<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/NCT04460703</url>
  </required_header>
  <id_info>
    <org_study_id>2000027983</org_study_id>
    <nct_id>NCT04460703</nct_id>
  </id_info>
  <brief_title>COVID-19 Vaccine Messaging, Part 1</brief_title>
  <official_title>Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</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>
      This study tests different messages about vaccinating against COVID-19 once the vaccine&#xD;
      becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one&#xD;
      baseline arm. We will compare the reported willingness to get a COVID-19 vaccine at 3 and 6&#xD;
      months of it becoming available between the 10 intervention arms to the 2 control arms.&#xD;
&#xD;
      Study participants are recruited online by Lucid, which matches census based sampling in&#xD;
      online recruitment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">July 8, 2020</completion_date>
  <primary_completion_date type="Actual">July 8, 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>
    <intervention_model_description>In this study, 2/15 of participants will be assigned to a control message (bird feeding passage), 3/15 of sample to a baseline vaccine message, and 1/15 to each of the 10 other treatment arms.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intention to get COVID-19 vaccine</measure>
    <time_frame>Immediately after intervention, in the same survey in which the intervention message is provided</time_frame>
    <description>This is a self reported measure, immediately after the intervention message, of the likelihood of getting a COVID-19 vaccination within 3 months and then 6 months of it becoming available. During analysis, responses among those assigned to different intervention messages will be compared to those in the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaccine confidence scale</measure>
    <time_frame>Immediately after intervention, in the same survey in which the intervention message is provided</time_frame>
    <description>This is a validated scale. This scale will be used to assess the impact of the messages on vaccine confidence. (Outcome assessed only for the half of the sample that answers these items post-treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persuade others item</measure>
    <time_frame>Immediately after intervention, in the same survey in which the intervention message is provided</time_frame>
    <description>This is a measure of a willingness to persuade others to take the COVID-19 vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of those who have not been vaccinated</measure>
    <time_frame>Immediately after intervention, in the same survey in which the intervention message is provided</time_frame>
    <description>This is a measure of a comfort with an unvaccinated individual visiting an elderly friend after a vaccine becomes available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social judgment of those who do not vaccinate</measure>
    <time_frame>Immediately after intervention, in the same survey in which the intervention message is provided</time_frame>
    <description>This is a scale composed of 4 items measuring the trustworthiness, selfishness, likeableness, and competence of those who choose not to get vaccinated after a vaccine becomes available</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">4000</enrollment>
  <condition>Vaccination</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control message about birdfeeding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline message</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Personal freedom</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Economic freedom</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social benefit, self-interest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social benefit, community interest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Economic benefit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social pressure- guilt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social pressure- embarrassment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social pressure- anger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trust in science</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not bravery arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental message arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control message</intervention_name>
    <description>2/15 of the sample will be assigned to the pure control group, which is a passage on the costs and benefits of bird feeding.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline message</intervention_name>
    <description>3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.</description>
    <arm_group_label>Baseline message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personal freedom message</intervention_name>
    <description>1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting people's personal freedom and by working together to get enough people vaccinated society can preserve its personal freedom.</description>
    <arm_group_label>Personal freedom</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Economic freedom message</intervention_name>
    <description>1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting peoples's economic freedom and by working together to get enough people vaccinated society can preserve its economic freedom.</description>
    <arm_group_label>Economic freedom</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-interest message</intervention_name>
    <description>1/15 of the sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to one's health, even if one is young and healthy. Getting vaccinated against COVID-19 is the best way to prevent oneself from getting sick.</description>
    <arm_group_label>Social benefit, self-interest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community interest message</intervention_name>
    <description>1/15 of the sample will be assigned to this intervention, which is a message about the dangers of COVID-19 to the health of loved ones. The more people who get vaccinated against COVID-19, the lower the risk that one's loved ones will get sick. Society must work together and all get vaccinated.</description>
    <arm_group_label>Social benefit, community interest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Economic benefit message</intervention_name>
    <description>1/15 of the sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on the economy and the only way to strengthen the economy is to work together to get enough people vaccinated.</description>
    <arm_group_label>Economic benefit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guilt message</intervention_name>
    <description>1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and society must work together to get enough people vaccinated. Then it asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease.</description>
    <arm_group_label>Social pressure- guilt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Embarrassment message</intervention_name>
    <description>1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the embarrassment they will feel if they don't get vaccinated and spread the disease.</description>
    <arm_group_label>Social pressure- embarrassment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anger message</intervention_name>
    <description>1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the anger they will feel if they don't get vaccinated and spread the disease.</description>
    <arm_group_label>Social pressure- anger</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trust in science message</intervention_name>
    <description>1/15 of the sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting one's community. Vaccination is backed by science. If one doesn't get vaccinated that means that one doesn't understand how infections are spread or who ignores science.</description>
    <arm_group_label>Trust in science</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not bravery message</intervention_name>
    <description>1/15 of the sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. Those who choose not to get vaccinated against COVID-19 are not brave.</description>
    <arm_group_label>Not bravery arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  US resident&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Non-US resident&#xD;
&#xD;
          -  Do not consent&#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>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>James EK, Bokemper SE, Gerber AS, Omer SB, Huber GA. Persuasive messaging to increase COVID-19 vaccine uptake intentions. Vaccine. 2021 Dec 3;39(49):7158-7165. doi: 10.1016/j.vaccine.2021.10.039. Epub 2021 Oct 22.</citation>
    <PMID>34774363</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>messaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized data and analysis code will be posted in a public replication archive after publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After publication</ipd_time_frame>
    <ipd_access_criteria>Anonymized data and analysis code will be posted in a public replication archive</ipd_access_criteria>
  </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/NCT04460703
org study id: 2000027983
nct id: NCT04460703
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tests different messages about vaccinating against COVID-19 once the vaccine
      becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one
      baseline arm. We will compare the reported willingness to get a COVID-19 vaccine at 3 and 6
      months of it becoming available between the 10 intervention arms to the 2 control arms.

