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Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
Standard Care
Sponsored by
Nemours Children's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring Healthcare disparities, Vaccine hesitancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Youth 0-21 years of age and their caregiver
  • Receiving care at one of four Nemours primary care practices selected for this study

Exclusion Criteria:

  • None

Sites / Locations

  • Nemours Children's Hospital, Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culturally-Tailored COVID-19 Vaccine Uptake Intervention

Standard Care

Arm Description

Outcomes

Primary Outcome Measures

COVID-19 Vaccination Rate for Eligible Children
Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
August 31, 2023
Sponsor
Nemours Children's Health System
Collaborators
National Institute of General Medical Sciences (NIGMS), University of Delaware, ChristianaCare
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1. Study Identification

Unique Protocol Identification Number
NCT05293392
Brief Title
Improving COVID-19 Vaccine Uptake Among Black and Latino Youth
Official Title
Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Health System
Collaborators
National Institute of General Medical Sciences (NIGMS), University of Delaware, ChristianaCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Healthcare disparities, Vaccine hesitancy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5792 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
Arm Type
Experimental
Arm Title
Standard Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
Intervention Description
This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.
Primary Outcome Measure Information:
Title
COVID-19 Vaccination Rate for Eligible Children
Description
Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth 0-21 years of age and their caregiver Receiving care at one of four Nemours primary care practices selected for this study Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thao-Ly T Phan-Vo, MD, MPH
Organizational Affiliation
Nemours Children's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Hospital, Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

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