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COVID-19 VaccinesMoVeUPNCT05386355

Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool

A study testing COVID-19 Vaccine Uptake App and General Health App in people with COVID-19 Vaccines and Telemedicine, run by IDeA States Pediatric Clinical Trials Network at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccines, Telemedicine, Vaccine Hesitancy
What is being tested?
COVID-19 Vaccine Uptake App and General Health App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,934 participants
Where
15 sitesUnited States
Study dates
18 Jul 2022to 25 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana, 70808

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96813

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dartmouth Hitchcock Clinic

    Lebanon, New Hampshire, 03756

  • Arkansas Children's Research Institute

    Little Rock, Arkansas, 72202

  • Norton Children's Research Institute

    Louisville, Kentucky, 40202

  • West Virginia University

    Morgantown, West Virginia, 26506

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Avera Research Institute

    Sioux Falls, South Dakota, 57108

  • Nemours Children's Health

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool: a Randomized, Controlled Trial

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.

Read the detailed description

This is a site-level block-randomized trial. The study population is Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who has not yet received the vaccine at the time of study enrollment.

The primary objective is to determine the effect of a parent-facing, vaccination decision-making mobile health (mHealth) tool on children's COVID-19 vaccine series completion. The endpoint of this objective is the proportion of children who complete COVID-19 vaccination, as verified in state, clinic, or participant-held records.

Secondary Objective 1 is to determine the effect of a parent-facing, vaccination decision-making mHealth tool on children's COVID-19 vaccine series initiation. The endpoint of this objective is the proportion of children who receive ≥1 dose of the COVID-19 vaccination series, as verified in state, clinic, or participant-held records

Secondary Objective 2 is to determine the effect of a parent-facing, vaccination decision-making mHealth tool on parental attitude toward pediatric COVID-19 vaccination. The endpoint of this objective is the change in enrolled parent/caregiver domain scores from baseline to week 16 on the modified World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) Vaccine Hesitancy Scale adapted for the COVID-19 Vaccine.

Enrolling sites will recruit participants. These sites will collaborate with outpatient practices within Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care services to children (<18 years old). Sites will serve a population base of at least 40% Medicaid/uninsured children, <60% non-Hispanic White children, or >40% of families residing in rural communities. Sites are encouraged, but not required, to have a high Spanish-speaking population.

Study interventions are a Vaccine Uptake App and General Health App. The Vaccine Uptake App will include 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.

The General Health App will include 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 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). Nudges regarding these topics will be sent to participants via push notifications to their mobile devices.

The study duration is 24 months (6 months study start-up; up to 8 months rolling enrollment; 7 months final participants' completion; 3 months analysis). Participant duration is 27 weeks.

Being tested
COVID-19 Vaccine Uptake App, General Health App
Keywords
COVID-19, COVID-19 vaccination, Pediatric COVID-19 vaccination, mobile health, mHealth
Medical subject headings
Vaccination Hesitancy, Precursor Cell Lymphoblastic Leukemia-Lymphoma, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Vaccine Uptake AppBehavioural

    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.

  • General Health AppOther

    A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.

Study groups in NCT05386355
Study groupRoleWhat they receive
Vaccine Uptake AppExperimental24-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.
Receives: Behavioral: COVID-19 Vaccine Uptake App
General Health AppActive 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.
Receives: Other: General Health App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (2)

  1. Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records

    For each vaccine-eligible child, this secondary endpoint will be defined as whether or not the child initiates the COVID-19 vaccine series during the 16 weeks of study participation. Vaccine series initiation will be receipt of at least 1 valid dose of any COVID-19 vaccine product. Vaccine doses for series initiation will only be valid for study purposes if given within the 16 weeks of study participation. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups with respect to the proportions of children who initiate COVID-19 vaccination, using site as a random effect and controlling for clustering by caregiver.

    Measured: Week 24

  2. 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

    The Strategic Advisory Group of Experts on Immunization (SAGE) working group on vaccine hesitancy developed a vaccine hesitancy measure, the Vaccine Hesitancy Scale (VHS). The study team will evaluate parental attitude toward pediatric COVID-19 vaccination by using the vaccine hesitancy questionnaire that includes ten statements with ordinal responses using a 5-point Likert scale (1=strongly disagree,...,5=strongly agree).

    A composite vaccine hesitancy score was computed based on the sum of the 10 items after reverse coding items 1, 2, 3, 4, 6, 7, and 8 (range of 10 to 50). The reverse coding allowed for directionality uniformed across the 10 items; therefore, higher composite score indicated more hesitancy overall. We report summary statistics including means and standard deviation at baseline and week 16. A linear mixed mode was used to account for parent/caregivers nested within clinics and allow adjustment for baseline SAGE composite score.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start18 Jul 2022
  3. Primary completion25 Sep 2023
  4. Study completion25 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will use a 1:1 parallel design at the caregiver level to assign caregivers to the intervention (Vaccine Uptake app) or the control (General Health app) arm. The study team will stratify randomization by participating clinic and in varying block of participants using a permuted design. Randomization will occur after enrollment and before the baseline assessment.
Masking
None (open label)
Enrolment
1,934 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386355
Sponsor's protocol ID
273761
Other IDs
U24OD024957
Acronym
MoVeUP
Status last verified
Feb 2025
First submitted
19 May 2022
Last updated
11 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 36307830

  • McCulloh 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.

    PubMed 36238712

Questions about this trial

What is this clinical trial studying?

A study testing COVID-19 Vaccine Uptake App and General Health App in people with COVID-19 Vaccines and Telemedicine, run by IDeA States Pediatric Clinical Trials Network at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386355, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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