History of Changes for Study: NCT04460703

COVID-19 Vaccine Messaging Randomized Controlled Trial, Part 1

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Study Record Versions

Version	Submitted Date	Changes
1	July 6, 2020	None (earliest Version on record)
2	July 18, 2020	Recruitment Status, Study Status, Sponsor/Collaborators, Outcome Measures, Study Design, Study Identification, Contacts/Locations and Arms and Interventions
3	October 28, 2021	Study Status and References
4	April 29, 2022	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	COVIDvaccinepersuasion1
Brief Title:	COVID-19 Vaccine Messaging Randomized Controlled Trial, Part 1
Official Title:	Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
Secondary IDs:

Study Status


Record Verification:	July 2020
Overall Status:	Not yet recruiting
Study Start:	July 3, 2020
Primary Completion:	July 31, 2020 [Anticipated]
Study Completion:	July 31, 2020 [Anticipated]

First Submitted:	July 2, 2020
First Submitted that Met QC Criteria:	July 6, 2020
First Posted:	July 7, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	July 6, 2020
Last Update Posted:	July 7, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Gregory Huber, PhD
Responsible Party:	Sponsor-Investigator Investigator: Gregory Huber, PhD Official Title: Chair, Department of Political Science Affiliation: Yale University
Collaborators:	Yale University

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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:

Conditions


Conditions:	Vaccination COVID-19
Keywords:	messaging

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	We are assigning 2/15 of our sample to a control message (birdfeeding passage), 3/15 of our sample to a baseline vaccine message, and then 1/15 to each of the 10 other treatment arms.
Number of Arms:	12
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	4000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Sham Comparator: Control Control message about birdfeeding	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.
Active Comparator: Baseline message These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language.	Baseline message 3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.
Experimental: Personal freedom Experimental message arm.	Personal freedom message 1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting our personal freedom and we can ensure that by working together to get enough people vaccinated we can preserve our personal freedom.
Experimental: Economic freedom Experimental message arm.	Economic freedom message 1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting our economic freedom and we can ensure that by working together to get enough people vaccinated we can preserve our economic freedom.
Experimental: Social benefit, self-interest Experimental message arm.	Self-interest message 1/15 of our sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to your health, even if you are young and healthy. Getting vaccinated against COVID-19 is the best way to prevent yourself from getting sick.
Experimental: Social benefit, community interest Experimental message arm.	Community interest message 1/15 of our 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 your loved ones will get sick. We must work together and all get vaccinated.
Experimental: Economic benefit Experimental message arm.	Economic benefit message 1/15 of our sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on our economy and the only way to strengthen the economy is to work together to get enough people vaccinated.
Experimental: Social pressure- guilt Experimental message arm.	Guilt message 1/15 of our sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of your family and members of your community. The best way to protect them is by getting vaccinated and we 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.
Experimental: Social pressure- embarrassment Experimental message arm.	Embarrassment message 1/15 of our sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of your family and members of your community. The best way to protect them is by getting vaccinated and we must work 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.
Experimental: Social pressure- anger Experimental message arm.	Anger message 1/15 of our sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of your family and members of your community. The best way to protect them is by getting vaccinated and we must work 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.
Experimental: Trust in science Experimental message arm.	Trust in science message 1/15 of our sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting your community. Vaccination is backed by science. If you don't get vaccinated that means that you don't understand how infections are spread or who ignores about science.
Experimental: Not bravery arm Experimental message arm.	Not bravery message 1/15 of our sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. You are not brave if you choose not to get vaccinated against COVID-19.

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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)
2.	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.
3.	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
4.	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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: At least 18 years of age US resident Exclusion Criteria: Younger than 18 years of age Non-US resident Do not consent

Contacts/Locations


Locations:

IPDSharing


Plan to Share IPD:	Yes Anonymized data and analysis code will be posted in a public replication archive after publication.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code
	Time Frame: After publication
	Access Criteria: Anonymized data and analysis code will be posted in a public replication archive
	URL:

References


Links:
Available IPD/Information: