COVID-19 Vaccine Messaging, Part 1

• ClinicalTrials.gov Identifier: NCT04460703
• Recruitment Status: Completed
• First Posted: July 7, 2020
• Last Update Posted: May 5, 2022
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

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.

Condition or disease	Intervention/treatment	Phase
Vaccination; COVID-19	Other: Control message; Other: Baseline message; Other: Personal freedom message; Other: Economic freedom message; Other: Self-interest message; Other: Community interest message; Other: Economic benefit message; Other: Guilt message; Other: Embarrassment message; Other: Anger message; Other: Trust in science message; Other: Not bravery message	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4000 participants
• 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
• Official Title: Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
• Actual Study Start Date: July 3, 2020
• Actual Primary Completion Date: July 8, 2020
• Actual Study Completion Date: July 8, 2020

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Control; Control message about birdfeeding	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.
Active Comparator: Baseline message; These participants will be assigned a message about the benefits of vaccination. All other treatment arms include this baseline language.	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.
Experimental: Personal freedom; Experimental message arm.	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.
Experimental: Economic freedom; Experimental message arm.	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.
Experimental: Social benefit, self-interest; Experimental message arm.	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.
Experimental: Social benefit, community interest; Experimental message arm.	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.
Experimental: Economic benefit; Experimental message arm.	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.
Experimental: Social pressure- guilt; Experimental message arm.	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.
Experimental: Social pressure- embarrassment; Experimental message arm.	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.
Experimental: Social pressure- anger; Experimental message arm.	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.
Experimental: Trust in science; Experimental message arm.	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.
Experimental: Not bravery arm; Experimental message arm.	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.

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, 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.

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. 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)
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 Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

More Information

Publications of Results:

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04460703
• Other Study ID Numbers: 2000027983
• First Posted: July 7, 2020
• Last Update Posted: May 5, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• 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; 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

messaging

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases