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COVID-19 Bivalent Booster Megastudy

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID Booster text messages
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring COVID-19 vaccination, behavioral science interventions, vaccination promotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series. Exclusion Criteria: The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Holdout control condition with no message

Control condition with "waiting for you" message

Control condition with "waiting for you" message with a GIF

Planning message recommending same time/location as last vaccination

Message from local pharmacy team

Message including link to resources combating misinformation

Message including link to resources combating misinformation with a GIF

Message offering free round trip ride to the pharmacy

Message communicating latest data on COVID transmission in patient's area

Message encouraging vaccination in preparation for the holidays

Message conveying the CDC recommends vaccination

Arm Description

Participants will only receive the standard pharmacy messaging.

This control condition will use the text message that we've found to be the best performing in our last mega-study of vaccine text messages to recommend a COVID vaccination.

This control condition will use the text message that we've found to be the best performing in our last mega-study of vaccine text messages and includes a GIF to recommend a COVID vaccination.

This condition will use a text message recommending the same time and location as the participant's last vaccination to get a COVID vaccination.

This condition will use a text message from the participant's local pharmacist recommending a COVID vaccination.

This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination.

This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination and will include a GIF.

This condition will use a text message offering a free round trip ride to the pharmacy to get a COVID vaccination.

This condition will use a text message informing the participant of the latest data on COVID transmission in participant's area and recommend a COVID vaccination.

This condition will use a text message to encourage a COVID vaccination in preparation for the holidays.

This condition will use a text message to encourage a COVID vaccination by conveying the CDC recommends vaccination.

Outcomes

Primary Outcome Measures

Patient uptake of the COVID bivalent booster
Whether patients receive a bivalent COVID booster at the pharmacy in question

Secondary Outcome Measures

Patient uptake of the COVID bivalent booster
Whether patients receive a bivalent COVID booster at the pharmacy in question
Patient uptake of the COVID bivalent booster
Whether patients receive a bivalent COVID booster at the pharmacy in question

Full Information

First Posted
November 3, 2022
Last Updated
March 1, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05607082
Brief Title
COVID-19 Bivalent Booster Megastudy
Official Title
COVID-19 Bivalent Booster Megastudy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This megastudy is a massive randomized controlled trial. By randomizing participants to 10 different intervention conditions simultaneously, the investigators will be able to compare the effectiveness of different interventions to one another and to a control group (in which individuals will only receive the usual communications from their partner organization) to identify which interventions significantly increase vaccination rates. Pharmacy customers will be randomly assigned to receive one of the interventions designed by team scientists to encourage vaccination or to a control group. The baseline intervention will be based on the top-performing SMS intervention identified in the investigators previous megastudies on encouraging vaccination (Milkman et al., 2021b, 2022). Pharmacy customers will receive SMS messages conveying that a COVID booster vaccine is reserved or waiting for them at the pharmacy. Additional behavioral science messaging strategies will be tested by building off of this baseline intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 vaccination, behavioral science interventions, vaccination promotion

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to the different arms.
Masking
Care ProviderOutcomes Assessor
Masking Description
As treated participants will receive text messages, there is no scope for blinding. Care providers will not be made aware of subjects' participation in the study, or assigned treatment arms. The study team will only receive data on subjects' assigned arms and outcomes at the end of the study.
Allocation
Randomized
Enrollment
2600000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holdout control condition with no message
Arm Type
No Intervention
Arm Description
Participants will only receive the standard pharmacy messaging.
Arm Title
Control condition with "waiting for you" message
Arm Type
Experimental
Arm Description
This control condition will use the text message that we've found to be the best performing in our last mega-study of vaccine text messages to recommend a COVID vaccination.
Arm Title
Control condition with "waiting for you" message with a GIF
Arm Type
Experimental
Arm Description
This control condition will use the text message that we've found to be the best performing in our last mega-study of vaccine text messages and includes a GIF to recommend a COVID vaccination.
Arm Title
Planning message recommending same time/location as last vaccination
Arm Type
Experimental
Arm Description
This condition will use a text message recommending the same time and location as the participant's last vaccination to get a COVID vaccination.
Arm Title
Message from local pharmacy team
Arm Type
Experimental
Arm Description
This condition will use a text message from the participant's local pharmacist recommending a COVID vaccination.
Arm Title
Message including link to resources combating misinformation
Arm Type
Experimental
Arm Description
This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination.
Arm Title
Message including link to resources combating misinformation with a GIF
Arm Type
Experimental
Arm Description
This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination and will include a GIF.
Arm Title
Message offering free round trip ride to the pharmacy
Arm Type
Experimental
Arm Description
This condition will use a text message offering a free round trip ride to the pharmacy to get a COVID vaccination.
Arm Title
Message communicating latest data on COVID transmission in patient's area
Arm Type
Experimental
Arm Description
This condition will use a text message informing the participant of the latest data on COVID transmission in participant's area and recommend a COVID vaccination.
Arm Title
Message encouraging vaccination in preparation for the holidays
Arm Type
Experimental
Arm Description
This condition will use a text message to encourage a COVID vaccination in preparation for the holidays.
Arm Title
Message conveying the CDC recommends vaccination
Arm Type
Experimental
Arm Description
This condition will use a text message to encourage a COVID vaccination by conveying the CDC recommends vaccination.
Intervention Type
Behavioral
Intervention Name(s)
COVID Booster text messages
Intervention Description
Participants will receive text messages per descriptions listed in the arms.
Primary Outcome Measure Information:
Title
Patient uptake of the COVID bivalent booster
Description
Whether patients receive a bivalent COVID booster at the pharmacy in question
Time Frame
During the 30 days after receiving the SMS/MMS intervention
Secondary Outcome Measure Information:
Title
Patient uptake of the COVID bivalent booster
Description
Whether patients receive a bivalent COVID booster at the pharmacy in question
Time Frame
60 days after receiving the SMS/MMS intervention
Title
Patient uptake of the COVID bivalent booster
Description
Whether patients receive a bivalent COVID booster at the pharmacy in question
Time Frame
90 days after receiving the SMS/MMS intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series. Exclusion Criteria: The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COVID-19 Bivalent Booster Megastudy

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