CoronavirusNCT04731870
Exploring Vaccine Confidence and Uptake of Potential COVID-19 Vaccines
An observational study of Coronavirus, run by East Carolina University at 1 site in United States.
Trial summary
The COVID-19 pandemic has highlighted deleterious US health inequities. Specifically, African Americans, Latinos, and Native Americans have and continue to shoulder a greater burden of COVID-19 infections and deaths in the US. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Survey research
- Type of treatment
- Vaccines
- How many people
- 632 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Objectives 1 and 2 will be met by administering an electronic quantitative survey among the following four distinct groups: 1) Nurses (at least 50% from the south), 2) Primary Care/Family Physicians (at least 50% from the south), 3) Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and 4) Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American). Each group will contain at least 150 subjects for a total of 600 participants.
Who may be able to join
- Nurses (at least 50% from the south),
- Primary Care/Family Physicians (at least 50% from the south),
- Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and
- Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Carol Belk Building
Greenville, North Carolina, 27858
About this study
Official title: Exploring Vaccine Confidence and Uptake of Potential COVID-19 Vaccines Among a Cross-section of US Healthcare Providers and Key At-risk Subgroups in the Rural South
The COVID-19 pandemic has highlighted deleterious US health inequities. Specifically, African Americans, Latinos, and Native Americans have and continue to shoulder a greater burden of COVID-19 infections and deaths in the US. In addition to existing racial and ethnic disparities are rural health and regional disparities. Given the disproportionate impact of disease in US communities of color and also in rural and southern regions of the US, there is no doubt that these at-risk subgroups will continue to experience higher rates of coronavirus-related mortality as well as other long-term health outcomes as compared to other US populations.
It is unknown how healthcare providers and other key at-risk subgroups within the US will receive COVID-19 vaccines. For success in immunizations, the US will need to reach their most at-risk and vulnerable populations. In addition to at-risk populations, a successful immunization strategy will involve engaging providers to support clear, consistent, and strong vaccine recommendation. It is critical to build vaccine trust, confidence, and overall acceptance of COVID-19 vaccines among healthcare providers and key at-risk subgroups, especially given the accelerated production timeline of these vaccines. Likewise, tailored vaccine messaging for key subgroups is vital in achieving vaccine confidence and trust.
The proposed study will explore perceptions, confidence, trust, and uptake of potential COVID-19 vaccines among healthcare providers (nurses and doctors) and key at-risk population subgroups (minority populations living in the rural south) and will develop and test vaccine messaging that boosts vaccine confidence and trust among these key at-risk subgroups.
Read the detailed description
Study objectives are as follows: Objective 1: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine recommendation practices, and trust in the health system and public health authorities among a cross-section of healthcare providers in the US (nurses and physicians); Objective 2: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine uptake, and trust in the health system, in healthcare providers, and in public health authorities among key at-risk subgroups in the US (minority populations living in the rural south); and Objective 3: To develop, tailor, and test COVID-19 vaccine messaging to boost vaccine confidence and trust, and COVID-19 preventive behavior, among at-risk subgroups in the US (minority populations living in the rural south). Perceptions, confidence, uptake, and trust in potential COVID-19 vaccines will be assessed among four identified and distinct groups via a quantitative and electronic survey and qualitative focus groups with key at-risk subgroups will be utilized to develop, tailor, and test COVID-19 vaccine messaging for at-risk subgroups.
This study will: 1) provide important national-level data regarding healthcare provider vaccine perceptions, confidence, trust, and projected vaccine recommendation practices for COVID-19, 2) ascertain vaccine perceptions, confidence, trust, and projected uptake of potential COVID-19 vaccines among at-risk populations in the US, and 3) develop tailored messaging for at-risk populations that can be used to boost vaccine confidence and trust, and preventive behaviors, among these high-risk groups in the coming years. This study will help to inform a larger coordinated national promotion strategy and campaign that can work to effectively communicate with the public about potential COVID-19 vaccines.
- Conditions
- Coronavirus
- Being tested
- Survey research
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey researchOther
This is not an intervention study. It involves social science research of surveys and focus groups.
| Study group | Role | What they receive |
|---|---|---|
| Nurses/Doctors | Covid-19 vaccine confidence and recommendation practices of nurses/doctors Receives: Other: Survey research | |
| Minority populations living in rural south | Covid-19 vaccine confidence and uptake of key at-risk subgroups and tailored Covid-10 vaccine messaging for at-risk subgroups. Receives: Other: Survey research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 vaccine confidence (survey to be developed by study team)
Confidence in the Covid-19 vaccine efficacy and safety among a cross-section of healthcare providers and key at-risk subgroups in the US
Measured: year 1
Covid-19 vaccine messaging (messages to be developed by study team & focus group participants)
COVID-19 vaccine messaging (e.g. one or two sentences of culturally appropriate messages) that can be used to boost vaccine confidence and trust, and COVID-19 preventive behavior, among at-risk subgroups in the US (minority populations living in the rural south).
