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Views on COVID-19 and Vaccination

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication from a physician about the COVID-19 Vaccine
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Covid-19, Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (age 18 and over) who are members of an online panel (Prolific). Members of this panel joined the panel specifically to receive invitations to participate in research surveys and similar activities.
  • Able to complete an online survey in English.

Exclusion Criteria:

• None

Sites / Locations

  • Meyers Health Care Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Message 1

Message 2

Message 3

Message 4

Message 5

Arm Description

Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation ("What do you think?")

Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation ("I recommend that you get it").

Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation ("I recommend that you get it").

Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation ("I recommend that you get it").

Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation ("I recommend that you get it").

Outcomes

Primary Outcome Measures

Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message
All participants were asked about their intent to be vaccinated against COVID-19 prior to exposure to one of the five physician messages (Response options: Yes, No, Not sure). After participants were randomly assigned to receive one of the five physician messages, reduction in COVID-19 vaccine hesitancy was assessed with the question: "Would you get vaccinated at this visit". Response options included yes, no, not sure. For participants whose initial vaccination intent was "not sure", a response of "yes" on re-assessment was defined as less hesitant. Response of "not sure" or "yes" were defined as less hesitant for participants whose initial vaccination intent was "no".

Secondary Outcome Measures

Full Information

First Posted
January 5, 2021
Last Updated
May 20, 2022
Sponsor
University of Massachusetts, Worcester
Collaborators
National Library of Medicine (NLM)
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1. Study Identification

