Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy

NCT07200570 | Not Yet Recruiting DMC

• 1 other identifier: Fudan-HPV LLM chatbot
• Study Type: interventional
• Target: 1,800
• Locations: 0 countries
• Sites: N/A

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:

1. 1.Does the vaccine chatbot influence women's confidence, literacy, hesitancy, and uptake of the HPV vaccine.
2. 2.What are the public acceptance of chatbot and the facilitators and barriers to its implementation in a real-world setting.
3. 3.Be recruited and randomly allocated into one of two groups. One group will be invited to use the HPV vaccine chatbot and the other group will not get access to the vaccine chatbot until the end of the trial.
4. 4.Complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine.
5. 5.Have their vaccination status checked at the end of trial.

Conditions

HPV Vaccine

Keywords

HPV; vaccine confidence; chatbot; randomised controlled trial; implementation science

Outcome Measures

Primary Outcomes (1)

• HPV Vaccine Uptake

  Whether participants get vaccinated against HPV, measured by official vaccination records.

  Three months after participant randomization allocation

Secondary Outcomes (6)

• HPV Vaccine Hesitancy

  The same day after the intervention

• HPV Vaccine Confidence

  The same day after the intervention

• HPV Vaccine Literacy

  The same day after the intervention

• Timing of HPV Vaccination

  Within three months after participant randomization allocation

• Chatbot Usability

  The same day after the intervention

Study Arms (2)

Chatbot Intervention Group

EXPERIMENTAL

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.

Behavioral: LLM-Powered HPV Vaccine Chatbot

Control Group

NO INTERVENTION

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.

Interventions

LLM-Powered HPV Vaccine Chatbot BEHAVIORAL

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 dialogue to answer questions and address concerns regarding HPV and HPV vaccines.

Chatbot Intervention Group

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (20)

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Central Study Contacts

Zhiyuan Hou, PhD

CONTACT

86+21 54231112; zyhou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 26, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share