      Study participants are recruited online by Lucid, which matches census based sampling in
      online recruitment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, 2/15 of participants will be assigned to a control message (bird feeding passage), 3/15 of sample to a baseline vaccine message, and 1/15 to each of the 10 other treatment arms.
primary purpose: Other
masking: None (Open Label)
measure: Intention to get COVID-19 vaccine
time frame: Immediately after intervention, in the same survey in which the intervention message is provided
description: This is a self reported measure, immediately after the intervention message, of the likelihood of getting a COVID-19 vaccination within 3 months and then 6 months of it becoming available. During analysis, responses among those assigned to different intervention messages will be compared to those in the control group.
measure: Vaccine confidence scale
time frame: Immediately after intervention, in the same survey in which the intervention message is provided
description: This is a validated scale. This scale will be used to assess the impact of the messages on vaccine confidence. (Outcome assessed only for the half of the sample that answers these items post-treatment)
measure: Persuade others item
time frame: Immediately after intervention, in the same survey in which the intervention message is provided
description: This is a measure of a willingness to persuade others to take the COVID-19 vaccine.
measure: Fear of those who have not been vaccinated
time frame: Immediately after intervention, in the same survey in which the intervention message is provided
description: This is a measure of a comfort with an unvaccinated individual visiting an elderly friend after a vaccine becomes available
measure: Social judgment of those who do not vaccinate
time frame: Immediately after intervention, in the same survey in which the intervention message is provided
description: This is a scale composed of 4 items measuring the trustworthiness, selfishness, likeableness, and competence of those who choose not to get vaccinated after a vaccine becomes available
arm group label: Control
arm group type: Sham Comparator
description: Control message about birdfeeding
arm group label: Baseline message
arm group type: Active Comparator
description: These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language.
arm group label: Personal freedom
arm group type: Experimental
description: Experimental message arm.
arm group label: Economic freedom
arm group type: Experimental
description: Experimental message arm.
arm group label: Social benefit, self-interest
arm group type: Experimental
description: Experimental message arm.
arm group label: Social benefit, community interest
arm group type: Experimental
description: Experimental message arm.
arm group label: Economic benefit
arm group type: Experimental
description: Experimental message arm.
arm group label: Social pressure- guilt
arm group type: Experimental
description: Experimental message arm.
arm group label: Social pressure- embarrassment
arm group type: Experimental
description: Experimental message arm.
arm group label: Social pressure- anger
arm group type: Experimental
description: Experimental message arm.
arm group label: Trust in science
arm group type: Experimental
description: Experimental message arm.
arm group label: Not bravery arm
arm group type: Experimental
description: Experimental message arm.
intervention type: Other
intervention name: Control message
description: 2/15 of the sample will be assigned to the pure control group, which is a passage on the costs and benefits of bird feeding.
arm group label: Control
intervention type: Other
intervention name: Baseline message
description: 3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.
arm group label: Baseline message
intervention type: Other
intervention name: Personal freedom message
description: 1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting people's personal freedom and by working together to get enough people vaccinated society can preserve its personal freedom.
arm group label: Personal freedom
intervention type: Other
intervention name: Economic freedom message
description: 1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting peoples's economic freedom and by working together to get enough people vaccinated society can preserve its economic freedom.
arm group label: Economic freedom
intervention type: Other
intervention name: Self-interest message
description: 1/15 of the sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to one's health, even if one is young and healthy. Getting vaccinated against COVID-19 is the best way to prevent oneself from getting sick.
arm group label: Social benefit, self-interest
intervention type: Other
intervention name: Community interest message
description: 1/15 of the sample will be assigned to this intervention, which is a message about the dangers of COVID-19 to the health of loved ones. The more people who get vaccinated against COVID-19, the lower the risk that one's loved ones will get sick. Society must work together and all get vaccinated.
arm group label: Social benefit, community interest
intervention type: Other
intervention name: Economic benefit message
description: 1/15 of the sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on the economy and the only way to strengthen the economy is to work together to get enough people vaccinated.
arm group label: Economic benefit
intervention type: Other
intervention name: Guilt message
description: 1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and society must work together to get enough people vaccinated. Then it asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease.
arm group label: Social pressure- guilt
intervention type: Other
intervention name: Embarrassment message
description: 1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the embarrassment they will feel if they don't get vaccinated and spread the disease.
arm group label: Social pressure- embarrassment
intervention type: Other
intervention name: Anger message
description: 1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the anger they will feel if they don't get vaccinated and spread the disease.
arm group label: Social pressure- anger
intervention type: Other
intervention name: Trust in science message
description: 1/15 of the sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting one's community. Vaccination is backed by science. If one doesn't get vaccinated that means that one doesn't understand how infections are spread or who ignores science.
arm group label: Trust in science
intervention type: Other
intervention name: Not bravery message
description: 1/15 of the sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. Those who choose not to get vaccinated against COVID-19 are not brave.
arm group label: Not bravery arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: James EK, Bokemper SE, Gerber AS, Omer SB, Huber GA. Persuasive messaging to increase COVID-19 vaccine uptake intentions. Vaccine. 2021 Dec 3;39(49):7158-7165. doi: 10.1016/j.vaccine.2021.10.039. Epub 2021 Oct 22.
PMID: 34774363
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: Anonymized data and analysis code will be posted in a public replication archive after publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After publication
ipd access criteria: Anonymized data and analysis code will be posted in a public replication archive