Clinical trial NCT05722652: A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
Official title: CONFIDENCE: A Pilot Randomized Control Trial With Waitlist Condition to Test a Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Vaccination
Keywords: Vaccination hesitancy
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Baystate Health
First posted: 2023-02-10
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will be using a cluster, randomized control trial design, in which clinics are assigned to either the intervention or control group. Clinics in the control group or "waitlist" condition, will receive the intervention approximately 12 months later.
Primary purpose: PREVENTION

Brief summary: The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.

Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.


Eligibility criteria: Practice site inclusion criteria

* Pediatric or family practice clinic that serves pediatric population (ages 5 to 17)
* Affiliated with UMass Memorial Health Care and/or Baystate Health
* Serve a patient population that is at least 30% racial/ethnic minority group members.

Inclusion Criteria for Parents:

The following inclusion criteria will be applied to parents (on behalf of their children):

* Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
* Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities
* Parent of patient at participating clinical site/child received non-urgent care visit during study period
* Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment.

Exclusion Criteria for Parents:

°Parent under age of 18

Primary outcomes:
measure: COVID-19 vaccine intention
timeFrame: Data collection will occur in the four weeks following implementation
Secondary outcomes:
measure: Feasibility: Recruitment
timeFrame: End of study; approximately 15 months
measure: Feasibility: Data Completeness
timeFrame: End of study; approximately 15 months
measure: Feasibility: Randomization
timeFrame: End of study; approximately 15 months
measure: Acceptability: Parents
timeFrame: Four to eight weeks post implementation
measure: Perceived appropriateness: Parents
timeFrame: Four to eight weeks post implementation
measure: Implementation Fidelity
timeFrame: Four to eight weeks post implementation
measure: Acceptability: Providers and clinic staff
timeFrame: Four to eight weeks post implementation
measure: Perceived Appropriateness: Providers and clinic staff
timeFrame: Four to eight weeks post implementation
measure: Perceived feasibility: Providers and clinic staff
timeFrame: Four to eight weeks post implementation
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Stephenie C Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan GW, Goulding M, Borg A, Minkah P, Beeler A, Rosal MC, Lemon SC. Development and Beta-Testing of the CONFIDENCE Intervention to Increase Pediatric COVID-19 Vaccination. J Pediatr Health Care. 2023 May-Jun;37(3):244-252. doi: 10.1016/j.pedhc.2022.11.002. Epub 2022 Nov 17.