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COVID-19 Vaccine Messaging, Part 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460703
Recruitment Status : Completed
First Posted : July 7, 2020
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE July 2, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date May 5, 2022
Actual Study Start Date  ICMJE July 3, 2020
Actual Primary Completion Date July 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2020)		 Intention to get COVID-19 vaccine [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)		 Intention to get COVID-19 vaccine [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
This is a self reported measure of the likelihood of getting a COVID-19 vaccination within 3 months and then 6 months of it becoming available.We will compare those in the control groups to the 10 different intervention messages.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2020)
  • Vaccine confidence scale [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    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)
  • Persuade others item [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    This is a measure of a willingness to persuade others to take the COVID-19 vaccine.
  • Fear of those who have not been vaccinated [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    This is a measure of a comfort with an unvaccinated individual visiting an elderly friend after a vaccine becomes available
  • Social judgment of those who do not vaccinate [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • Vaccine confidence scale [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    This is a validated scale. We will use the scale 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)
  • Persuade others item [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    This is a measure of a willingness to persuade others to take the COVID-19 vaccine.
  • Fear of those who have not been vaccinated [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    This is a measure of a comfort with an unvaccinated individual visiting an elderly friend after a vaccine becomes available
  • Social judgment of those who do not vaccinate [ Time Frame: Immediately after intervention, in the same survey in which the intervention message is provided ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Vaccine Messaging, Part 1
Official Title  ICMJE Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Vaccination
  • COVID-19
Intervention  ICMJE
  • Other: Control message
    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.
  • Other: Baseline message
    3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.
  • Other: Personal freedom message
    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.
  • Other: Economic freedom message
    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.
  • Other: Self-interest message
    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.
  • Other: Community interest message
    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.
  • Other: Economic benefit message
    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.
  • Other: Guilt message
    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.
  • Other: Embarrassment message
    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.
  • Other: Anger message
    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.
  • Other: Trust in science message
    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.
  • Other: Not bravery message
    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.
Study Arms  ICMJE
  • Sham Comparator: Control
    Control message about birdfeeding
    Intervention: Other: Control message
  • Active Comparator: Baseline message
    These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language.
    Intervention: Other: Baseline message
  • Experimental: Personal freedom
    Experimental message arm.
    Intervention: Other: Personal freedom message
  • Experimental: Economic freedom
    Experimental message arm.
    Intervention: Other: Economic freedom message
  • Experimental: Social benefit, self-interest
    Experimental message arm.
    Intervention: Other: Self-interest message
  • Experimental: Social benefit, community interest
    Experimental message arm.
    Intervention: Other: Community interest message
  • Experimental: Economic benefit
    Experimental message arm.
    Intervention: Other: Economic benefit message
  • Experimental: Social pressure- guilt
    Experimental message arm.
    Intervention: Other: Guilt message
  • Experimental: Social pressure- embarrassment
    Experimental message arm.
    Intervention: Other: Embarrassment message
  • Experimental: Social pressure- anger
    Experimental message arm.
    Intervention: Other: Anger message
  • Experimental: Trust in science
    Experimental message arm.
    Intervention: Other: Trust in science message
  • Experimental: Not bravery arm
    Experimental message arm.
    Intervention: Other: Not bravery message
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2020)		 4000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2020
Actual Primary Completion Date July 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • US resident

Exclusion Criteria:

  • Younger than 18 years of age
  • Non-US resident
  • Do not consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04460703
Other Study ID Numbers  ICMJE 2000027983
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized data and analysis code will be posted in a public replication archive after publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: After publication
Access Criteria: Anonymized data and analysis code will be posted in a public replication archive
Current Responsible Party Yale University
Original Responsible Party Gregory Huber, PhD, Yale University, Chair, Department of Political Science
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Gregory Huber, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP