Improving COVID-19 Vaccine Uptake Among Black and Latino Youth
Sponsor
Nemours Children's Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05293392
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH), University of Delaware (Other), ChristianaCare (Other)
20,606
1
2
3.6
5754.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20606 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities
Actual Study Start Date
:
Jan 31, 2022
Anticipated Primary Completion Date
:
May 20, 2022
Anticipated Study Completion Date
:
May 20, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Culturally-Tailored COVID-19 Vaccine Uptake 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.
|
| Active Comparator: Standard Care
|
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.
|
Outcome Measures
Primary Outcome Measures
- COVID-19 Vaccination Rate for Eligible Children [4 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nemours Children's Hospital, Delaware | Wilmington | Delaware | United States | 19803 |
Sponsors and Collaborators
- Nemours Children's Health System
- National Institute of General Medical Sciences (NIGMS)
- University of Delaware
- ChristianaCare
Investigators
- Principal Investigator: Thao-Ly T Phan-Vo, MD, MPH, Nemours Children's Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Thao-Ly Phan,
Associate Professor of Pediatrics; Research Scientist,
Nemours Children's Health System
ClinicalTrials.gov Identifier:
NCT05293392
Other Study ID Numbers:
- U54GM104941-09S1
- U54GM104941-09S1
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thao-Ly Phan,
Associate Professor of Pediatrics; Research Scientist,
Nemours Children's Health System
Additional relevant MeSH terms: