Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool
MoVeUP
2 other identifiers
interventional
1,934
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2023
CompletedResults Posted
Study results publicly available
March 11, 2025
CompletedMarch 11, 2025
February 1, 2025
1.2 years
May 19, 2022
September 26, 2024
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records
Initiation and completion of the COVID-19 vaccine series during the 24-week intervention period. Vaccine series completion will be per ACIP guidance for the vaccine product. For children who receive a product that requires more than 2 doses for the primary series, receipt of up to 3 doses will be considered complete. Vaccine doses will be valid if given within 24-week study intervention. Additional doses for primary series completion will be valid if they are in accordance with ACIP-recommended interval minus a 4-day grace period. There will be no maximum interval between valid doses. An incorrect second vaccine product (i.e., mixed series) will be invalid. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups and the proportions of children who complete COVID-19 vaccination, using a site random effect and controlling for clustering by caregiver.
Week 24
Secondary Outcomes (2)
Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records
Week 24
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
16 weeks
Study Arms (2)
Vaccine Uptake App
EXPERIMENTAL24-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.
General Health App
ACTIVE COMPARATOR24-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.
Interventions
A mHealth mobile application (app) that will provide educational and logistical information about the COVID-19 vaccination for children. The target audience will be parents of unvaccinated children.
A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDeA States Pediatric Clinical Trials Networklead
- National Institutes of Health (NIH)collaborator
- University of Nebraskacollaborator
- University of Montanacollaborator
Study Sites (15)
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202, United States
Nemours Children's Health
Wilmington, Delaware, 19803, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Children's Research Institute
Louisville, Kentucky, 40202, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Clinic
Lebanon, New Hampshire, 03756, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (2)
McCulloh 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: 36307830DERIVEDMcCulloh 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: 36238712DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Songthip Ounpraseuth
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Russell J. McCulloh, MD
University of Nebraska
- PRINCIPAL INVESTIGATOR
Ellen Kerns, PhD
University of Nebraska
- PRINCIPAL INVESTIGATOR
Paul Darden, MD
University of Arkansas
- STUDY DIRECTOR
Songthip T Ounpraseuth, PhD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 23, 2022
Study Start
July 18, 2022
Primary Completion
September 25, 2023
Study Completion
September 25, 2023
Last Updated
March 11, 2025
Results First Posted
March 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- Per data sharing polices of NIH and the ISPCTN
- Access Criteria
- to be announced
We will conduct this trial in accordance with the following publication and data sharing policies and regulations: * NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. * ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. * NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Jeannette Lee, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).