanning a quick-response (QR) code, (2)&#xD;
        educational modules facilitate shared decision-making (SDM) by connecting personalized STI&#xD;
        risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital&#xD;
        infographic aids the patient-provider discussion on STI testing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ED STI Testing Rate</measure>
      <time_frame>Day 0</time_frame>
      <description>Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Extragenital STI testing Rate</measure>
      <time_frame>Day 0</time_frame>
      <description>Percent of individuals with any gonorrhea or chlamydia extra-genital (pharyngeal or rectal) test performed in the ED on the day of their STIckER visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Genitourinary STI testing Rate</measure>
      <time_frame>Day 0</time_frame>
      <description>Percent of individuals with any gonorrhea or chlamydia genitourinary test performed in the ED on the day of their STIckER visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>STI Positivity Rate</measure>
      <time_frame>Day 0</time_frame>
      <description>Percent of individuals testing positive for gonorrhea or chlamydia at any site.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention Measure (AIM) Score</measure>
      <time_frame>At completion of all patient visits (within 6 months of enrollment)</time_frame>
      <description>Acceptability assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Appropriateness Measure (IAM) Score</measure>
      <time_frame>At completion of all patient visits (within 6 months of enrollment)</time_frame>
      <description>Appropriateness assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of Intervention Measure (FIM) Score</measure>
      <time_frame>At completion of all patient visits (within 6 months of enrollment)</time_frame>
      <description>Feasibility assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>STI</condition>
    <condition>Sexually Transmitted Infection (STI)</condition>
    <condition>Sexually Transmitted Disease (STD)</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>After enrollment but before the start of their clinical visit, participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, &quot;If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor.&quot;&#xD;
  At the end of the visit, the participant will complete the &quot;Patient Control Exit Survey&quot; while the provider will complete the &quot;Provider Control Exit Survey&quot;.&#xD;
  These participants will not receive STIckER training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STIckER</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing.&#xD;
  At the end of the visit, the participant will complete the &quot;Patient Intervention Exit Survey&quot; while the provider will complete the &quot;Provider Intervention Exit Survey.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STIckER</intervention_name>
      <description>STIckER is an interactive and personalized intervention based on the principles of SDM that has been designed with input from the AYA ED patients and providers. STIckER guides AYA patients through a series of steps, beginning with &quot;scanning your STIckER.&quot; Participants complete risk assessments, SDM modules, and conclude with an anonymous final digital infographic that informs an SDM conversation with the medical provider. This decision aid seamlessly integrates into the ED workflow, recommending appropriate STI testing for high-risk individuals and using SDM concepts for those at intermediate risk.</description>
      <arm_group_label>STIckER</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>After enrollment but before the start of their clinical visit, AYA participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, &quot;If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor.&quot;</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  AYA aged 14-24 years&#xD;
  &#xD;
            -  Sexually active within the past 6 months (per self-report)&#xD;
  &#xD;
            -  Ability to speak English&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Severe illness&#xD;
  &#xD;
            -  Cognitive impairment&#xD;
  &#xD;
            -  Inability to speak English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jason Zucker, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Columbia University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lauren Chernick</last_name>
      <role>Principal Investigator</role>
      <affiliation>Columbia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jason Zucker, MD</last_name>
      <phone>212-305-7494</phone>
      <email>jz2700@cumc.columbia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lauren Chernick, MD</last_name>
      <email>lc2243@cumc.columbia.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of New York (CHONY)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lauren Chernick, MD</last_name>
        <email>lc2243@cumc.columbia.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lauren Chernick, MD</last_name>
        <email>lc2243@cumc.columbia.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Columbia University</investigator_affiliation>
      <investigator_full_name>Jason E. Zucker</investigator_full_name>
      <investigator_title>Assistant Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>Gonorrhea</keyword>
    <keyword>Chlamydia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
      <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>
  
  
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/NCT06014177
  org study id: AAAU7485
  secondary id: 5R21AI168958
  nct id: NCT06014177
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using
        the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually
        active young Emergency Department (ED) patients over six months in a pediatric and adult ED
        setting. The primary goal is to determine if sexually active young individuals who use
        STIckER are more likely to undergo STI testing. By developing an effective automated digital
        tool to increase STI testing, the investigators aim to improve evidence-based sexual health
        education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.
