Clinical trial NCT06603090: Text4Vax: Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-25 Season
Official title: Text4Vax: Understanding the Effectiveness and Implementation of Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-2025 Season
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Influenza
COVID-19
Vaccination Hesitancy
Keywords: text message
Short message service (SMS)
mHealth
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: American Academy of Pediatrics
name: University of Pennsylvania
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-09-19
Enrollment: 50000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This multi-site study assesses the impact of text message reminders on the receipt of COVID-19 and influenza text message reminders takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

Detailed description: The study is to be conducted over the 1st season (September 2024-April 2025) as an effectiveness trial and the 2nd (September 2025-April 2026) as a replication study. This protocol covers the first season. Parents of eligible children who are 6 month-17 year-old who are due for both a COVID-19 and influenza vaccine will be sent text messages. Within each practice site, parents of eligible children will be randomized to receive either: 1) combined COVID-19 and influenza vaccine text message reminders, 2) COVID-19 reminders alone, 3) influenza reminders alone, or 4) no reminders (usual care).

Randomization is to be stratified by practice site, age group and prior year's COVID-19/influenza vaccine history. Messages will be sent centrally and managed by the research team.

Eligibility criteria: Inclusion Criteria:

* Child that:

  * is 6 months-17 year-old children
  * due for both a COVID-19 and influenza vaccine
* Receives care at study site
* Language listed in electronic health record is English or Spanish
* Has not opted out of text messages from practice

Exclusion Criteria:

* Has opted out of text messages from practice
* Language listed in electronic health record is not English or Spanish

Primary outcomes:
measure: Timeliness of influenza vaccination
timeFrame: Up to December 31 each year, up to ~90 days
measure: Timeliness of COVID-19 vaccination
timeFrame: Up to December 31 each year, up to ~90 days
Secondary outcomes:
measure: Timeliness of influenza vaccination
timeFrame: Up to April 30 each year, up to ~210 days
measure: Timeliness of COVID-19 vaccination
timeFrame: Up to April 30 each year, up to ~210 days
measure: Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year
timeFrame: ~3 months
measure: Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year
timeFrame: ~3 months
measure: Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year
timeFrame: ~7 months
measure: Percentage of Participants Who Received COVID-19 Vaccine by April 30 Each Year
timeFrame: ~7 months
Other outcomes:
Locations:
city: Itasca
country: United States
facility: American Academy of Pediatrics
state: Illinois
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Alex Fiks, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: