An interventional study of Vaccine chatbot that offering HPV vaccine-related information in HPV Vaccine, sponsored by Fudan University. Recruiting at 2 sites in China. Open to female participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Fudan University · Not applicable, Interventional, and Health services research
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:
The intervention group will go through the intervention measure while the control group will not:
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.
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 the primary outcome, which is the HPV vaccination rate among middle school girls, and the main analysis method, which involves comparing differences in rates or means before and after the intervention. According to a literature review, the current HPV vaccination rate among female students is around 5%. The investigators assumed that the vaccination rate could increase to between 10% and 12% following the intervention. The minimum sample size was calculated to be between 369 and 648 participants in each group, with a significance level (α) of 0.05, a test power (1-β) of 0.8, and a 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 4 months.
The Generalized Estimating Equations (GEE) and mixed-effects analysis methods were employed to control for the effects of covariates and 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.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 control group will not use the chatbot during the intervention duration.
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.
HPV vaccination status and appointment
whether participants' daughters get vaccinated against HPV or have an appointment for vaccination, measured by self-report and validated by vaccination information system
Time frame: Two weeks and four months after the baseline
Willingness to vaccinate
Parents' willingness to vaccinate their daughters against HPV, measured using a five-point Likert scale from "very unwilling" to "very willing"
Time frame: Two weeks between baseline and follow-up surveys
HPV vaccine awareness and knowledge
10 questions about HPV vaccine knowledge and misinformation. Total knowledge score is calculated based on the number of questions answered correctly by the participants.
Time frame: Two weeks between baseline and follow-up surveys
HPV vaccine confidence
Vaccine Confidence Index (VCI), including confidence on vaccine importance, effectiveness and safety
Time frame: Two weeks between baseline and follow-up surveys
Healthcare consultation
Assessment of parental engagement in seeking medical advice about vaccinating their daughter with the HPV vaccine during the two weeks leading up to the follow-up survey.
Time frame: Two weeks after the baseline
Chatbot Usability
17 questions assessing usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot.
Time frame: Two weeks after the baseline
Plan to share: Yes — 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.
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fudan University