AzTrials
AzTrials

COVID-19NCT05586204

Boost Intentions and Facilitate Action to Promote COVID-19 Booster Take-up

A study testing Eligibility reminder, Link to a narrow set of vaccine venues and Link to a broad set of vaccine venues in people with COVID-19 and Vaccines, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text messages affect the take-up of bivalent COVID-19 booster. The investigators will test the impact of sending text reminders as well as the importance of elevating vaccination intentions, facilitating action, and their… 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, Vaccines
What is being tested?
Eligibility reminder, Link to a narrow set of vaccine venues and Link to a broad set of vaccine venues
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154,977 participants
Where
1 siteUnited States
Study dates
18 Oct 2022to 31 Dec 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

  • Patients aged 18 or above
  • Have a mobile phone number or SMS-capable phone number in UCLA Health's database
  • Having completed a COVID-19 vaccine primary series based on CAIR data
  • Last COVID-19 vaccine shot (including booster shot) occurred at least two months before the date when patient list are pulled in preparation for the trial, based on CAIR data. The last two criteria are meant to identify patients who are eligible for the bivalent booster.

Who cannot join

  • Patients who have received the bivalent booster anywhere (based on CAIR data) before the day they receive the text message
  • Patients who have already scheduled appointments at UCLA Health for getting the bivalent booster before the day they receive the text message

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Health Department of Medicine, Quality Office

    Los Angeles, California, 90095

Other trials in United States

About this study

This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text messages affect the take-up of bivalent COVID-19 booster. The investigators will test the impact of sending text reminders as well as the importance of elevating vaccination intentions, facilitating action, and their combination.

Read the detailed description

Shortly after COVID-19 bivalent boosters were authorized, UCLA Health emailed its patients encouraging them to get the covid booster either at UCLA Health or at local pharmacies. The investigators plan to conduct a randomized controlled trial, several weeks after this initial communication, to test how text-based reminders that boost intentions and/or facilitate action affect the take-up of COVID-19 bivalent boosters. Among all UCLA Health patients eligible to receive the COVID-19 bivalent booster, the investigators will randomly select 35% for this trial, 40% for another trial (Pre-registration title: "Information Provision and Consistency Framing to Increase COVID-19 Booster Uptake") and 25% for a third trial (Pre-registration title: "Effects of Prompt to Bundle Covid-19 Booster and Flu Shot"). The three trials will be run simultaneously.

Patients randomly selected for this trial will be randomized at an equal share to 6 conditions: an Holdout condition that does not receive a text reminder and 5 additional conditions that receive a text message (Facilitate Action Narrowly, Facilitate Action Broadly, Boost Intention, Boost Intentions+Facilitate Action Narrowly, Boost Intentions+Facilitate Action Broadly; see description in the Arm/Interventions section). Within each arm, patients are further randomized into one of the 33 time slots for when they will receive the text message (i.e., 3 time points per day including 9am, 12pm, 4pm for 11 days). Days 1-4 and 8-11 have slightly fewer patients than Days 5-7.

To test whether reminders that facilitate action by providing appointment scheduling links increase vaccine uptake, the investigators will compare the holdout condition to the combination of the 4 arms that contain appointment scheduling links.

With this trial, the investigators will investigate several additional research questions.

