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.
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
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- 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
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.
- Conditions
- Influenza, Human, Vaccine Hesitancy
- 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 group | Role | What they receive |
|---|---|---|
| Flu vaccination guide | Experimental | Calypta Health's flu vaccination guide: 12 evidence cards followed by an AI-guided conversation. Receives: Behavioral: Flu vaccination guide |
| Accident safety guide | Sham comparator | An 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.
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)
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
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
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.
- First posted27 Oct 2026
- Study start21 Oct 2026
- Primary completion21 Oct 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calypta Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott J Forman, Principal investigator, Calypta Systems, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversational AI for Adult Flu Vaccination Decisions: An Active-Control Randomized Trial
- ClinicalTrials.gov ID
- NCT07896850
- Acronym / sponsor ID
- CALYPTA-FLU-1
- Conditions
- Influenza, Human, Vaccine Hesitancy
- Keywords
- influenza vaccination, vaccine hesitancy, motivational interviewing, large language model, conversational agent, chatbot, health decision-making
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Calypta Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flu vaccination guide | Experimental | Behavioral: Flu vaccination guideCalypta Health's flu vaccination guide: 12 evidence cards followed by an AI-guided conversation. |
| Accident safety guide | Sham comparator | Behavioral: Accident safety guideAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Already vaccinated against flu this season ("Already done this year")
- Baseline intention of 7 ("Definitely yes")
- Took part in the feasibility pilot
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 |
|---|---|---|
| Flu vaccination guideOnline 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. | Behavioural | Flu vaccination guide |
| Accident safety guideOnline 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. | Behavioural | Accident safety guide |
Primary outcome
Flu vaccination intention
Time frame: Immediately after the session (about 10 to 20 minutes after baseline)
"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.
3 secondary outcomes
Self-reported flu vaccination
Time frame: About 8 weeks after the session
Flu vaccination intention or vaccination at 2 weeks
Time frame: About 2 weeks after the session
Flu vaccination intention or vaccination at 8 weeks
Time frame: About 8 weeks after the session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundForman 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
- Preregistration and statistical analysis plan (OSF)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Scott J Forman principal investigator
Calypta Systems, Inc.
1 site in 1 country: see every site and its status.
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.