N/A
Completed N=1,934
Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool
COVID-19 Vaccines · Telemedicine · vaccine hesitancy · Pediatric ALL
Source: ClinicalTrials.gov NCT05386355 ↗
Enrolled (actual)
1,934
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records — 13; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records |
13; 7 | — |
| SECONDARY Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records |
22; 25 | — |
| SECONDARY Change in Enrolled Parent/Caregiver Domain Scores From Baseline to Immediately Post-intervention on the Modified WHO SAGE Vaccine Hesitancy Scale Adapted for the COVID-19 Vaccine |
23.33; 23.10 | 0.638 |
Eligibility Criteria
Parent/Caregiver Inclusion Criteria:
- 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 Exclusion 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 Exclusion Criteria:
- Not a patient of a participating clinic
- Prior receipt of least one dose of COVID-19 vaccine
- Receiving or scheduled to receive COVID-19 vaccination at the time of parental consent
- Known medical contraindication to all COVID-19 vaccines
- Ineligible to receive COVID-19 vaccine
- Prior or current participation in a COVID-19 vaccine study of any kind
Data sourced from ClinicalTrials.gov (NCT05386355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.