Vaccine HesitancyNCT05537714
Advancing Vaccine Equity Through Understanding Vaccine Hesitancy, Barriers, and Trust
An observational study of Vaccine Hesitancy and Structural Barriers, run by East Carolina University at 1 site in United States.
Trial summary
In the proposed study, the investigators will conduct qualitative interviews and focus groups with Black, Hispanic, and medically underserved communities, living in the rural south and will provide a quantitative survey (mixed methods) to identify reasons for vaccine hesitancy, including any structural barriers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Structural Barriers, Vaccine Trust
- What is being tested?
- Qualitative interviews/focus groups
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2023to 31 Aug 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eastern North Carolina (ENC) is a largely rural, poor, and underserved region of the state with 1 in 5 adults living below the poverty level, and nearly half living in a community designated as rural. Health in ENC is significantly poorer than health in the rest of NC, and health in the ENC-29 counties is poorest of all. Of the 40 counties in NC that are most economically distressed, 19 (48%) are in the ENC-29-county sub- region. Residents of ENC experience a high burden of health disparities driven by limited access to healthcare and inequitable distribution of social determinants of health.
Inclusion Criteria: All English or Spanish speaking adults 18 years or older. -
Exclusion Criteria: Anyone over 18 years of age who does not speak English or Spanish or anyone under 18 years of age.
-
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Alice Richman, 252-328-6431, richmana@ecu.edu
About this study
Official title: Advancing Vaccine Equity: A Mixed-methods Study to Understand Vaccine Hesitancy, Structural Barriers, and Trust in Vaccine Information Among Medically Underserved Populations Living in the Rural South
In the proposed study, the investigators will conduct qualitative interviews and focus groups with Black, Hispanic, and medically underserved communities, living in the rural south and will provide a quantitative survey (mixed methods) to identify reasons for vaccine hesitancy, including any structural barriers experienced by this population. The investigators will assess what vaccination messaging was received by trusted individuals and how this messaging may have impacted vaccination behavior. This mixed methods study design will allow for a comprehensive picture of vaccine equity and hesitancy for this population. The quantitative survey provides a focused and concrete uncovering of the issues and relationships and the qualitative design allows for a detailed, contextualized insight into lived experiences. Coupled together, this mixed methods design will provide a rich depiction of the underlying drivers of vaccine hesitancy, structural barriers to vaccination, and messaging that impacted uptake for medically underserved and rural populations.
Read the detailed description
Objective 1: To identify reasons for vaccine hesitancy, structural barriers to vaccination, vaccine messaging received, and vaccination behavior among medically underserved and vulnerable populations living in the rural south.
Objective 2: To assess vaccine messaging from trusted individuals (e.g., clergy/church leaders, community health workers, and community leaders) who serve medically underserved and vulnerable populations living in the rural south.
Objective 3: To identify best vaccine confidence and uptake strategies to improve vaccine acceptance, confidence, and trust among medically underserved and vulnerable populations living in the rural south.
Hypotheses:
H1a. It is hypothesized that top reasons for vaccine hesitancy may include access to care issues (such as transportation, long wait times, no available appointments, not sure where to go, no internet, and language barriers), safety and efficacy concerns, distrust in government and health organizations, as well as lack of information and/or misinformation.
H1b. It is hypothesized that structural barriers to vaccination may include geographic barriers, access to information, clinic/outlet location or trusted points of access, internet access, immigrant status, language, transportation, among others.
H1c. It is hypothesized that vaccine messaging received from trusted individuals in the communities (i.e., faith-based leaders, community health workers, and community leaders) will have impacted confidence and uptake more so than other vaccine messaging efforts.
H2. It is hypothesized that the vaccine messaging from trusted individuals will be mixed with some messaging based on science and some based on anecdotal evidence. It is not well-known what messages are being delivered around vaccination from trusted individuals who serve our priority population and thus, we can only hypothesize that the messaging will vary.
H3. It is hypothesized that the most effective strategies to boost vaccine confidence and uptake for vaccine hesitant, medically underserved, and vulnerable populations living in the rural south will include culturally tailored messaging from engagement with trusted individuals.
- Conditions
- Vaccine Hesitancy, Structural Barriers, Vaccine Trust
- Being tested
- Qualitative interviews/focus groups
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviews/focus groupsBehavioural
We will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 vaccine hesitant, Black, Hispanic, and medical underserved individuals living in rural eastern North Carolina (ENC) and with 40 trusted individuals such as clergy/church leaders, community health workers, and community leaders who serve these populations.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine hesitant | We will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 vaccine hesitant, Black, Hispanic, and medical underserved individuals living in rural eastern North Carolina (ENC) Receives: Behavioral: Qualitative interviews/focus groups | |
| Trusted community leaders | We will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 trusted individuals such as clergy/church leaders, community health workers, and community leaders who serve medical underserved individuals living in rural eastern North Carolina (ENC) . Receives: Behavioral: Qualitative interviews/focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of community members
Topical guide questions for community members will include questions regarding vaccine hesitancy, barriers experienced to vaccination, vaccine messaging likes and dislikes, trust in vaccine message deliverers, and vaccination behavior for self and children.
