COVID-19 Bivalent Booster Megastudy

NCT ID: NCT05607082

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2600000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to the different arms.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Holdout control condition with no message

Participants will only receive the standard pharmacy messaging.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

Message from local pharmacy team

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

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

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.

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

Message conveying the CDC recommends vaccination

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

Group Type EXPERIMENTAL

COVID Booster text messages

Intervention Type BEHAVIORAL

Participants will receive text messages per descriptions listed in the arms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVID Booster text messages

Participants will receive text messages per descriptions listed in the arms.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

851911

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.