Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

NCT ID: NCT05293392

Last Updated: 2023-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5792 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-05-20

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Culturally-Tailored COVID-19 Vaccine Uptake Intervention

Group Type EXPERIMENTAL

Culturally-Tailored COVID-19 Vaccine Uptake Intervention

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Care

Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role collaborator

ChristianaCare

OTHER

Sponsor Role collaborator

Nemours Children's Health System

OTHER

Sponsor Role lead

Responsible Party

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Thao-Ly Phan

Associate Professor of Pediatrics; Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thao-Ly T Phan-Vo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health

Locations

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Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Other Identifiers

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U54GM104941-09S1

Identifier Type: NIH

Identifier Source: secondary_id

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U54GM104941-09S1

Identifier Type: NIH

Identifier Source: org_study_id

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