AzTrials
AzTrials

Influenza, HumanNCT07896850

Conversational AI for Adult Flu Vaccination Decisions

A study testing Flu vaccination guide and Accident safety guide in people with Influenza, Human and Vaccine Hesitancy, run by Calypta Systems, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized trial tests whether an online guide combining short evidence cards with an AI-guided conversation increases flu-vaccination intention among US adults who haven't decided whether to get a flu vaccine this season. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human, Vaccine Hesitancy
What is being tested?
Flu vaccination guide and Accident safety guide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteUnited States
Study dates
21 Oct 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • US resident, age 18 or older, Prolific approval rate ≥ 99% and at least 25 previous submissions
  • Answers "Probably", "Unsure", or "Probably not" to planning to get a flu vaccine in the next few months
  • Consents to participate

Who cannot join

  • Already vaccinated against flu this season ("Already done this year")
  • Baseline intention of 7 ("Definitely yes")
  • Took part in the feasibility pilot

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Calypta Systems, Inc.

    San Francisco, California, 94114

Other trials in United States

About this study

Official title: Conversational AI for Adult Flu Vaccination Decisions: An Active-Control Randomized Trial

This randomized trial tests whether an online guide combining short evidence cards with an AI-guided conversation increases flu-vaccination intention among US adults who haven't decided whether to get a flu vaccine this season. Participants recruited through Prolific are randomly assigned to the flu guide or to a structure-matched guide about everyday accident safety. The primary outcome is self-rated likelihood of getting a flu vaccine this season (1-7), asked immediately after the session. Participants are asked at about 2 and 8 weeks whether they have been vaccinated. The study is powered for the intention outcome but not for vaccination. For vaccination, it estimates the effect, the base rate, and follow-up response, to size a later, larger trial.

Read the detailed description

In a prior randomized trial by the same investigator, a similar intervention (evidence cards followed by an AI-guided motivational-interviewing conversation) raised MMR vaccination intention among hesitant parents by about one point on a 1-7 scale relative to an active control (Forman 2025, PsyArXiv, doi:10.31234/osf.io/5kteh_v1). This study tests whether the effect transfers to a different decision and population: adult seasonal flu vaccination.

Design: two-arm, parallel, 1:1 randomized trial conducted entirely online. Participants are US adults on Prolific (approval rate ≥ 99%, at least 25 previous submissions), desktop or mobile. A five-item health-plans screener masks the eligibility question; eligible participants answer "Probably", "Unsure", or "Probably not" to getting a flu vaccine in the next few months. Participants then answer the baseline intention item; those answering 7 are screened out before randomization. Randomization is by minimization within screener stratum (probably / unsure / probably not), with random tie-breaking. Up to 220 are randomized; dropouts are not replaced.

Intervention: a study version of Calypta Health's public flu vaccination guide: an intro card and 12 evidence cards (including an interactive simulation), followed by a conversation with an AI model (a Claude model accessed through Amazon Bedrock; the model and its instructions are fixed for the study's duration). Control: a study-only guide on everyday accident avoidance (mostly driving, plus falls and smoke and carbon-monoxide alarms) with the same structure, card count, minimum reading time, and conversation rules. In both arms, per-card minimum times (10 seconds for the intro card, 20 seconds for each other card) and a minimum conversation length (at least 3 rounds and 100 engagement points) apply. After the post-session question, participants in either arm who answer 6 or 7 are offered the same optional flu-vaccination plan card (where and which day). Because the card is offered only after a 6 or 7, more flu-arm participants may see it, so the vaccination comparison includes any effect of the card.

Follow-up: check-ins at about 2 and 8 weeks, each a separate Prolific study open to everyone randomized, ask about flu vaccination since the session, intention, and (as a negative-control outcome) dental cleanings or checkups.

Analysis: the primary outcome is analyzed by ANCOVA adjusting for baseline intention and screener stratum, with HC3 standard errors, two-sided α = .05. The analysis set is randomized participants who completed the session and met the engagement rule; the primary population excludes sessions that an AI reviewer links as one person using two accounts, sensitivity analyses include everyone or remove sessions flagged as low quality, and a further analysis is limited to participants with a baseline intention of 5 or below. Analysis code for the primary outcome is written and frozen before arm labels are unblinded; check-in outcomes are analyzed as the preregistered plan specifies once each wave closes, with any deviation reported. A full analysis plan is preregistered on OSF and linked from this record.

