COVID-19 Bivalent Booster Megastudy

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: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: COVID Booster text messages

• Study Type: Interventional
• Enrollment (Actual): 2600000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Patient uptake of the COVID bivalent booster	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

Outcome Measure	Measure Description	Time Frame
Patient uptake of the COVID bivalent booster	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	Whether patients receive a bivalent COVID booster at the pharmacy in question	90 days after receiving the SMS/MMS intervention

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 vaccination; behavioral science interventions; vaccination promotion
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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