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

HPV Vaccine Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HPV Vaccine

• NCT number: NCT06227689
• Study type: Interventional
• Source: Fudan University
• Contact: Zhiyuan Hou, PhD
• Phone: 86+21 33563935
• Email: zyhou@fudan.edu.cn
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 22, 2024
• Completion date: April 22, 2024