<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/NCT04450537</url>
  </required_header>
  <id_info>
    <org_study_id>00000693</org_study_id>
    <secondary_id>U54DA036114</secondary_id>
    <nct_id>NCT04450537</nct_id>
  </id_info>
  <brief_title>PACE Vape Messaging Study</brief_title>
  <official_title>Effects of Anti-JUUL-type Messages on Beliefs, Perceived Harms, and Behavioral Intentions Among Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</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>
      The purpose of this study is to examine the effect of exposure to vape education messages on&#xD;
      beliefs, perceptions, norms, and behaviors related to electronic vapor product use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using content developed from the formative research phase, participants in this randomized&#xD;
      controlled trial will either be exposed to ten vape education messages or to ten messages on&#xD;
      sun safety, with all messages formatted for social media.&#xD;
&#xD;
      This study will take place over a 1-month period. Individuals who complete the screening&#xD;
      survey and are eligible to participate will be invited to complete a 10-15 minute baseline&#xD;
      survey at the start of the study. This survey will ask questions about tobacco and electronic&#xD;
      vapor product use, and beliefs about and perceptions of vape products. This survey will also&#xD;
      ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on&#xD;
      vaping and tobacco use, and peer and family influences on tobacco use. During the survey,&#xD;
      participants will be presented with and be asked to provide feedback for short health-related&#xD;
      messages.&#xD;
&#xD;
      One month after completing this survey, participants will be sent an invitation to the&#xD;
      follow-up survey. This survey will again ask about tobacco and electronic vapor product use,&#xD;
      and beliefs about and perceptions of vape products.&#xD;
&#xD;
      All study procedures will take place remotely, with surveys conducted online. At the end of&#xD;
      the first survey, participants will be eligible to receive a $10 online gift card. Upon&#xD;
      completion of the follow-up survey, participants will be eligible to receive a $15 online&#xD;
      gift card. In total, participants will be eligible to receive up to $25 for completing both&#xD;
      surveys. Those who are ineligible will not be asked to complete the baseline survey and will&#xD;
      not be compensated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nicotine/e-cigarette beliefs</measure>
    <time_frame>Assessed at 1-month follow-up</time_frame>
    <description>True/false/don't know questions about nicotine and electronic vapor/tobacco products</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vape harm perceptions</measure>
    <time_frame>Assessed at 1-month follow-up</time_frame>
    <description>Harm perception questions about use of electronic vapor/vape products</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaping-related norms</measure>
    <time_frame>Assessed at 1-month follow-up</time_frame>
    <description>Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral intentions</measure>
    <time_frame>Assessed at 1-month follow-up</time_frame>
    <description>Questions about intent to use electronic vapor/vape products in the next 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">569</enrollment>
  <condition>Vaping</condition>
  <condition>E-cigarette Use</condition>
  <condition>Electronic Cigarette Use</condition>
  <arm_group>
    <arm_group_label>Vape Messaging Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be exposed to 10 vape education messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sun Safety Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be exposed 10 sun safety messages</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vape Messaging Intervention</intervention_name>
    <description>Participants will be exposed to 10 vape education messages</description>
    <arm_group_label>Vape Messaging Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-24&#xD;
&#xD;
          -  Vermont resident&#xD;
&#xD;
          -  Access to a smartphone with internet&#xD;
&#xD;
          -  Use of one or more social media site(s) at least weekly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged 25 years or older&#xD;
&#xD;
          -  Not Vermont resident&#xD;
&#xD;
          -  No access to a smartphone with internet&#xD;
&#xD;
          -  Use of one or more social media site(s) less than weekly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea C Villanti, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.pacevt.org</url>
    <description>Study website</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Andrea Villanti</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>surveys</keyword>
  <keyword>vaping</keyword>
  <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/NCT04450537
org study id: 00000693
secondary id: U54DA036114
nct id: NCT04450537
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effect of exposure to vape education messages on
      beliefs, perceptions, norms, and behaviors related to electronic vapor product use.
Using content developed from the formative research phase, participants in this randomized
      controlled trial will either be exposed to ten vape education messages or to ten messages on
      sun safety, with all messages formatted for social media.

      This study will take place over a 1-month period. Individuals who complete the screening
      survey and are eligible to participate will be invited to complete a 10-15 minute baseline
      survey at the start of the study. This survey will ask questions about tobacco and electronic
      vapor product use, and beliefs about and perceptions of vape products. This survey will also
      ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on
      vaping and tobacco use, and peer and family influences on tobacco use. During the survey,
      participants will be presented with and be asked to provide feedback for short health-related
      messages.

      One month after completing this survey, participants will be sent an invitation to the
      follow-up survey. This survey will again ask about tobacco and electronic vapor product use,
      and beliefs about and perceptions of vape products.

      All study procedures will take place remotely, with surveys conducted online. At the end of
      the first survey, participants will be eligible to receive a $10 online gift card. Upon
      completion of the follow-up survey, participants will be eligible to receive a $15 online
      gift card. In total, participants will be eligible to receive up to $25 for completing both
      surveys. Those who are ineligible will not be asked to complete the baseline survey and will
      not be compensated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Nicotine/e-cigarette beliefs
time frame: Assessed at 1-month follow-up
description: True/false/don't know questions about nicotine and electronic vapor/tobacco products
measure: Vape harm perceptions
time frame: Assessed at 1-month follow-up
description: Harm perception questions about use of electronic vapor/vape products
measure: Vaping-related norms
time frame: Assessed at 1-month follow-up
description: Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL
measure: Behavioral intentions
time frame: Assessed at 1-month follow-up
description: Questions about intent to use electronic vapor/vape products in the next 12 months
arm group label: Vape Messaging Intervention
arm group type: Experimental
description: Participants will be exposed to 10 vape education messages
arm group label: Sun Safety Control
arm group type: No Intervention
description: Participants will be exposed 10 sun safety messages
intervention type: Behavioral
intervention name: Vape Messaging Intervention
description: Participants will be exposed to 10 vape education messages
arm group label: Vape Messaging Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea C Villanti, PhD, MPH
role: Principal Investigator
affiliation: University of Vermont
facility: 
country: United States
url: https://www.pacevt.org
description: Study website
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Andrea Villanti
investigator title: Associate Professor
sharing ipd: No