COVID-19NCT05607082
COVID-19 Bivalent Booster Megastudy
A study testing COVID Booster text messages in people with COVID-19, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID Booster text messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- COVID-19
- Being tested
- COVID Booster text messages
- Keywords
- COVID-19 vaccination, behavioral science interventions, vaccination promotion
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID Booster text messagesBehavioural
Participants will receive text messages per descriptions listed in the arms.
| Study group | Role | What they receive |
|---|---|---|
| Holdout control condition with no message | No intervention | Participants will only receive the standard pharmacy messaging. |
| Control condition with "waiting for you" message | Experimental | 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. Receives: Behavioral: COVID Booster text messages |
| Control condition with "waiting for you" message with a GIF | Experimental | 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. Receives: Behavioral: COVID Booster text messages |
| Planning message recommending same time/location as last vaccination | Experimental | This condition will use a text message recommending the same time and location as the participant's last vaccination to get a COVID vaccination. Receives: Behavioral: COVID Booster text messages |
| Message from local pharmacy team | Experimental | This condition will use a text message from the participant's local pharmacist recommending a COVID vaccination. Receives: Behavioral: COVID Booster text messages |
| Message including link to resources combating misinformation | Experimental | This condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination. Receives: Behavioral: COVID Booster text messages |
| Message including link to resources combating misinformation with a GIF | Experimental | 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. Receives: Behavioral: COVID Booster text messages |
| Message offering free round trip ride to the pharmacy | Experimental | This condition will use a text message offering a free round trip ride to the pharmacy to get a COVID vaccination. Receives: Behavioral: COVID Booster text messages |
| Message communicating latest data on COVID transmission in patient's area | Experimental | 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. Receives: Behavioral: COVID Booster text messages |
| Message encouraging vaccination in preparation for the holidays | Experimental | This condition will use a text message to encourage a COVID vaccination in preparation for the holidays. Receives: Behavioral: COVID Booster text messages |
| Message conveying the CDC recommends vaccination | Experimental | This condition will use a text message to encourage a COVID vaccination by conveying the CDC recommends vaccination. Receives: Behavioral: COVID Booster text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient uptake of the COVID bivalent booster
Whether patients receive a bivalent COVID booster at the pharmacy in question
Measured: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes (2)
Patient uptake of the COVID bivalent booster
Whether patients receive a bivalent COVID booster at the pharmacy in question
Measured: 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
Measured: 90 days after receiving the SMS/MMS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start3 Nov 2022
- Primary completion8 Dec 2022
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the different arms.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 2,600,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607082
- Sponsor's protocol ID
- 851911
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Bivalent Booster Megastudy
- ClinicalTrials.gov ID
- NCT05607082
- Acronym / sponsor ID
- 851911
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccination, behavioral science interventions, vaccination promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 11
- Model description
- Participants will be randomly assigned to the different arms.
| Arm | Type | Receives |
|---|---|---|
| Holdout control condition with no message | No intervention | –Participants will only receive the standard pharmacy messaging. |
| Control condition with "waiting for you" message | Experimental | Behavioral: COVID Booster text messagesThis 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. |
| Control condition with "waiting for you" message with a GIF | Experimental | Behavioral: COVID Booster text messagesThis 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. |
| Planning message recommending same time/location as last vaccination | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message recommending the same time and location as the participant's last vaccination to get a COVID vaccination. |
| Message from local pharmacy team | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message from the participant's local pharmacist recommending a COVID vaccination. |
| Message including link to resources combating misinformation | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message including a link to to resources combating misinformation and then recommend a COVID vaccination. |
| Message including link to resources combating misinformation with a GIF | Experimental | Behavioral: COVID Booster text messagesThis 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. |
| Message offering free round trip ride to the pharmacy | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message offering a free round trip ride to the pharmacy to get a COVID vaccination. |
| Message communicating latest data on COVID transmission in patient's area | Experimental | Behavioral: COVID Booster text messagesThis 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. |
| Message encouraging vaccination in preparation for the holidays | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message to encourage a COVID vaccination in preparation for the holidays. |
| Message conveying the CDC recommends vaccination | Experimental | Behavioral: COVID Booster text messagesThis condition will use a text message to encourage a COVID vaccination by conveying the CDC recommends vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID Booster text messagesParticipants will receive text messages per descriptions listed in the arms. | Behavioural | Control condition with "waiting for you" message, Control condition with "waiting for you" message with a GIF, Message communicating latest data on COVID transmission in patient's area, Message conveying the CDC recommends vaccination, Message encouraging vaccination in preparation for the holidays, 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, Planning message recommending same time/location as last vaccination |
Primary outcome
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
2 secondary outcomes
Patient uptake of the COVID bivalent booster
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID Booster text messages in people with COVID-19, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient uptake of the COVID bivalent booster (time frame: During the 30 days after receiving the SMS/MMS intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.