NCT05586165

Brief Summary

This randomized controlled trial investigates whether text-based reminders can increase the bivalent COVID-19 booster uptake and whether text-based reminders that mention the opportunity to bundle the COVID-19 booster with the flu shot within the same appointment can increase take-up of both the COVID-19 booster and the flu vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109,493

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

October 17, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

October 17, 2022

Last Update Submit

December 4, 2024

Conditions

COVID-19Vaccines

Keywords

COVID19VaccinesText-messagesPatient OutreachBehavioral ScienceBundling

Outcome Measures

Primary Outcomes (2)

  • booster take-up at UCLA/CVS in 2 weeks

    Whether people receive the bivalent booster at either UCLA Health or CVS Pharmacy

    2 weeks after getting the text message

  • booster take-up at UCLA/CVS in 4 weeks

    Whether people receive the bivalent booster at either UCLA Health or CVS Pharmacy

    4 week after getting the text message

Secondary Outcomes (7)

  • Link click rate in 1 week

    1 week after getting the text message

  • booster take-up in 2 weeks

    2 weeks after getting the text message

  • booster take-up in 4 weeks

    4 weeks after getting the text message

  • Flu vaccine take-up at UCLA/CVS in 2 weeks

    2 weeks after getting the text message

  • Flu vaccine take-up at UCLA/CVS in 4 weeks

    4 weeks after getting the text message

  • +2 more secondary outcomes

Study Arms (4)

Holdout

NO INTERVENTION

Simple Reminder

EXPERIMENTAL
Behavioral: Reminder to boost protection against COVID-19

Flu Tag Along

EXPERIMENTAL
Behavioral: Reminder to boost protection against COVID-19Behavioral: Flu Tag Along

Covid-19 Booster + Flu Bundle

EXPERIMENTAL
Behavioral: Reminder to boost protection against COVID-19Behavioral: COVID-19 Booster & Flu Bundle

Interventions

Reminder to boost protection against COVID-19BEHAVIORAL

Patients will receive a text message reminding them to enhance their protection against COVID-19 by getting the bivalent booster. The message will contain one link to schedule an appointment at UCLA Health and one link for scheduling an appointment at CVS Pharmacy.

Covid-19 Booster + Flu BundleFlu Tag AlongSimple Reminder
Flu Tag AlongBEHAVIORAL

This message will also encourage patients to protect themselves against the flu by asking for their flu vaccine at the booster appointment (at UCLA Health) or adding the flu vaccine to the COVID-19 vaccine booster appointment (at CVS).

Flu Tag Along
COVID-19 Booster & Flu BundleBEHAVIORAL

This message will simultaneously encourage patients to enhance their protection against COVID-19 and the flu and will inform them that, to save time, they can bundle two vaccines at once. Patients will learn that at UCLA Health, they can book an appointment for the booster and then ask for the flu vaccine at their appointment; at CVS Pharmacy, they can book one appointment to get both the bivalent COVID-19 booster and the flu vaccine.

Covid-19 Booster + Flu Bundle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 or above
  • Have a mobile phone number or SMS-capable phone number in UCLA Health's database
  • Having completed a COVID-19 vaccine primary series based on CAIR data
  • Last COVID-19 vaccine shot (including booster shot) occurred at least two months before the date when patient list are pulled in preparation for the trial, based on CAIR data. The last two criteria meant to identify patients who are eligible for the updated booster.

You may not qualify if:

  • Patients who have received the bivalent booster anywhere (based on CAIR data) before the day they receive the text message
  • Patients who have already scheduled appointments at UCLA Health for getting the bivalent booster before the day they receive the text message

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health Department of Medicine, Quality Office

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 19, 2022

Study Start

October 18, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)