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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05537714
Other study ID # 22-0682
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 6, 2023
Est. completion date August 31, 2024

Study information

Verified date September 2023
Source East Carolina University
Contact Alice Richman, PhD
Phone 2523471959
Email richmana@ecu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Qualitative interviews/focus groups
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.

Locations

Country Name City State
United States East Carolina University Greenville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Primary 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. 2 years
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