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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05085613
Other study ID # 00015120B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2021
Est. completion date March 31, 2022

Study information

Verified date July 2023
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to assess the efficacy of educational messages to correct misperceptions. People hold a number of misperceptions that are relevant to public health, including misperceptions regarding COVID vaccines. Some people incorrectly think the COVID vaccines authorized by FDA are not safe or effective. These misperceptions can reduce adherence to public health recommendations and result in continued spread of COVID. This study will test if humor and different types of framing increase the efficacy of messages to correct misperceptions about FDA's authorized coronavirus vaccine safety and effectiveness. The frames tested will include: framing the vaccine as a way to boost economic recovery and framing the vaccine as a way to increase freedom to choose how to behave. The addition of humor will also be tested. Message efficacy will be measured via improved accuracy of beliefs after being exposed to the message. In other words, participants will be asked how safe and effective FDA authorized COVID vaccines are before seeing a message, then they will see a message about why the COVID vaccines are safe and effective, and then they will again be asked how safe and effective they think the vaccines are. This study will also assess the accuracy of inferential beliefs. This will be accomplished by asking participants questions about other vaccines that either are or are not authorized by FDA. If participants have understood the messages and updated their mental models of how FDA evaluates vaccines, they should be able to infer if other vaccines are safe and effective based on their FDA authorization status. Hypotheses H1: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase their agreement with the statement that the FDA will only authorize coronavirus vaccines that are safe and effective after message exposure than participants exposed to the control condition. H2: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the FDA approved flu vaccine is safe and effective after message exposure than participants exposed to the control condition. H3. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the ResVax vaccine, which was not approved by the FDA for the treatment of RSV, is a safe and effective after message exposure than participants exposed to the control condition. H4. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase behavioral intentions to get an FDA authorized COVID vaccine after message exposure than participants exposed to the control condition.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 31, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility Inclusion Criteria: - Are 21 years of age or older. - Have not participated in the cognitive interview. - Have not yet received a COVID vaccine. - Are registered with MTurk in the United States. - Have completed >= 5,000 HIITs within the MTurk system - Have a HIIT approval rating of >= 97% - Rate their agreement with the following statement as less than or equal to 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective." Exclusion Criteria: - Are younger than 21 years of age - Participated in the cognitive interviews - Have already received a COVID vaccine. - Are not registered with MTurk in the US - Have completed < 5,000 HIITS - Have a HIIT approval rating of <97% - Rate their agreement with the following statement as greater than 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective."

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Corrective message framing and humor
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective Assessed by change in response to the question To what extent do you agree or disagree with the following statement: The FDA has only authorized COVID vaccines that are safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree." Baseline and up to 5 minutes after receiving the corrective message
Primary Accuracy of Inferential Belief That the FDA Authorized Flu Vaccine is Safe and Effective Assessed by response to the question To what extent do you agree with the following: The FDA authorized flu vaccine is safe and effective.; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree." Up to 5 minutes after receiving the corrective message
Primary Accuracy of Inferential Belief That RexVax is Safe and Effective Assessed by response to the question, The FDA recommended more testing of ResVax and did NOT authorize the vaccine because it did not prevent enough RSV infections.
To what extent do you agree with the following: ResVax is safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Up to 5 minutes after receiving the corrective message
Primary Change in Intention to Get a COVID-19 Vaccine Assessed by change in response to the statement: I plan on getting an FDA authorized coronavirus vaccine; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree." Baseline and up to 5 minutes after receiving the corrective message
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