- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351604
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
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
18000
Phase
- 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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female university students.
- Possess an electronic device with QR code scanning capability.
- Female university students have no contraindications to HPV vaccination.
- No mental disorders or visual/reading impairments; able to cooperate with and implement the corresponding intervention activities.
- 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 |
Intervention / Treatment |
|---|---|
|
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.
|
Provide scientific videos related to HPV vaccine
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.
|
Provide scientific videos related to HPV vaccine
|
|
Experimental: Vaccine chatbot group
The chatbot will provide immediate, validated answers to participants' HPV vaccine-related questions.
|
Provide vaccine chatbot to answer HPV vaccine questions
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Collaborators
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)
April 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
December 25, 2025
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID 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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