Effectiveness of Large Language Model-Based Chatbot Among Female University Stdents in Improving HPV Vaccine Awareness, Intention and Vaccination Rates

March 25, 2026 updated by: Jun Zhang, Xiamen University

A Study on the Effectiveness of Large Language Model-Based Chatbot Interventions Among Female University Stdents in Improving HPV Vaccine Awareness, Intention and Vaccination Rates

This is an interventional study targeting female university students. The primary objective of the study is to evaluate the effectiveness of a vaccine chatbot in improving HPV vaccination rates. The secondary objectives are to evaluate the effectiveness in improving vaccine awareness and vaccination intention. All participants will be enrolled and randomly assigned to four groups: (1) vaccine chatbot plus scientific videos, (2) vaccine chatbot only, (3) scientific videos only, and (4) a control group (no intervention). The chatbot will provide immediate, validated answers to participants' HPV vaccine-related questions. The scientific videos will cover content related to HPV vaccine safety, efficacy, and other relevant information. The study will compare changes in HPV vaccine awareness, vaccination intention, and vaccination behavior between the intervention groups and the control group after the intervention to evaluate whether the three intervention strategies enhance HPV vaccine awareness, vaccination intention, and vaccination uptake.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female university students.
  2. Possess an electronic device with QR code scanning capability.
  3. Female university students have no contraindications to HPV vaccination.
  4. No mental disorders or visual/reading impairments; able to cooperate with and implement the corresponding intervention activities.
  5. Have provided informed consent and are willing to participate in the study.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
No intervention
Experimental: Vaccine chatbot + Watching scientific videos group
The chatbot will provide immediate, validated answers to participants' HPV vaccine-related questions. Scientific videos cover content related to HPV vaccine safety, efficacy, and other relevant information.
Device: Scientific videos
Provide scientific videos related to HPV vaccine
Device: Vaccine chatbot
Provide vaccine chatbot to answer HPV vaccine questions
Experimental: Watching scientific videos group
Scientific videos cover content related to HPV vaccine safety, efficacy, and other relevant information.
Device: Scientific videos
Provide scientific videos related to HPV vaccine
Experimental: Vaccine chatbot group
The chatbot will provide immediate, validated answers to participants' HPV vaccine-related questions.
Device: Vaccine chatbot
Provide vaccine chatbot to answer HPV vaccine questions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HPV vaccination rates for female university students in all groups before and after the intervention
Time Frame: Baseline and two months
Whether female university students get vaccinated against HPV or have an appointment for vaccination, measured by self-report and validated by vaccination information system
Baseline and two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HPV vaccine awareness for eligible female university students in all groups before and after the intervention
Time Frame: Baseline and two weeks
A questionnaire consisting of 11 questions related to HPV vaccines will be used to investigate the awareness of HPV vaccines.Total knowledge score is calculated based on the number of questions answered correctly by the participants and the higher scores mean a better outcome.
Baseline and two weeks
HPV vaccination intention for eligible female university students in all groups before and after the intervention
Time Frame: Baseline and two weeks
Female university students' willingness to vaccinate themselves, measured using a five-point Likert scale from "not willing at all" to "strongly willing"
Baseline and two weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vaccine chatbot acceptability and implementability
Time Frame: Two weeks
A questionnaire consisting of 10 questions assessing usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot, measured using a five-point Likert scale from "not willing at all" to "strongly willing"
Two weeks
Factors influencing vaccination intention for eligible female university students
Time Frame: Two weeks and six months
Survey items: age, education level, marital status, occupation, annual income, and awareness of vaccines.
Two weeks and six months
HPV vaccination rates for female university students in all groups after the intervention
Time Frame: two weeks, one month and six months
Whether female university students get vaccinated against HPV or have an appointment for vaccination, measured by self-report and validated by vaccination information system
two weeks, one month and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xiamen Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPV-AI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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