  1. The investigators will investigate the value of simultaneously elevating intentions and facilitating action. The investigators will compare vaccine uptake between the holdout arm and (1) the combination of the two action-only messages (i.e., the Facilitate Action Narrowly arm and the Facilitate Action Broadly arm), (2) the intention-only message (i.e., the Boost Intention arm), and (3) the combination of the two intention-action messages (i.e., the Boost Intentions+Facilitate Action Narrowly arm and the Boost Intentions+Facilitate Action Broadly arm). Then the investigators will compare vaccine uptake between (1) the combination of the two action-only messages and (2) the intention-only message versus (3) the combination of the two intention-action messages.the investigators will also compare link click rates between the combination of the two action-only messages and the combination of the two intention-action messages.
  2. The investigators will investigate whether facilitating action narrowly or broadly is better at promoting vaccine uptake. For that purpose, the investigators will compare vaccine uptake and link click rates between the combination of the two messages facilitating action narrowly (i.e., the Facilitate Action Narrowly arm and the Boost Intentions+Facilitate Action Narrowly arm) and the combination of the two messages facilitating action broadly (i.e., the Facilitate Action Broadly arm and the Boost Intentions+Facilitate Action Broadly arm). The investigators will also compare vaccine uptake between these two sets of messages and the holdout condition.
  3. The investigators will explore how the effects of text reminders encouraging people to get vaccinated at specific (narrow) locations vary by the scope and horizon of vaccine uptake measure. For this purpose, the investigators will compare the combination of the two messages containing links to UCLA/CVS with the holdout condition, and the investigators will analyze both vaccine uptake at UCLA/CVS and vaccine uptake in California and both at 2 weeks and 4 weeks. The investigators will do the same analyses for the additive effect of boosting intentions (vs. only having the links to UCLA/CVS)..
  4. The investigators will explore the role of the time when a text message is sent. The investigators will examine how the effect of text reminders facilitating action (i.e., the combination of the 4 arms with appointment scheduling links vs. holdout) varies across days and times. As additional specifications, the investigators will control for the time trend and analyze all patients who have not gotten the bivalent booster in California or scheduled a booster appointment at UCLA Health the day before the trial starts.
  5. Given that the investigators are simultaneously conducting three trials in the same population, the investigators may combine data from three trials and compare vaccine uptake between the reminder arms and the average of the holdout arms from the three trials to identify the most effective reminder in a mega-study fashion by following the approach in Milkman et al. (2021).

Analysis:

The investigators will run ordinary least squares regressions (OLS) with robust standard errors to predict the aforementioned outcome variables, except that the investigators will use a Cox proportional hazards model with administrative censoring to predict time of obtaining the booster. The significance level will be 0.05. The regressions will include the following control variables:

  • Indicators for one of the 33 time slots
  • Participant age (If there will be a missing value, the investigators will replace with the mean and add a dummy variable to indicate patients with missing age)
  • Indicators for participant race/ethnicity (Black non-Hispanic, Hispanic, Asian non-Hispanic, white non-Hispanic, other/mixed, unknown)
  • Indicators for participant gender (male, female, other/unknown)
  • The investigators will test whether the main effect of sending text reminders to facilitate action (i.e., the combination of the 4 reminder arms with appointment scheduling links vs. holdout) is robust regardless of:
  • Whether the patient is female or male
  • Whether the patient is white non-hispanic or racial/ethnical minority
  • Whether the patient is 65+ (including 65) or below 65

The investigators will investigate the following moderators for (1) the effect of sending text reminders to facilitate action, (2) the additive effect of adding appointment scheduling links (vs. only boosting intentions), and (3) the additive effect of boosting intentions (vs. only facilitating action with appointment scheduling links):

  • Timing of the first dose of the COVID-19 vaccine primary series
  • Whether patients got at least one original booster prior to the trial
  • Whether or not the patient received a flu shot in either the 2020-2021 season or the 2021-2022 flu season according to the patient's medical record
  • How strongly the patient's neighborhood is in favor of the Republican (vs. Democratic) Party if UCLA Health eventually agrees to provide de-identified addresses (e.g., zip code) and if the sample contains patients living in Republican-leaning counties.

