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Covid19NCT04706403

Views on COVID-19 and Vaccination

A study testing Communication from a physician about the COVID-19 Vaccine in people with Covid19, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Communication from a physician about the COVID-19 Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
1 siteUnited States
Study dates
12 Jan 2021to 1 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Meyers Health Care Institute

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Covid19
Being tested
Communication from a physician about the COVID-19 Vaccine
Keywords
Covid-19, Vaccination
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Communication from a physician about the COVID-19 VaccineBehavioural

    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.

Study groups in NCT04706403
Study groupRoleWhat they receive
Message 1ExperimentalParticipants 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?")
Receives: Behavioral: Communication from a physician about the COVID-19 Vaccine
Message 2ExperimentalParticipants 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").
Receives: Behavioral: Communication from a physician about the COVID-19 Vaccine
Message 3ExperimentalParticipants 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").
Receives: Behavioral: Communication from a physician about the COVID-19 Vaccine
Message 4ExperimentalParticipants 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").
Receives: Behavioral: Communication from a physician about the COVID-19 Vaccine
Message 5ExperimentalParticipants 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").
Receives: Behavioral: Communication from a physician about the COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: Through survey completion, an average of 12 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start12 Jan 2021
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706403
Sponsor's protocol ID
H00022244
Status last verified
May 2022
First submitted
5 Jan 2021
Last updated
24 May 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32886525
  • 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.

    PubMed 29611455
  • 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.

    PubMed 27235605
  • 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.

    PubMed 27166824
  • 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.

    PubMed 25936726
  • 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.

    PubMed 22044740

Questions about this trial

What is this clinical trial studying?

A study testing Communication from a physician about the COVID-19 Vaccine in people with Covid19, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message (time frame: Through survey completion, an average of 12 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706403, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.

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Views on COVID-19 and Vaccination (NCT04706403) | AzTrials