NCT05085613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

October 1, 2021

Results QC Date

August 18, 2022

Last Update Submit

July 28, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

Vaccine Corrective Control

ACTIVE COMPARATOR

A message that explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how the vaccines are evaluated as safe and effective by FDA.

Behavioral: Corrective message framing and humor

Vaccine corrective with economic recovery framing

EXPERIMENTAL

The content of the control message with the addition of the text, "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." The message will also include a picture of an "open for business" sign.

Behavioral: Corrective message framing and humor

Vaccine corrective with freedom framing

EXPERIMENTAL

The content of the control message with the addition of the text, "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." The message will also include a picture of an American flag.

Behavioral: Corrective message framing and humor

Vaccine corrective with humor

EXPERIMENTAL

The content of the control message with the addition of the text, "Unfortunately, everyone getting vaccinated means leaving the house again." The message will include a meme of a cat being pulled/rescued from a window with text boxes labeling the cat as "People at home working in sweatpants" and the rescuer as "COVID Vaccines."

Behavioral: Corrective message framing and humor

Interventions

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.

Vaccine Corrective ControlVaccine corrective with economic recovery framingVaccine corrective with freedom framingVaccine corrective with humor

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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."

You may not qualify if:

  • 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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Limitations and Caveats

Limitations include the ANCOVAs being underpowered. Failure to reject the null offers limited value because there's not strong support for lack of effect. Beliefs were also measured on a continuous scales, which can detect even small effects.

Results Point of Contact

Title
Caitlin Weiger
Organization
Johns Hopkins Bloomberg School of Public Health

Study Officials

  • Meghan Moran, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Model Description: Participants will be randomized to view one of four messages. The control message explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how they are evaluated. Arm 2 additionally includes consequent framing regarding economic recovery (e.g. "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." With a picture of an "open for business" sign), arm 3 includes consequent framing regarding freedom to behave as one chooses (e.g. "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." With a picture of an American flag), and arm 4 includes humor (e.g. "Unfortunately, everyone getting vaccinated means leaving the house again.").
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 20, 2021

Study Start

October 31, 2021

Primary Completion

January 30, 2022

Study Completion

March 31, 2022

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Upon request, deidentified participant data collected during the study may be shared. Upon request, we may also share the study protocol, survey, and informed consent form. Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. Data will be made available for analyses deemed appropriate by the study PI. Proposals should be directed to mmoran22@jhu.edu. Data requestors will need to sign a data access agreement.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Starting 3 months following publication of the final article from this study, with no end date.

Locations