CompletedNot applicableNCT05386355
Official study title

Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool

Study summary

This study will determine the effectiveness of a vaccine communication mobile health app on parental decisions to vaccinate their children against coronavirus disease 2019 (COVID-19). The hypothesis is that unvaccinated children of caregivers assigned to the Vaccine Uptake app will be more likely to achieve COVID-19 vaccine series completion than those children whose caregivers are assigned to the General Health app.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedCOVID-19 Vaccine Uptake App and General Health App

The study team can explain what participation involves.

Who it may be forCOVID-19 Vaccines · Telemedicine

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 11, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?IDeA States Pediatric Clinical Trials Network

Study sponsor

01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Not applicable
Sponsor
IDeA States Pediatric Clinical Trials Network
Interventions being studied
Behavioral: COVID-19 Vaccine Uptake App; Other: General Health App
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Parent/Caregiver
  • Age of majority, as defined by the state of residency
  • Access to a mobile device that can store and run the study app for 24 weeks. Devices that can run the app include mobile phones and tablets running Android or iOS operating systems
  • Able to speak and read in English or Spanish
  • Be a parent/caregiver with primary medical decision-making and legal authority to consent to vaccination decisions for at least one child who meets the child inclusion criteria Child Inclusion Criteria:
  • Age 6 months to less than age of majority, as defined by the child's state of residence
  • Has not received any doses of COVID-19 vaccine based on parent/caregiver report
  • Eligible to receive COVID-19 vaccine
  • Patient at a participating clinic Parent/Caregiver
Reasons someone may not be able to joinExclusion criteria
  • Has only a child or children with known contraindication to all COVID-19 vaccines
  • Has only a child or children whose other parent/caregiver is already a current or past participant in the study
  • Has a child or children enrolled in any other COVID-19 vaccine study of any kind
  • Past or present participation in a COVID-19 vaccine or behavioral trial
  • Has a cognitive impairment that limits their ability to engage with the app content and/or make medical decisions regarding vaccination, based on the site investigator's assessment and local human subjects research policies Child

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arkansas Children's Research InstituteLittle Rock, Arkansas
  • Nemours Children's HealthWilmington, Delaware
  • Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii
  • University of Kansas Medical CenterKansas City, Kansas
  • Norton Children's Research InstituteLouisville, Kentucky
  • Our Lady of the Lake Regional Medical CenterBaton Rouge, Louisiana
  • University of Mississippi Medical CenterJackson, Mississippi
  • University of Nebraska Medical CenterOmaha, Nebraska
  • Dartmouth Hitchcock ClinicLebanon, New Hampshire
  • University of New Mexico Health Sciences CenterAlbuquerque, New Mexico
  • University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma
  • Rhode Island HospitalProvidence, Rhode Island

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 11, 2025. Always confirm current availability with the study team.

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