Measured: 2 years
Perceptions of community leaders
Topical guide questions for trusted individuals will include questions regarding vaccine hesitancy of themselves, vaccine hesitancy of the populations they serve, perceived barriers to vaccination of those they serve, vaccine beliefs and attitudes, trust in vaccine messaging delivered from government/healthcare system, and experience in delivering vaccine messaging to the populations they serve.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start6 Aug 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537714
- Sponsor's protocol ID
- 22-0682
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data can be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Vaccine Equity: A Mixed-methods Study to Understand Vaccine Hesitancy, Structural Barriers, and Trust in Vaccine Information Among Medically Underserved Populations Living in the Rural South
- ClinicalTrials.gov ID
- NCT05537714
- Acronym / sponsor ID
- 22-0682
- Conditions
- Vaccine Hesitancy, Structural Barriers, Vaccine Trust
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 13 Sep 2022 (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.
In the proposed study, the investigators will conduct qualitative interviews and focus groups with Black, Hispanic, and medically underserved communities, living in the rural south and will provide a quantitative survey (mixed methods) to identify reasons for vaccine hesitancy, including any structural barriers experienced by this population. The investigators will assess what vaccination messaging was received by trusted individuals and how this messaging may have impacted vaccination behavior. This mixed methods study design will allow for a comprehensive picture of vaccine equity and hesitancy for this population. The quantitative survey provides a focused and concrete uncovering of the issues and relationships and the qualitative design allows for a detailed, contextualized insight into lived experiences. Coupled together, this mixed methods design will provide a rich depiction of the underlying drivers of vaccine hesitancy, structural barriers to vaccination, and messaging that impacted uptake for medically underserved and rural populations.
Detailed description
Objective 1: To identify reasons for vaccine hesitancy, structural barriers to vaccination, vaccine messaging received, and vaccination behavior among medically underserved and vulnerable populations living in the rural south.
Objective 2: To assess vaccine messaging from trusted individuals (e.g., clergy/church leaders, community health workers, and community leaders) who serve medically underserved and vulnerable populations living in the rural south.
Objective 3: To identify best vaccine confidence and uptake strategies to improve vaccine acceptance, confidence, and trust among medically underserved and vulnerable populations living in the rural south.
Hypotheses:
H1a. It is hypothesized that top reasons for vaccine hesitancy may include access to care issues (such as transportation, long wait times, no available appointments, not sure where to go, no internet, and language barriers), safety and efficacy concerns, distrust in government and health organizations, as well as lack of information and/or misinformation.
H1b. It is hypothesized that structural barriers to vaccination may include geographic barriers, access to information, clinic/outlet location or trusted points of access, internet access, immigrant status, language, transportation, among others.
H1c. It is hypothesized that vaccine messaging received from trusted individuals in the communities (i.e., faith-based leaders, community health workers, and community leaders) will have impacted confidence and uptake more so than other vaccine messaging efforts.
H2. It is hypothesized that the vaccine messaging from trusted individuals will be mixed with some messaging based on science and some based on anecdotal evidence. It is not well-known what messages are being delivered around vaccination from trusted individuals who serve our priority population and thus, we can only hypothesize that the messaging will vary.
H3. It is hypothesized that the most effective strategies to boost vaccine confidence and uptake for vaccine hesitant, medically underserved, and vulnerable populations living in the rural south will include culturally tailored messaging from engagement with trusted individuals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine hesitant | – | Behavioral: Qualitative interviews/focus groupsWe will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 vaccine hesitant, Black, Hispanic, and medical underserved individuals living in rural eastern North Carolina (ENC) |
| Trusted community leaders | – | Behavioral: Qualitative interviews/focus groupsWe will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 trusted individuals such as clergy/church leaders, community health workers, and community leaders who serve medical underserved individuals living in rural eastern North Carolina (ENC) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eastern North Carolina (ENC) is a largely rural, poor, and underserved region of the state with 1 in 5 adults living below the poverty level, and nearly half living in a community designated as rural. Health in ENC is significantly poorer than health in the rest of NC, and health in the ENC-29 counties is poorest of all. Of the 40 counties in NC that are most economically distressed, 19 (48%) are in the ENC-29-county sub- region. Residents of ENC experience a high burden of health disparities driven by limited access to healthcare and inequitable distribution of social determinants of health.
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 |
|---|---|---|
| Qualitative interviews/focus groupsWe will conduct quantitative (survey) and qualitative assessments (interviews/focus groups) with 40 vaccine hesitant, Black, Hispanic, and medical underserved individuals living in rural eastern North Carolina (ENC) and with 40 trusted individuals such as clergy/church leaders, community health workers, and community leaders who serve these populations. | Behavioural | Trusted community leaders, Vaccine hesitant |
Primary outcome
Perceptions of community members
Time frame: 2 years
Topical guide questions for community members will include questions regarding vaccine hesitancy, barriers experienced to vaccination, vaccine messaging likes and dislikes, trust in vaccine message deliverers, and vaccination behavior for self and children.
Perceptions of community leaders
Time frame: 2 years
Topical guide questions for trusted individuals will include questions regarding vaccine hesitancy of themselves, vaccine hesitancy of the populations they serve, perceived barriers to vaccination of those they serve, vaccine beliefs and attitudes, trust in vaccine messaging delivered from government/healthcare system, and experience in delivering vaccine messaging to the populations they serve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. Deidentified data can be shared upon reasonable request.
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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.
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 Vaccine Hesitancy and Structural Barriers, 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?
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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Richman, PhD (2523471959, richmana@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of community members (time frame: 2 years). The study lists 2 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 28 Sep 2023.