Text4Vax: Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-25 Season

Not Applicable

Active, not recruiting

• Conditions: Influenza; COVID-19; Vaccination Hesitancy
• Interventions: Behavioral: Text message influenza and COVID-19 vaccine reminders; Behavioral: Text message influenza vaccine reminders; Behavioral: Text message COVID-19 vaccine reminders

• Registration Number: NCT06603090
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-10-02
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text message influenza and COVID-19 vaccine reminders	Text message influenza and COVID-19 vaccine reminders	Text message reminders for both influenza and COVID-19 vaccinations
Text message influenza vaccine reminders	Text message influenza vaccine reminders	Text message reminders only for influenza vaccination
Text message COVID-19 vaccine reminders	Text message COVID-19 vaccine reminders	Text message reminders only for COVID-19 vaccination

Primary Outcome Measures

Name	Time	Method
Timeliness of influenza vaccination	Up to December 31 each year, up to ~90 days	Days from study start to influenza vaccine up to December 31 each year
Timeliness of COVID-19 vaccination	Up to December 31 each year, up to ~90 days	Days from study start to COVID-19 vaccine up to December 31 each year

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year	~3 months	Receipt of influenza vaccine by December 31 each year
Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year	~3 months	Receipt of COVID-19 vaccine by December 31 each year
Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year	~7 months	Receipt of influenza vaccine by April 30 each year
Percentage of Participants Who Received COVID-19 Vaccine by April 30 Each Year	~7 months	Receipt of COVID-19 vaccine by April 30 each year
Timeliness of influenza vaccination	Up to April 30 each year, up to ~210 days	Days from study start to influenza vaccine up to April 30 each year
Timeliness of COVID-19 vaccination	Up to April 30 each year, up to ~210 days	Days from study start to COVID-19 vaccine up to April 30 each year

Trial Locations

Locations (4)

American Academy of Pediatrics; 🇺🇸 Itasca, Illinois, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States