Unique Protocol Identification Number
NCT04706403
Brief Title
Views on COVID-19 and Vaccination
Official Title
If We Build It, Will They Come? A Pilot Study to Develop and Test Messages to Maximize Uptake of Coronavirus Vaccine When Available
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Library of Medicine (NLM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to develop evidence-based messages that effectively mitigate concerns of people at risk for not being vaccinated against COVID-19, with the ultimate goal of maximizing vaccine uptake in vulnerable populations. The investigators will collect data on COVID-19 disease and vaccine knowledge, beliefs, and intent to be vaccinated from an existing online panel. Results from this data collection will be used to develop effective messages and communication strategies. The investigators will test alternate versions of messages intended to reduce vaccine hesitancy and promote vaccine uptake among vaccine-hesitant individuals. This project will ultimately result in a set of tested, evidence-derived messages about vaccination for COVID-19.
Detailed Description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly instigated a global pandemic. As of this writing, there are approximately 65 million documented cases of infection worldwide, and over 1.5 million deaths. In the United States (US), coronavirus disease 2019 (COVID-19) has disrupted the economy, overwhelmed healthcare system, led to widespread school cancellations, and caused more than 274,000 deaths since March 2020. A vaccine against COVID-19 is widely viewed as the key to controlling the pandemic and enabling a return to "normal" life. Vaccine development is proceeding at an unprecedented pace with 10 vaccines currently in phase 3 trials. Experts have projected that a safe and effective vaccine may be available by mid-2021. At the same time, a growing body of evidence indicates that a significant proportion of adults in the U.S. may not accept vaccination against COVID-19. Even more alarming, COVID-19 vaccine hesitancy (refusal or reluctance to accept a vaccine) appears to be increasing as the vaccine approval process becomes increasingly politicized. Just as efforts to develop vaccine production and delivery capacity have been undertaken in advance of having a proven effective vaccine, parallel efforts are needed to identify effective messages and communication strategies to overcome COVID-19 vaccine hesitancy. The study team recently surveyed a nationally representative sample of approximately 1,000 adults in the United States and found that only 57% intended to be vaccinated when a coronavirus vaccine becomes available. This percentage was even lower among people who identified as Black or Hispanic (39% and 43% respectively), those with a high school education or less (46%), and those in the lowest income groups (49% of those reporting a household income of $30,000 or less, compared to 72% of those reporting a household income of $100,000 or more). The investigators asked those who indicated they would not or might not get vaccinated for their reasons and found that some individuals may be willing to be vaccinated if provided specific information about the vaccine such as side effects and effectiveness. Others expressed generalized skepticism, fear, and distrust of vaccines, with some even referring to anti-vaccine conspiracy theories. These findings are consistent with an extensive body of research documenting that people often do not behave rationally and highlight the urgent need to proactively develop and test interventions to maximize vaccination rates when a coronavirus vaccine becomes available. To address this need, in the present study, the investigators aim to create and test targeted messages to address the concerns of subgroups of people at risk for not being vaccinated, with the ultimate goal of maximizing vaccine uptake when a vaccine for COVID-19 becomes available. The investigators will accomplish this by working with an existing online panel of volunteers, which will allow efficient, focused data gathering. Results of the survey will provide a nuanced, current description of how vulnerable adults perceive the coronavirus and available vaccines, which will be used as the basis for developing messages and communication strategies. Participants will be randomized to receive one of five different versions of a message from a healthcare provider regarding vaccination. Specific wording and content of these messages will vary systematically in order to address concerns of those at risk for not being vaccinated. This project will ultimately result in a set of tested, evidence-derived messages about vaccination for COVID-19. The investigators will make these messages available, together with evidence of how these influence members of vulnerable populations' understanding of vaccination, and disease risk, as well as intent to be vaccinated. The messages will be freely available for use by organizations and providers seeking to improve communication about a coronavirus vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid-19, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
756 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Message 1
Arm Type
Experimental
Arm Description
Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation ("What do you think?")
Arm Title
Message 2
Arm Type
Experimental
Arm Description
Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation ("I recommend that you get it").
Arm Title
Message 3
Arm Type
Experimental
Arm Description
Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation ("I recommend that you get it").
Arm Title
Message 4
Arm Type
Experimental
Arm Description
Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation ("I recommend that you get it").
Arm Title
Message 5
Arm Type
Experimental
Arm Description
Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation ("I recommend that you get it").
Intervention Type
Behavioral
Intervention Name(s)
Communication from a physician about the COVID-19 Vaccine
Intervention Description
Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician. The messages that participants in each group received varied slightly and systematically. Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.
Primary Outcome Measure Information:
Title
Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message
Description
All participants were asked about their intent to be vaccinated against COVID-19 prior to exposure to one of the five physician messages (Response options: Yes, No, Not sure). After participants were randomly assigned to receive one of the five physician messages, reduction in COVID-19 vaccine hesitancy was assessed with the question: "Would you get vaccinated at this visit". Response options included yes, no, not sure. For participants whose initial vaccination intent was "not sure", a response of "yes" on re-assessment was defined as less hesitant. Response of "not sure" or "yes" were defined as less hesitant for participants whose initial vaccination intent was "no".
Time Frame
Through survey completion, an average of 12 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (age 18 and over) who are members of an online panel (Prolific). Members of this panel joined the panel specifically to receive invitations to participate in research surveys and similar activities. Able to complete an online survey in English. Exclusion Criteria: • None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Fisher, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meyers Health Care Institute
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32886525
Citation
Fisher KA, Bloomstone SJ, Walder J, Crawford S, Fouayzi H, Mazor KM. Attitudes Toward a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults. Ann Intern Med. 2020 Dec 15;173(12):964-973. doi: 10.7326/M20-3569. Epub 2020 Sep 4.
Results Reference
background
PubMed Identifier
29611455
Citation
Brewer NT, Chapman GB, Rothman AJ, Leask J, Kempe A. Increasing Vaccination: Putting Psychological Science Into Action. Psychol Sci Public Interest. 2017 Dec;18(3):149-207. doi: 10.1177/1529100618760521.
Results Reference
background
PubMed Identifier
27235605
Citation
Godinho CA, Yardley L, Marcu A, Mowbray F, Beard E, Michie S. Increasing the intent to receive a pandemic influenza vaccination: Testing the impact of theory-based messages. Prev Med. 2016 Aug;89:104-111. doi: 10.1016/j.ypmed.2016.05.025. Epub 2016 May 25.
Results Reference
background
PubMed Identifier
27166824
Citation
Mowbray F, Marcu A, Godinho CA, Michie S, Yardley L. Communicating to increase public uptake of pandemic flu vaccination in the UK: Which messages work? Vaccine. 2016 Jun 14;34(28):3268-74. doi: 10.1016/j.vaccine.2016.05.006. Epub 2016 May 8.
Results Reference
background
PubMed Identifier
25936726
Citation
Nowak GJ, Sheedy K, Bursey K, Smith TM, Basket M. Promoting influenza vaccination: insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2015 Jun 4;33(24):2741-56. doi: 10.1016/j.vaccine.2015.04.064. Epub 2015 Apr 28.
Results Reference
background
PubMed Identifier
22044740
Citation
Redelings MD, Piron J, Smith LV, Chan A, Heinzerling J, Sanchez KM, Bedair D, Ponce M, Kuo T. Knowledge, attitudes, and beliefs about seasonal influenza and H1N1 vaccinations in a low-income, public health clinic population. Vaccine. 2012 Jan 5;30(2):454-8. doi: 10.1016/j.vaccine.2011.10.050. Epub 2011 Oct 30.
Results Reference
background

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Views on COVID-19 and Vaccination

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