COVID-19 Bivalent Booster Megastudy

March 1, 2023 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2600000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control condition with "waiting for you" message
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.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message communicating latest data on COVID transmission in patient's area
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.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
No Intervention: Holdout control condition with no message
Participants will only receive the standard pharmacy messaging.
Experimental: Control condition with "waiting for you" message with a GIF
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.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Planning message recommending same time/location as last 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.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message from local pharmacy team
This condition will use a text message from the participant's local pharmacist recommending a COVID vaccination.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message including link to resources combating misinformation
This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message including link to resources combating misinformation with a GIF
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.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message offering free round trip ride to the pharmacy
This condition will use a text message offering a free round trip ride to the pharmacy to get a COVID vaccination.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message encouraging vaccination in preparation for the holidays
This condition will use a text message to encourage a COVID vaccination in preparation for the holidays.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.
Experimental: Message conveying the CDC recommends vaccination
This condition will use a text message to encourage a COVID vaccination by conveying the CDC recommends vaccination.
Behavioral: COVID Booster text messages
Participants will receive text messages per descriptions listed in the arms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient uptake of the COVID bivalent booster
Time Frame: During the 30 days after receiving the SMS/MMS intervention
Whether patients receive a bivalent COVID booster at the pharmacy in question
During the 30 days after receiving the SMS/MMS intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient uptake of the COVID bivalent booster
Time Frame: 60 days after receiving the SMS/MMS intervention
Whether patients receive a bivalent COVID booster at the pharmacy in question
60 days after receiving the SMS/MMS intervention
Patient uptake of the COVID bivalent booster
Time Frame: 90 days after receiving the SMS/MMS intervention
Whether patients receive a bivalent COVID booster at the pharmacy in question
90 days after receiving the SMS/MMS intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 851911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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