An interventional study of Communication from a physician about the COVID-19 Vaccine in Covid19, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Prevention
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 756 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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?")
Behavioral: Communication from a physician about the COVID-19 Vaccine
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").
Behavioral: Communication from a physician about the COVID-19 Vaccine
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").
Behavioral: Communication from a physician about the COVID-19 Vaccine
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").
Behavioral: Communication from a physician about the COVID-19 Vaccine
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").
Behavioral: Communication from a physician about the COVID-19 Vaccine
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.
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".
Time frame: Through survey completion, an average of 12 minutes
Participants were recruited on Prolific.co from 01/12/21-02/01/21. Eligible panel members were \>= 18, English speaking, and U.S residents. Panel members were restricted to include White, Black, or Hispanic; Blacks and Hispanics were oversampled. Participants who responded "no" or "not sure" to "If you could get vaccinated for COVID-19 today, would you?" were classified as vaccine hesitant and randomized to receive 1 of 5 physician messages, after which their intent was reassessed.
| Milestone | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 |
|---|---|---|---|---|---|
| Started | 172 | 121 | 165 | 146 | 152 |
| Completed | 172 | 121 | 164 | 145 | 150 |
| Not completed | 0 | 0 | 1 | 1 | 2 |
| Withdrew: Participants did not provide respond to the question re-assessing vaccination intent | 0 | 0 | 1 | 1 | 2 |
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".
| Participants | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 |
|---|---|---|---|---|---|
| Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message | 23 | 26 | 43 | 35 | 40 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Message 1 | — | — | — |
| Message 2 | — | — | — |
| Message 3 | — | — | — |
| Message 4 | — | — | — |
| Message 5 | — | — | — |
| Age, Customized(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Age — Less than 24 years | 43 | 31 | 37 | 38 | 41 | 190 |
| Age — 25 - 34 years | 40 | 32 | 42 | 28 | 42 | 184 |
| Age — 35 - 44 years | 50 | 27 | 31 | 50 | 33 | 191 |
| Age — 45 - 54 years | 22 | 21 | 27 | 17 | 20 | 107 |
| Age — 55 - 64 years | 13 | 4 | 20 | 10 | 11 | 58 |
| Age — 65 years or older | 3 | 5 | 3 | 2 | 2 | 15 |
| Age — Missing | 1 | 1 | 4 | 0 | 1 | 7 |
| Sex/Gender, Customized(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Gender — Male | 62 | 41 | 71 | 52 | 65 | 291 |
| Gender — Female | 108 | 78 | 88 | 93 | 82 | 449 |
| Gender — Other | 0 | 2 | 4 | 0 | 0 | 6 |
| Gender — Prefer not to say | 1 | 0 | 0 | 0 | 0 | 1 |
| Gender — Missing | 1 | 0 | 1 | 0 | 3 | 5 |
| Race/Ethnicity, Customized(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Hispanic/Latino | 35 | 31 | 41 | 33 | 37 | 177 |
| Black/African American | 79 | 52 | 66 | 64 | 65 | 326 |
| White | 58 | 37 | 57 | 48 | 48 | 248 |
| Missing | 0 | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| United States | 172 | 121 | 164 | 145 | 150 | 752 |
| Initial Vaccination Intent(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Initially "No" | 103 | 66 | 83 | 78 | 81 | 411 |
| Initially "Not Sure" | 69 | 55 | 81 | 67 | 69 | 341 |
| Education(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| High School or Less | 44 | 40 | 53 | 38 | 49 | 224 |
| Some college | 86 | 56 | 85 | 70 | 68 | 365 |
| 4-year college or more | 42 | 25 | 25 | 36 | 32 | 160 |
| Missing | 0 | 0 | 1 | 1 | 1 | 3 |
| Employment(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Employed | 88 | 64 | 83 | 83 | 76 | 394 |
| Unemployed | 30 | 20 | 29 | 20 | 30 | 129 |
| Student | 25 | 15 | 15 | 19 | 18 | 92 |
| Homemaker | 16 | 12 | 9 | 14 | 13 | 64 |
| Disabled | 6 | 3 | 10 | 4 | 5 | 28 |
| Retired | 3 | 3 | 7 | 4 | 4 | 21 |
| Other | 4 | 3 | 10 | 1 | 4 | 22 |
| Missing | 0 | 1 | 1 | 0 | 0 | 2 |
| Household Income(Participants) | Message 1 | Message 2 | Message 3 | Message 4 | Message 5 | Total |
|---|---|---|---|---|---|---|
| Less than $30,000 | 47 | 43 | 55 | 40 | 57 | 242 |
| $30,000 - $60,000 | 53 | 41 | 57 | 51 | 53 | 255 |
| $60,000 - $100,000 | 44 | 27 | 35 | 26 | 27 | 159 |
| More than $100,000 | 21 | 7 | 11 | 19 | 9 | 67 |
| Prefer not to answer | 6 | 2 | 5 | 9 | 3 | 25 |
| Missing | 1 | 1 | 1 | 0 | 1 | 4 |
4 further baseline measures are reported on the registry.
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University of Massachusetts, Worcester