  Improving sexually transmitted infection (STI) screening is vital to combat the STI epidemic,
        especially among adolescents and young adults (AYA) aged 15-24 years in the United States.
        Inadequate testing for STIs in different body areas contributes to disease transmission.
        Emergency Departments (EDs) treat a significant number of young individuals, many of whom
        come from economically disadvantaged backgrounds and minority communities. Previous research
        has shown inconsistent use of contraception in this population, and despite the willingness
        of ED providers to support sexual health interventions, time and resource limitations present
        implementation challenges. To address this issue, the investigators propose developing
        STIckER (STI ChecK in the ER), a digital patient decision aid for STI testing in the ED that
        promotes shared decision-making. STIckER involves three steps: (1) patients complete a
        nonjudgmental sexual health screening assessment by scanning a quick-response (QR) code, (2)
        educational modules facilitate shared decision-making (SDM) by connecting personalized STI
        risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital
        infographic aids the patient-provider discussion on STI testing.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.
  primary purpose: Other
  masking: None (Open Label)
  measure: ED STI Testing Rate
  time frame: Day 0
  description: Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.
  measure: Extragenital STI testing Rate
  time frame: Day 0
  description: Percent of individuals with any gonorrhea or chlamydia extra-genital (pharyngeal or rectal) test performed in the ED on the day of their STIckER visit.
  measure: Genitourinary STI testing Rate
  time frame: Day 0
  description: Percent of individuals with any gonorrhea or chlamydia genitourinary test performed in the ED on the day of their STIckER visit.
  measure: STI Positivity Rate
  time frame: Day 0
  description: Percent of individuals testing positive for gonorrhea or chlamydia at any site.
  measure: Acceptability of Intervention Measure (AIM) Score
  time frame: At completion of all patient visits (within 6 months of enrollment)
  description: Acceptability assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.
  measure: Intervention Appropriateness Measure (IAM) Score
  time frame: At completion of all patient visits (within 6 months of enrollment)
  description: Appropriateness assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.
  measure: Feasibility of Intervention Measure (FIM) Score
  time frame: At completion of all patient visits (within 6 months of enrollment)
  description: Feasibility assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.
  arm group label: Control
  arm group type: Other
  description: After enrollment but before the start of their clinical visit, participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, "If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor."
  At the end of the visit, the participant will complete the "Patient Control Exit Survey" while the provider will complete the "Provider Control Exit Survey".
  These participants will not receive STIckER training.
  arm group label: STIckER
  arm group type: Experimental
  description: After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing.
  At the end of the visit, the participant will complete the "Patient Intervention Exit Survey" while the provider will complete the "Provider Intervention Exit Survey.
  intervention type: Behavioral
  intervention name: STIckER
  description: STIckER is an interactive and personalized intervention based on the principles of SDM that has been designed with input from the AYA ED patients and providers. STIckER guides AYA patients through a series of steps, beginning with "scanning your STIckER." Participants complete risk assessments, SDM modules, and conclude with an anonymous final digital infographic that informs an SDM conversation with the medical provider. This decision aid seamlessly integrates into the ED workflow, recommending appropriate STI testing for high-risk individuals and using SDM concepts for those at intermediate risk.
  arm group label: STIckER
  intervention type: Other
  intervention name: Control
  description: After enrollment but before the start of their clinical visit, AYA participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, "If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor."
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jason Zucker, MD
  role: Principal Investigator
  affiliation: Columbia University
  last name: Lauren Chernick
  role: Principal Investigator
  affiliation: Columbia University
  last name: Jason Zucker, MD
  phone: 212-305-7494
  email: jz2700@cumc.columbia.edu
  last name: Lauren Chernick, MD
  email: lc2243@cumc.columbia.edu
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Columbia University
  investigator full name: Jason E. Zucker
  investigator title: Assistant Professor of Medicine
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Sexually Transmitted Diseases
  mesh term: Emergencies
  sharing ipd: No