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Fudan UniversityEvaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy 1,800 Vaccine Study Randomized Real-World Evidence
Clinical Trial NCT07200570 is an interventional study for HPV Vaccine and is currently not yet recruiting. Enrollment is planned to begin on September 26, 2025 and continue until the study accrues 1,800 participants. Led by Fudan University, this study is expected to complete by May 1, 2026. The latest data from ClinicalTrials.gov was last updated on October 1, 2025.
Brief Summary
The goal of this clinical trial is to learn if a chatbot powered by artificial intelligence works to improve HPV vaccination among females aged 15 to 26 in China. A randomized controlled trial and implementation science study will be conducted targeting females as participants. The main questions it aims to answer are:
- Does the vaccine chatbot influence women's confidence, literacy, hesitancy, and uptake of the H...
Detailed Description
A randomized controlled trial with 2 arms will be conducted to evaluate the effectiveness of an LLM-powered chatbot on improving HPV vaccination among females aged 15 to 26, followed by a pragmatic implementation science study to assess the public acceptance of chatbot and to identify the facilitators and barriers to its implementation in a real-world setting.
The sample size is calculated based on the primary outco...
Show MoreOfficial Title
Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy: a Randomized Controlled Trial and Implementation Science Study
Conditions
HPV VaccinePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- Fudan-HPV LLM chatbot
NCT ID Number
Start Date (Actual)
2025-09-26
Last Update Posted
2025-10-01
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
1,800
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
HPV
vaccine confidence
chatbot
randomised controlled trial
implementation science
vaccine confidence
chatbot
randomised controlled trial
implementation science
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalChatbot Intervention Group Participants in this arm will be granted access to an interactive, LLM-powered HPV vaccine chatbot for a period of three months. They are invited to use the chatbot to ask any questions related to HPV and HPV vaccine to receive personalized and accurate information. The chatbot invitation will be sent every weeks to reinforce the intervention within the first month. | LLM-Powered HPV Vaccine Chatbot A vaccine chatbot delivered via WeChat or a web browser, designed to provide information and health education about the HPV vaccine. The chatbot is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the WHO and China CDC to ensure accuracy. The knowledge base is validated by experts. The chatbot engages users in interactive, conversational ...Show More |
No InterventionControl Group Participants assigned to the control arm will receive standard care but will not have access to the HPV vaccine chatbot during the study period. For ethical considerations, participants in this arm will be offered access to the chatbot after the end of the study. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HPV Vaccine Uptake | Whether participants get vaccinated against HPV, measured by official vaccination records. | Three months after participant randomization allocation |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HPV Vaccine Hesitancy | HPV vaccine hesitancy will be measured using a 5-point Likert scale that assesses a participant's willingness to receive the HPV vaccine, with options ranging from "very willing" to "very unwilling". A higher score on the scale indicates higher hesitancy. | The same day after the intervention |
HPV Vaccine Confidence | Vaccine Confidence Index (VCI) that assesses confidence in the importance, effectiveness, and safety of vaccines using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). A higher score indicates greater confidence. | The same day after the intervention |
HPV Vaccine Literacy | A series of questions about HPV vaccine knowledge and misinformation. Total literacy score is calculated based on the number of questions answered correctly by the participants. | The same day after the intervention |
Timing of HPV Vaccination | When participants get vaccinated against HPV, measured by official vaccination records | Within three months after participant randomization allocation |
Chatbot Usability | A series of questions assessing usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot. | The same day after the intervention |
Cost of interventions | The cost of designing and implementing chatbot interventions. Unit of Measure: Chinese Yuan (CNY). | Within three months after participant randomization allocation |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
15 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- Female, aged 15 to 26 years, inclusive.
- Not previously vaccinated against HPV.
- Reports no contraindications to HPV vaccination.
- Has no mental, visual, or reading impairments that would preclude cooperation with study activities.
- Is willing and able to provide informed consent.
- Male.
- Age under 15 or over 26 years.
- Has a history of prior HPV vaccination.
- Has a known contraindication to HPV vaccination.
- Unable to comply with study procedures.
- Is unwilling or unable to provide informed consent.
Fudan University829 active studies to exploreMerck Sharp & Dohme LLC707 active studies to exploreStudy Responsible Party
Zhiyuan Hou, Principal Investigator, Associate Professor, Fudan University
Study Central Contact
Contact: Zhiyuan Hou, PhD, 86+21 54231112, [email protected]
No location data.