Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

COVID-19 Clinical Trial

Official title:

Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293392
• Other study ID #: U54GM104941-09S1
• Secondary ID: U54GM104941-09S1
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: August 2023
• Source: Nemours Children's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5792
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Culturally-Tailored COVID-19 Vaccine Uptake Intervention
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.
• Standard Care
Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.

Locations

Country	Name	City	State
United States	Nemours Children's Hospital, Delaware	Wilmington	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
Nemours Children's Health System	ChristianaCare, National Institute of General Medical Sciences (NIGMS), University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months