Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia (K-VAC)

Marc Kiviniemi

Status: Invitation-only

Conditions: COVID-19; Vaccine Hesitancy

Treatments: Behavioral: Health Communication + Structural; Behavioral: Health Communication

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06505993

R01MD016864 (U.S. NIH Grant/Contract)

88486

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,250 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,250 participants in 3 patient groups

Health Communication

Experimental group

Description:

This intervention arm will include exclusively health communication messaging strategies that is both theory-based and community-targeted to encourage uptake of the COVID-19 vaccine delivered by trusted local communicators. Pre-identified theory-based components are attitudes, social norms, perceived behavioral control, response efficacy, and implementation intentions. The development process for the messaging will be based through a conjoint process of identification of theory- based determinants of decision-making relevant to the desired behavior change and a community-engaged process of identifying: a) community-specific messaging themes; b) trusted communicators within the target population; and c) community-specific messaging, imaging, and themes to achieve targeting.

Treatment:

Behavioral: Health Communication

Health Communication + Structural

Experimental group

Description:

This intervention arm will include the conditions outlined and included in the health communication arm, however, they will be coupled with a series of structural and/or environmental intervention strategies as well, which are targeted to facilitate vaccine accessibility and uptake among adults in the randomly assigned study counties.

Treatment:

Behavioral: Health Communication + Structural

Standard of Care

No Intervention group

Description:

No study-specific intervention strategies (as outlined above) will be implemented in control counties at the time of the study period. Any ongoing and/or pre-existing efforts within the scope of the project's outcomes will continue as it would have i.e. a health department operating a health fair.