Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia
NCT Number: NCT06505993
Acronym: K-VAC
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID-19|Vaccine Hesitancy
Interventions: BEHAVIORAL: Health Communication|BEHAVIORAL: Health Communication + Structural
Sponsor: Marc Kiviniemi
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2026-06
Locations: University of Kentucky Center of Excellence in Rural Health, Hazard, Kentucky, 41701, United States

Summary:
The purpose of this community-engaged study is to test the ability of county-level strategies to increase uptake of COVID-19 vaccination. In this study the key objective is to test whether health communication strategies or health communication + county-specific structural/environmental support increases COVID-19 vaccine uptake and changes perceptions and beliefs about the vaccination at the county-level.

Primary Outcome Measures: COVID-19 vaccination uptake, Change in \*county-level\* vaccination rates- to assess uptake, the investigators will ascertain the number of individuals in each county who received the COVID-19 vaccination during the intervention period as well as during an equivalent time frame prior to the intervention. This assessment will be obtained from existing, deidentified vaccination rate data maintained by the KY Department of Public Health. The primary outcome variable will be the number of individuals receiving vaccination., Baseline and 6 months
Secondary Outcome Measures: COVID-19 Vaccination Behaviors, The investigators will assess individual-level vaccination behaviors with a survey among adults in each study county. To capture, participants will be asked to self-report their responses to following statements with multiple choice answer choices provided to allow for quantitative analysis: 1) "Have you or do you think you have had COVID-19?" 1= Yes I was tested or a doctor diagnosed me; 2= Maybe I had some symptoms but was not tested; 3= No. 2) "How many times have you had COVID-19?" 1= Once, 2= Twice, 3= Three or more times. Additionally, the investigators will use a 4-point Likert scale (1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree) to assess respondent likeliness of intention to vaccinate with either a COVID-19 booster, or COVID-19 vaccine, in the next 12-months., Baseline and 6 months|COVID-19 Attitudes, The investigators will assess individual-level vaccination attitudes and beliefs with a survey among adults in each study county. Participants will be asked to self-report their responses to following statements utilizing a 4-point Likert scale (1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree):

1. "I feel safe about getting the COVID-19 vaccine."
2. "The COVID-19 vaccine may cause short term problems, like fever or discomfort."
3. "The COVID-19 vaccine is being pushed to make money for drug companies."
4. "The COVID-19 vaccine was not tested enough for safety."
5. "The COVID-19 vaccine may cause lasting health problems."
6. "I am concerned that the COVID-19 vaccine will cost more than I can pay."
7. "The COVID-19 vaccine was developed too quickly.", Baseline and 6 months|COVID-19 Risk Perceptions, The investigators will assess individual-level risk perceptions about vaccination with a survey among adults in each study county. Participants will be asked to self-report their responses to following questions with a 4-point Likert scale:

1. "How likely are you to get COVID-19 in the next 6 months?" 1= very unlikely to 4= very likely
2. "How afraid are you of getting COVID-19 in the next 6 months?" 1= not afraid at all to 4= extremely afraid
3. "If you were to get COVID-19 in the next 6 months, how serious would it be?" 1= not serious at all to 4= extremely serious, Baseline and 6 months