Measured: year 2
Covid-19 vaccine uptake (survey to be developed by study team)
COVID-19 vaccine uptake or projected uptake among a cross-section of healthcare providers and key at-risk subgroups in the US
Measured: year 1
Covid-19 vaccine trust (survey to be developed by study team)
COVID-19 vaccine trust in the health system and public health authorities a cross-section of healthcare providers and key at-risk subgroups in the US
Measured: year 1
Covid-19 vaccine recommendation practices (survey to be developed by study team)
COVID-19 vaccine recommendation practices among a cross-section of healthcare providers in the US
Measured: year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start28 Feb 2021
- Primary completion1 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Becky Welch, CPA, Study chair, Assistant Vice Chancellor for Research Administration & Finance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731870
- Sponsor's protocol ID
- 60622
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Vaccine Confidence and Uptake of Potential COVID-19 Vaccines Among a Cross-section of US Healthcare Providers and Key At-risk Subgroups in the Rural South
- ClinicalTrials.gov ID
- NCT04731870
- Acronym / sponsor ID
- 60622
- Conditions
- Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic has highlighted deleterious US health inequities. Specifically, African Americans, Latinos, and Native Americans have and continue to shoulder a greater burden of COVID-19 infections and deaths in the US. In addition to existing racial and ethnic disparities are rural health and regional disparities. Given the disproportionate impact of disease in US communities of color and also in rural and southern regions of the US, there is no doubt that these at-risk subgroups will continue to experience higher rates of coronavirus-related mortality as well as other long-term health outcomes as compared to other US populations.
It is unknown how healthcare providers and other key at-risk subgroups within the US will receive COVID-19 vaccines. For success in immunizations, the US will need to reach their most at-risk and vulnerable populations. In addition to at-risk populations, a successful immunization strategy will involve engaging providers to support clear, consistent, and strong vaccine recommendation. It is critical to build vaccine trust, confidence, and overall acceptance of COVID-19 vaccines among healthcare providers and key at-risk subgroups, especially given the accelerated production timeline of these vaccines. Likewise, tailored vaccine messaging for key subgroups is vital in achieving vaccine confidence and trust.
The proposed study will explore perceptions, confidence, trust, and uptake of potential COVID-19 vaccines among healthcare providers (nurses and doctors) and key at-risk population subgroups (minority populations living in the rural south) and will develop and test vaccine messaging that boosts vaccine confidence and trust among these key at-risk subgroups.
Detailed description
Study objectives are as follows: Objective 1: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine recommendation practices, and trust in the health system and public health authorities among a cross-section of healthcare providers in the US (nurses and physicians); Objective 2: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine uptake, and trust in the health system, in healthcare providers, and in public health authorities among key at-risk subgroups in the US (minority populations living in the rural south); and Objective 3: To develop, tailor, and test COVID-19 vaccine messaging to boost vaccine confidence and trust, and COVID-19 preventive behavior, among at-risk subgroups in the US (minority populations living in the rural south). Perceptions, confidence, uptake, and trust in potential COVID-19 vaccines will be assessed among four identified and distinct groups via a quantitative and electronic survey and qualitative focus groups with key at-risk subgroups will be utilized to develop, tailor, and test COVID-19 vaccine messaging for at-risk subgroups.
This study will: 1) provide important national-level data regarding healthcare provider vaccine perceptions, confidence, trust, and projected vaccine recommendation practices for COVID-19, 2) ascertain vaccine perceptions, confidence, trust, and projected uptake of potential COVID-19 vaccines among at-risk populations in the US, and 3) develop tailored messaging for at-risk populations that can be used to boost vaccine confidence and trust, and preventive behaviors, among these high-risk groups in the coming years. This study will help to inform a larger coordinated national promotion strategy and campaign that can work to effectively communicate with the public about potential COVID-19 vaccines.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurses/Doctors | – | Other: Survey researchCovid-19 vaccine confidence and recommendation practices of nurses/doctors |
| Minority populations living in rural south | – | Other: Survey researchCovid-19 vaccine confidence and uptake of key at-risk subgroups and tailored Covid-10 vaccine messaging for at-risk subgroups. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Objectives 1 and 2 will be met by administering an electronic quantitative survey among the following four distinct groups: 1) Nurses (at least 50% from the south), 2) Primary Care/Family Physicians (at least 50% from the south), 3) Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and 4) Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American). Each group will contain at least 150 subjects for a total of 600 participants.
Key inclusion criteria (4 listed)
- Nurses (at least 50% from the south),
- Primary Care/Family Physicians (at least 50% from the south),
- Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and
- Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey researchThis is not an intervention study. It involves social science research of surveys and focus groups. | Other | Minority populations living in rural south, Nurses/Doctors |
Primary outcome
Covid-19 vaccine confidence (survey to be developed by study team)
Time frame: year 1
Confidence in the Covid-19 vaccine efficacy and safety among a cross-section of healthcare providers and key at-risk subgroups in the US
Covid-19 vaccine messaging (messages to be developed by study team & focus group participants)
Time frame: year 2
COVID-19 vaccine messaging (e.g. one or two sentences of culturally appropriate messages) that can be used to boost vaccine confidence and trust, and COVID-19 preventive behavior, among at-risk subgroups in the US (minority populations living in the rural south).
Covid-19 vaccine uptake (survey to be developed by study team)
Time frame: year 1
COVID-19 vaccine uptake or projected uptake among a cross-section of healthcare providers and key at-risk subgroups in the US
Covid-19 vaccine trust (survey to be developed by study team)
Time frame: year 1
COVID-19 vaccine trust in the health system and public health authorities a cross-section of healthcare providers and key at-risk subgroups in the US
Covid-19 vaccine recommendation practices (survey to be developed by study team)
Time frame: year 1
COVID-19 vaccine recommendation practices among a cross-section of healthcare providers in the US
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Welch, CPA study chair
Assistant Vice Chancellor for Research Administration & Finance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus, run by East Carolina University 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 4 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 27 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Covid-19 vaccine confidence (survey to be developed by study team) (time frame: year 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.