A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Clinics will know if they are assigned to the intervention or control condition. However, individual participants (parents of children ages 5 to 17) will not know if their clinic is in the intervention or control condition.

Study Groups

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Intervention Condition

Group Type EXPERIMENTAL

CONFIDENCE

Intervention Type BEHAVIORAL

This clinic-based, multicomponent intervention consists of 3 parts:

1. Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents
2. Parent-facing educational materials about COVID-19 vaccination
3. Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination

Waitlist Condition

Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.

Group Type ACTIVE_COMPARATOR

CONFIDENCE

Intervention Type BEHAVIORAL

This clinic-based, multicomponent intervention consists of 3 parts:

1. Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents
2. Parent-facing educational materials about COVID-19 vaccination
3. Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination

Interventions

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CONFIDENCE

This clinic-based, multicomponent intervention consists of 3 parts:

1. Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents
2. Parent-facing educational materials about COVID-19 vaccination
3. Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* 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.