Additional information: Three days into this trial, the investigators learned that the supply of boosters at UCLA Health is very limited and patients could not find appointments at UCLA Health. The investigators verified that local pharmacies continue to have appointments available. Thus, the investigators updated all text messages to (1) explain that UCLA Health has limited booster appointments available, (2) no longer provide a direct link to schedule appointments at UCLA Health, and (3) instead encourage patients to make an appointment at either CVS Pharmacy or local pharmacies (depending on the arm). As a result, instead of analyzing the originally preregistered outcome measures of "booster take-up at UCLA/CVS in 2 weeks" and "booster take-up at UCLA/CVS in 4 weeks", the investigators will measure vaccine uptake at CVS in 2 weeks and 4 weeks. In terms of the outcome measure of "Link click rate in 1 week", the investigators will still look at whether patients click on any link in the text message.

Conditions
COVID-19, Vaccines
Being tested
Eligibility reminder, Link to a narrow set of vaccine venues, Link to a broad set of vaccine venues, Doctors' recommendation and value of vaccine
Keywords
COVID19, Vaccines, Text-messages, Patient Outreach, Behavioral Science
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eligibility reminderBehavioural

    Patients will receive a reminder of their eligibility for the bivalent COVID-19 booster

  • Link to a narrow set of vaccine venuesBehavioural

    The reminder will encourage people to claim their dose today by booking an appointment. It will contain a link to schedule a booster appointment at UCLA Health and a link to CVS pharmacy

  • Link to a broad set of vaccine venuesBehavioural

    The reminder will encourage people to claim their dose today by booking an appointment. It will contain a link to schedule a booster appointment at UCLA Health and a link to vaccine.gov (where people can find a wide set of local pharmacies that carry the bivalent booster).

  • Doctors' recommendation and value of vaccineBehavioural

    The reminder will contain information about the value of the bivalent booster and doctors' recommendation to get it

Study groups in NCT05586204
Study groupRoleWhat they receive
Facilitate action narrowlyExperimentalNot described
Receives: Behavioral: Eligibility reminder; Behavioral: Link to a narrow set of vaccine venues
Facilitate action broadlyExperimentalNot described
Receives: Behavioral: Eligibility reminder; Behavioral: Link to a broad set of vaccine venues
Boost intentions onlyExperimentalNot described
Receives: Behavioral: Eligibility reminder; Behavioral: Doctors' recommendation and value of vaccine
Boost intentions and facilitate action narrowlyExperimentalNot described
Receives: Behavioral: Eligibility reminder; Behavioral: Link to a narrow set of vaccine venues; Behavioral: Doctors' recommendation and value of vaccine
Boost intentions and facilitate action broadlyExperimentalNot described
Receives: Behavioral: Eligibility reminder; Behavioral: Link to a broad set of vaccine venues; Behavioral: Doctors' recommendation and value of vaccine
HoldoutNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. booster take-up in 2 weeks

    Whether people receive the bivalent booster at any location reporting to the California Immunization Registry (CAIR)

    Measured: 2 weeks after getting the text message

  2. booster take-up in 4 weeks

    Whether people receive the bivalent booster at any location reporting to CAIR

    Measured: 4 weeks after getting the text message

Secondary outcomes (3)
  1. booster take-up at UCLA/CVS in 2 weeks

    Whether people receive the bivalent booster at either UCLA Health or CVS

    Measured: 2 weeks after getting the text message

  2. booster take-up at UCLA/CVS in 4 weeks

    Whether people receive the bivalent booster at either UCLA Health or CVS

    Measured: 4 weeks after getting the text message

  3. Link click rate in 1 week

    Whether people click on at least one link provided in the text message

    Measured: 1 week after getting the text message

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2023

Resources

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
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
154,977 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586204
Sponsor's protocol ID
covidbooster1
Status last verified
Dec 2024
First submitted
17 Oct 2022
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.

    PubMed 33926993

Questions about this trial

What is this clinical trial studying?

A study testing Eligibility reminder, Link to a narrow set of vaccine venues and Link to a broad set of vaccine venues in people with COVID-19 and Vaccines, run by University of California, Los Angeles 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 4 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 9 Dec 2024. 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?

booster take-up in 2 weeks (time frame: 2 weeks after getting the text message). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586204, which also lists 1 linked publication.

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 9 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in