Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-02 @ 11:20 PM
Study NCT ID:
NCT06505993
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-19
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing COVID-19 Vaccine Hesitancy With Muliti-Level Interventions in Appalachia
Sponsor:
Marc Kiviniemi
Organization:
Study Overview
Official Title:
COVID19 -- Health Communication and Structural Intervention Evaluation -- K-VAC: Kentucky Vaccinating All Communities
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K-VAC
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MD016864 | NIH | None | https://reporter.nih.gov/quic… | View |