Effectiveness of Vaccine Chatbot on HPV Vaccine Awareness and Vaccination in China

January 26, 2024 updated by: Zhiyuan Hou, Fudan University

Evaluation of Vaccine Chatbot on HPV Vaccine Awareness and Vaccination for Middle School Girls in China: a Randomized Controlled Trial and Implementation Science Study

This interventional study targets female students in junior middle school. It goal is to evaluate the effectiveness of a vaccine chatbot on HPV vaccine awareness and vaccination. The main questions it aims to answer are:

  1. How will the novel digital tool, a vaccine chatbot, impact eligible parents' awareness and knowledge of HPV vaccines, their willingness to vaccinate their daughters, and vaccination status of female students.
  2. How is the vaccine chatbots accepted by all stakeholders, and what are the facilitators of and barriers to implementing vaccine chatbot promotion campaign.

The intervention group will go through the intervention measure while the control group will not:

  1. The intervention group will be invited to use the HPV vaccine chatbot online through WeChat , the mostly widely used social media platform in mainland China, or any web browsers. They can ask any questions related to the HPV vaccine and get validated answers from the chatbot immediately. The intervention lasts two weeks, with invitations sent every four days to reinforce the intervention.
  2. The control group will not use the chatbot during the intervention duration.

Researchers will compare participants' HPV vaccine awareness, and vaccination intention and status after intervention between intervention group and control group to evaluate if the vaccine chatbot improves HPV vaccine awareness and vaccination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a cluster randomized trial consisted of 2 arms to evaluate the effectiveness of a vaccine chatbot on parents' HPV vaccine awareness, knowledge, and vaccination intention and status regarding their daughters in junior middle school.

The sample size was calculated based on two main outcome indicators (parents' willingness to vaccinate, and vaccination rate of female students) and the main analysis method (comparison of differences in rates or means before and after the intervention). 1) According to the literature review, the willingness of Chinese parents to vaccinate their children against HPV is 50%-70%, and the investigators assumed that the willingness to vaccinate was 60% before the intervention and could be increased to 70% after the intervention. The minimum sample size was calculated to be 530 participants in each group, with significance level (α) at 0.05, test power (1-β) of 0.8, and the cluster design effect (D) of 1.5. 2) The current HPV vaccination rate of female students is around 5%, and the investigators assumed that the vaccination rate could increase to 10%-12% after the intervention. The minimum sample size was calculated to be 369-648 participants in each group, with significance level (α) at 0.05, test power (1-β) of 0.8, and the cluster design effect (D) of 1.5.

Multi-stage sampling will be employed. Firstly, three representative cities will be selected to represent the megacity, general urban city, and rural counties in China, respectively. Then, within each city, three or four middle schools will be selected based on economic development, school size, geographical location. Next, around six classes will be randomly selected for each of the three grades in each middle school. For all the female students who have not be vaccinated against HPV in selected classes, one of their parents will be included in the study. A total of around 162 classes are expected to be included, with around 54 classes in each city.

Stratified cluster randomized grouping will be employed. All classes will be grouped into intervention group or control group by class at a 1:1 ratio, stratified by city, school, and grades, resulting with around 81 classes into the intervention group and 81 in control group. Approximately 600 parents (300 in intervention group; 300 in control group) are expected to participate in the study in each city, with a total sample size of 1,800 parents, meeting the sample size requirement.

Baseline survey will be conducted before the intervention. Then, the intervention group will be invited to use the HPV vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the HPV vaccine and get validated answers from the chatbot immediately. The intervention lasts two weeks, with invitations sent every four days to reinforce the intervention. The control group will not use the chatbot during the intervention duration. After 2 weeks, follow-up survey will then be conducted. HPV vaccination status of female students will be collected after 1.5 months and 3 months.

The Difference-in-Differences (DID) method will be utilized to adjust and reduce the effects of other covariates, aiming to evaluate the intervention effect of the chatbot.

Besides impact evaluation, this study will also conduct an implementation science study, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to comprehensively assess the cost-effectiveness, applicability, and scalability of the HPV vaccine chatbot intervention in real-world. Both quantitative and qualitative methods will be used to evaluate its implementation across the above-mentioned five dimensions: reach, effectiveness, adoption, implementation, and maintenance.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Chizhou, Anhui, China, 247100
        • Chizhou Health Center for Disease Control and Prevention
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents of female students in middle school;
  • The students not vaccinated or appointed for HPV vaccination and without contraindications to HPV vaccines;
  • Without mental disorders or visual/reading impairments, and able to cooperate with and undergo the intervention activities;
  • Obtained informed consent and willing to participate in the study.

Exclusion Criteria:

  • Students vaccinated or appointed for HPV vaccination or with any contraindication to HPV vaccines;
  • With mental disorders or visual/reading impairments, and unable to cooperate with and undergo the intervention activities;
  • Unwilling to participate.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPV Chatbot Intervention group
In this arm, participants will receive a vaccine chatbot intervention. They will be invited to use the HPV vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the HPV vaccine and get immediate answers from the chatbot. The intervention lasts two weeks, with invitations sent every four days to reinforce the intervention.
Other: Vaccine chatbot that offering HPV vaccine-related information
The intervention group will be invited to use the HPV vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the HPV vaccine and get previously validated answers from the chatbot immediately. All the answers will be drawn from a database, whose content were obtained from official websites of Chinese government, HPV vaccine enterprises, and International organizations like WHO, and had been validated by experts. The intervention lasts two weeks, with invitations sent every four days to reinforce the intervention.
No Intervention: Control group
The control group will not use the chatbot during the intervention duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccination intention
Time Frame: Two weeks between baseline and follow-up surveys
Parents' willingness to vaccinate their daughters against HPV, measured using a five-point Likert scale from "very unwilling" to "very willing"
Two weeks between baseline and follow-up surveys
HPV vaccination status and appointment
Time Frame: 1.5 and 3 months following baseline survey
whether participants' daughters get vaccinated against HPV or have an appointment for vaccination, measured by self-report and validated by vaccination information system
1.5 and 3 months following baseline survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccine awareness and knowledge
Time Frame: Two weeks between baseline and follow-up surveys
10 questions about HPV vaccine knowledge and misinformation. Total knowledge score is calculated based on the number of questions answered correctly by the participants.
Two weeks between baseline and follow-up surveys
HPV vaccine confidence
Time Frame: Two weeks between baseline and follow-up surveys
Vaccine Confidence Index (VCI), including confidence on vaccine importance, effectiveness and safety
Two weeks between baseline and follow-up surveys
Vaccination delay
Time Frame: Two weeks between baseline and follow-up surveys
Whether parents will wait for 9-valent vaccine and delay vaccinating daughter when supply of the 9-valent vaccine runs low
Two weeks between baseline and follow-up surveys
Chatbot Usability
Time Frame: Two weeks after the follow-up survey
Chatbot Usability Questionnaire (CUQ) designed by the Ulster University, measuring Chatbot Personality, Onboarding, User Experience, Error Handling, and so on
Two weeks after the follow-up survey

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Zhiyuan Hou, PhD, School of Public Health，Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 22, 2024

Primary Completion (Estimated)

February 22, 2024

Study Completion (Estimated)

April 22, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FudanU-HPV Chatbot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices), will be shared upon reasonable requests. A written data-sharing request for meta-analysis should be submitted by email with a methodologically sound proposal. Proposals should be directed to zyhou@fudan.edu.cn; to gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Beginning 12 months and ending 36 months following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal for meta-analysis. Proposals should be directed to zyhou@fudan.edu.cn; to gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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