A feasibility pilot (20 randomized, 2026-10-15), under the same IRB approval, preceded main enrollment to test study mechanics and a next-day follow-up; pilot data are not presented as results of this study or combined with main-study data, and pilot participants are excluded from the main study.

Conflict of interest: the investigator founded Calypta Systems, Inc. and is its CEO, sole director, and majority shareholder. Calypta makes the flu guide and funds the study. Results will be made public regardless of outcome.

Being tested
Flu vaccination guide, Accident safety guide
Keywords
influenza vaccination, vaccine hesitancy, motivational interviewing, large language model, conversational agent, chatbot, health decision-making
Medical subject headings
Influenza, Human, Vaccination Hesitancy

What participants receive

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

  • Flu vaccination guideBehavioural

    Online guide with 12 evidence cards on seasonal flu and flu vaccines (including an interactive simulation of flu risk), with per-card minimum reading times, followed by a text or voice conversation with an AI model instructed to use motivational-interviewing techniques and to draw on curated, cited sources. The session takes about 10 to 20 minutes.

  • Accident safety guideBehavioural

    Online guide with 12 evidence cards on everyday accident avoidance (driving, falls, and smoke and carbon-monoxide alarms; including an interactive seatbelt simulation), with matched minimum reading time, followed by an AI conversation under the same rules. The session takes about 10 to 20 minutes.

Study groups in NCT07896850
Study groupRoleWhat they receive
Flu vaccination guideExperimentalCalypta Health's flu vaccination guide: 12 evidence cards followed by an AI-guided conversation.
Receives: Behavioral: Flu vaccination guide
Accident safety guideSham comparatorAn attention-matched control: a structure-matched guide on everyday accident avoidance, 12 evidence cards followed by an AI-guided conversation, with no flu or vaccine content.
Receives: Behavioral: Accident safety guide

What is being measured

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

  1. Flu vaccination intention

    "How likely are you to get a flu vaccine this season?" 1 (Definitely not) to 7 (Definitely yes), asked identically at baseline and post-session. Analyzed as the post-session score adjusted for baseline and stratum.

    Measured: Immediately after the session (about 10 to 20 minutes after baseline)

Secondary outcomes (3)
  1. Self-reported flu vaccination

    Proportion of check-in B respondents who answered "Yes, I've gotten a flu vaccine" at either check-in (about 2 or about 8 weeks) to "Since you took part in our study on [the participant's session date, e.g. October 15], have you gotten a flu vaccine?"

    Measured: About 8 weeks after the session

  2. Flu vaccination intention or vaccination at 2 weeks

    The 1-7 intention item at the check-in, with participants vaccinated by that check-in coded 7, adjusted for baseline and stratum.

    Measured: About 2 weeks after the session

  3. Flu vaccination intention or vaccination at 8 weeks

    As above, at check-in B, where vaccinated means a yes at either check-in.

    Measured: About 8 weeks after the session

Timeline

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

  1. First posted27 Oct 2026
  2. Study start21 Oct 2026
  3. Primary completion21 Oct 2026
  4. Study completion31 Dec 2026 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896850
Sponsor's protocol ID
CALYPTA-FLU-1
Other IDs
HIRB 101226-1441
Status last verified
Nov 2026
First submitted
20 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified structured variables only (screener answers, intention measures, arm, stratum, engagement counts, check-in answers, and the coarse demographic and device groups used in the analyses by group) under study codes. Not shared: Prolific IDs, conversation transcripts.

Publications

  • Forman SJ. Informational Briefing Followed by LLM-Guided Motivational Interview Increases MMR Vaccination Intent among Hesitant Parents. PsyArXiv preprint, 2025. doi:10.31234/osf.io/5kteh_v1

Questions about this trial

What is this clinical trial studying?

A study testing Flu vaccination guide and Accident safety guide in people with Influenza, Human and Vaccine Hesitancy, run by Calypta Systems, Inc. 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Flu vaccination intention (time frame: Immediately after the session (about 10 to 20 minutes after baseline)). 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 NCT07896850, 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 4 Nov 2026.

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