Trial Outcomes & Findings for Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool (NCT NCT05386355)

Last Updated: 2025-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1934 participants

Primary outcome timeframe

Week 24

Results posted on

2025-03-11

Participant Flow

The protocol enrollment number of 727 represent the total number of parents/caregivers that were enrolled and randomized. For the study the unit of randomization is the parent/caregiver. The primary and secondary outcomes of interest, vaccine series completion and vaccine series initiation, were collected at the children level. Among these 727 parents/caregivers, there was a total of 1,207 children enrolled.

Participant milestones

Participant milestones
Measure	Vaccine Uptake App: Parents/Caregivers 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. COVID-19 Vaccine Uptake App: 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 App: Parents/Caregivers 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Vaccine Uptake App: Children 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. COVID-19 Vaccine Uptake App: 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 App: Children 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Overall Study STARTED	361	366	612	595
Overall Study COMPLETED	360	365	611	594
Overall Study NOT COMPLETED	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Uptake App: Parents/Caregivers 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. COVID-19 Vaccine Uptake App: 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 App: Parents/Caregivers 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Vaccine Uptake App: Children 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. COVID-19 Vaccine Uptake App: 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 App: Children 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Overall Study Each group had an ineligible child (i.e., one over 18 years old and one less than 6-months old).	1	1	1	1

Baseline Characteristics

Measure Description: Age was not collected for parent/caregiver.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine Uptake App: Parents/Caregivers n=360 Participants 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. COVID-19 Vaccine Uptake App: 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 App: Parents/Caregivers n=365 Participants 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Vaccine Uptake App: Children n=611 Participants 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. COVID-19 Vaccine Uptake App: 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 App: Children n=594 Participants 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Total n=1930 Participants Total of all reporting groups
Age, Customized Age, Customized · 6 months - 5 years	—	—	273 Participants n=611 Participants • Measure Description: Age was not collected for parent/caregiver.	271 Participants n=594 Participants • Measure Description: Age was not collected for parent/caregiver.	544 Participants n=1205 Participants • Measure Description: Age was not collected for parent/caregiver.
Age, Customized Age, Customized · 5 - 11 years	—	—	243 Participants n=611 Participants • Measure Description: Age was not collected for parent/caregiver.	224 Participants n=594 Participants • Measure Description: Age was not collected for parent/caregiver.	467 Participants n=1205 Participants • Measure Description: Age was not collected for parent/caregiver.
Age, Customized Age, Customized · 12 - 17 years	—	—	95 Participants n=611 Participants • Measure Description: Age was not collected for parent/caregiver.	99 Participants n=594 Participants • Measure Description: Age was not collected for parent/caregiver.	194 Participants n=1205 Participants • Measure Description: Age was not collected for parent/caregiver.
Sex/Gender, Customized Male	18 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	25 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	326 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	300 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	669 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Sex/Gender, Customized Female	341 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	340 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	285 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	294 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1260 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Sex/Gender, Customized Not listed/prefer not to answer	1 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Ethnicity (NIH/OMB) Hispanic or Latino	61 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	64 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	115 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	95 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	335 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Ethnicity (NIH/OMB) Not Hispanic or Latino	298 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	300 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	495 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	499 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1592 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	3 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	10 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	5 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	9 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	26 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) Asian	0 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	4 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	6 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	10 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	0 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	3 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	1 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	6 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) Black or African American	130 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	132 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	222 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	222 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	706 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) White	179 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	167 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	282 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	258 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	886 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) More than one race	17 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	19 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	52 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	50 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	138 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Race (NIH/OMB) Unknown or Not Reported	30 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	33 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	47 Participants n=611 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	48 Participants n=594 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.	158 Participants n=1930 Participants • The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row.
Caregiver Education <= High school or GED completed	94 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	60 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	154 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Caregiver Education Some college/technical/vocational	85 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	117 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	202 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Caregiver Education Bachelor's degree	45 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	45 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	90 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Caregiver Education Master's/Doctoral	23 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	23 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	46 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Caregiver Education Unknown/prefer not to answer	5 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	6 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	11 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Caregiver Education Missing	5 Participants n=257 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	4 Participants n=255 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	0 Participants For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).	9 Participants n=512 Participants • For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257).
Number of Children	1 Number of Children n=360 Participants • The number analyzed in the row represents the number of parent/caregiver since this measure is only relevant at the parent/caregiver level.	1 Number of Children n=365 Participants • The number analyzed in the row represents the number of parent/caregiver since this measure is only relevant at the parent/caregiver level.	—	—	1 Number of Children n=725 Participants • The number analyzed in the row represents the number of parent/caregiver since this measure is only relevant at the parent/caregiver level.
Rurality (self-reported) Yes	115 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.	134 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.	—	—	249 Participants n=725 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.
Rurality (self-reported) No	245 Participants n=360 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.	231 Participants n=365 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.	—	—	476 Participants n=725 Participants • The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level.

