Clinical trial NCT06505993: Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia
Official title: COVID19 -- Health Communication and Structural Intervention Evaluation -- K-VAC: Kentucky Vaccinating All Communities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: COVID-19
Vaccine Hesitancy
Keywords: COVID-19
Multi-Level Intervention
Vaccine Hesitancy
Rural
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-07-17
Enrollment: 2250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The intervention trial will be a community-based, three-arm cluster randomized controlled trial. The three arms are: (1) multilevel invention (vaccine communication campaign + community-level structural intervention),(2) health communications only intervention, and (3) control/standard of care. Randomization will take place at the county level. The 15 participating counties will first be matched into blocks of three, with each block being matched as closely as possible on recent county influenza vaccination rates. After matching, the three counties within each matched block will be randomly assigned to one of the three study arms. This technique of randomizing to study arm within each matched block of counties increases confidence that community-level factors that might influence vaccine uptake are equally distributed across study arms. Following randomization, the intervention process will begin in counties in the multilevel and communication campaign intervention arms. Assessment of primary and secondary study outcomes will take place 6 months after initiation of the intervention. Finally, after assessment of outcomes is complete, the intervention components will be offered to the control counties.

Eligibility criteria: Up to 2,250 participants will take part in the study --- approximately 150 residents in each of the 15 participating Appalachian Kentucky Counties. In each of the fifteen counties, the investigators will collect survey data from 150 adults who are served by Homeplace, a medical and social services organization run by the UK Center for Excellence in Rural Health, which provides services in each of the 15 partner counties. Homeplace provides services to adults who are medically underserved and typically at 100-133% of the federal poverty level, primarily through service delivery by trained local Community Health Workers (CHWs). CHWs will recruit participants and collect the survey data from the identified individuals. Importantly, the criteria for qualification for Homeplace services are equivalent across the 15 counties, providing equivalence of sample across counties. A random sample of 150 individuals per county will be drawn from the Homeplace client database for that county. Gender, ethnic background, and health status will roughly mirror that of the demographics of the county.

Inclusion Criteria:

1. Must be a current Homeplace client
2. Live in one of the 15 selected study counties
3. Over the age of 18
4. Have the ability to complete the survey in English

Exclusion Criteria:

1. Not a current Homeplace client
2. Primary residence is not in one of the 15 study counties
3. Not within the ages of 18-99 years old
4. English is not your primary language

Primary outcomes:
measure: COVID-19 vaccination uptake
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: COVID-19 Vaccination Behaviors
timeFrame: Baseline and 6 months
measure: COVID-19 Attitudes
timeFrame: Baseline and 6 months
measure: COVID-19 Risk Perceptions
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Hazard
country: United States
facility: University of Kentucky Center of Excellence in Rural Health
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Marc T. Kiviniemi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Kathryn M. Cardarelli, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: