- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537714
Advancing Vaccine Equity Through Understanding Vaccine Hesitancy, Barriers, and Trust
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alice Richman, PhD
- Phone Number: 2523471959
- Email: richmana@ecu.edu
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27858
- Recruiting
- East Carolina University
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Contact:
- Alice Richman
- Phone Number: 252-328-6431
- Email: richmana@ecu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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)
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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.
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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) .
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceptions of community members
Time Frame: 2 years
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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.
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2 years
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Perceptions of community leaders
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-0682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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