PRIMARY outcome

Timeframe: Week 24

Population: Randomization was at the parent/caregiver level; however, the unit of analysis for the primary (vaccine series completion) and secondary (vaccine series initiation) are at the children level. There were total of 1205 children (Vaccine Uptake N=611 and General Health N=595). Among the 1205, the vaccine completion outcome contained 11 missing observations (5 from Vaccine Uptake and 6 from General Health group).

Outcome measures

Outcome measures
Measure	Vaccine Uptake App: Children n=606 Participants 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. COVID-19 Vaccine Uptake App: 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 App: Children n=588 Participants 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Vaccine Uptake App: Children n=606 Participants 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. COVID-19 Vaccine Uptake App: 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 App: Children n=588 Participants 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records	22 Participants	25 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: The vaccine hesitancy secondary outcome is analyzed at the parent/caregiver level. Among the 725 parent/caregiver randomized, a total of 512 parent/caregiver completed the baseline survey.

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.

Outcome measures

Outcome measures
Measure	Vaccine Uptake App: Children n=257 Participants 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. COVID-19 Vaccine Uptake App: 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 App: Children n=255 Participants 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
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 score on a scale Interval 22.25 to 24.16	23.10 score on a scale Interval 22.27 to 23.93

Adverse Events

General Health App: Children

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vaccine Uptake App: Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Health App: Parents/Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaccine Uptake App: Parents/Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	General Health App: Children n=594 participants at risk 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Vaccine Uptake App: Children n=611 participants at risk 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. COVID-19 Vaccine Uptake App: 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 App: Parents/Caregivers n=365 participants at risk 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. General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.	Vaccine Uptake App: Parents/Caregivers n=360 participants at risk 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. COVID-19 Vaccine Uptake App: 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.
Metabolism and nutrition disorders Other	0.17% 1/594 • Number of events 1 • 32 weeks The unit of randomization was at the parent/caregiver level. We randomized 727 parent/caregiver (2 participants were ineligible with one participant having an only child over 18 years old while another participant had an only child under 6 months old). The unit of analysis is at the children level. There were a total of 1205 children (General Health App N=594 and Vaccine Uptake N=611). There were no adverse events reported at the parent/caregiver level.	0.00% 0/611 • 32 weeks The unit of randomization was at the parent/caregiver level. We randomized 727 parent/caregiver (2 participants were ineligible with one participant having an only child over 18 years old while another participant had an only child under 6 months old). The unit of analysis is at the children level. There were a total of 1205 children (General Health App N=594 and Vaccine Uptake N=611). There were no adverse events reported at the parent/caregiver level.	0.00% 0/365 • 32 weeks The unit of randomization was at the parent/caregiver level. We randomized 727 parent/caregiver (2 participants were ineligible with one participant having an only child over 18 years old while another participant had an only child under 6 months old). The unit of analysis is at the children level. There were a total of 1205 children (General Health App N=594 and Vaccine Uptake N=611). There were no adverse events reported at the parent/caregiver level.	0.00% 0/360 • 32 weeks The unit of randomization was at the parent/caregiver level. We randomized 727 parent/caregiver (2 participants were ineligible with one participant having an only child over 18 years old while another participant had an only child under 6 months old). The unit of analysis is at the children level. There were a total of 1205 children (General Health App N=594 and Vaccine Uptake N=611). There were no adverse events reported at the parent/caregiver level.

Additional Information

Songthip Ounpraseuth

University of Arkansas for Medical Sciences

Phone: 501-686-7233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place