Clinical trial · Interventional
Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool
Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool: a Randomized, Controlled Trial
NCT05386355CI-TRIAL-00086990MoVeUPcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 Vaccines | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Telemedicine | — | UNRESOLVED | — |
| Vaccine Hesitancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COVID-19 Vaccine Uptake App | Behavioral | — | UNRESOLVED |
| General Health App | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaccine Uptake App
- description
- 24-week (8 weeks with weekly push notifications; 2 monthly push notifications for 2 months \[1 notification per month\]; 8 weeks without) exposure to a mobile phone application (app) designed to improve parental knowledge, attitudes, and self-efficacy regarding pediatric COVID-19 vaccination. The app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will also receive eight weekly nudges and 1 monthly nudge for 2 months (cues to action) regarding vaccinating their child that will be sent to participants via push notifications to their mobile devices. Through branching logic, users will access content tailored to their COVID-19 vaccine knowledge and confidence gaps, locality, degree of rural-urban primary residence, primary language (English/Spanish), race/ethnicity, and child's age.
- interventionNames
- Behavioral: COVID-19 Vaccine Uptake App
- type
- ACTIVE_COMPARATOR
- label
- General Health App
- description
- 24-week (8 with weekly push notifications; 2 monthly push notifications for 2 months \[1 notification per month\]; 8 weeks without) exposure to a mobile phone app designed to provide information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). Eight weekly nudges and 1 monthly nudge for 2 months regarding these topics will be sent to participants via push notifications to their mobile devices.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMcCulloh RJ, Darden PM, Snowden J, Ounpraseuth S, Lee J, Clarke M, Newcomer SR, Fu L, Hubberd D, Baldner J, Garza M, Kerns E. Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial. Trials. 2022 Oct 28;23(1):911. doi: 10.1186/s13063-022-06819-3. PMID 36307830
- DERIVEDMcCulloh RJ, Darden P, Snowden J, Ounpraseuth S, Lee J, Clarke M, Newcomer SR, Fu L, Hubberd D, Baldner J, Garza M, Kerns E. Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUP): a randomized, controlled trial. Res Sq [Preprint]. 2022 Oct 10:rs.3.rs-2070396. doi: 10.21203/rs.3.rs-2070396/v1. PMID 36238712