NCT05293392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,792

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

March 22, 2022

Results QC Date

July 25, 2023

Last Update Submit

August 31, 2023

Conditions

COVID-19

Keywords

Healthcare disparitiesVaccine hesitancy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Culturally-Tailored COVID-19 Vaccine Uptake Intervention

EXPERIMENTAL
Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention

Standard Care

ACTIVE COMPARATOR
Behavioral: Standard Care

Interventions

Culturally-Tailored COVID-19 Vaccine Uptake InterventionBEHAVIORAL

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.

Culturally-Tailored COVID-19 Vaccine Uptake Intervention
Standard CareBEHAVIORAL

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

Standard Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Hospital, Delaware

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

COVID-19Vaccination Hesitancy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Thao-Ly Phan, MD, MPH
Organization
Nemours Children's Health
thaoly.phan@nemours.org
302-331-7342

Study Officials

  • Thao-Ly T Phan-Vo, MD, MPH

    Nemours Children's Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics; Research Scientist

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 24, 2022

Study Start

January 31, 2022

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)