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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06227689
Other study ID # FudanU-HPV Chatbot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2024
Est. completion date July 31, 2024

Study information

Verified date June 2024
Source Fudan University
Contact Zhiyuan Hou, PhD
Phone 86+21 33563935
Email zyhou@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

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.


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
China Chizhou Health Center for Disease Control and Prevention Chizhou Anhui
China Jiading District Center for Disease Control and Prevention Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Fudan University The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (23)

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Almalki M, Azeez F. Health Chatbots for Fighting COVID-19: a Scoping Review. Acta Inform Med. 2020 Dec;28(4):241-247. doi: 10.5455/aim.2020.28.241-247. — View Citation

Drolet M, Benard E, Perez N, Brisson M; HPV Vaccination Impact Study Group. Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis. Lancet. 2019 Aug 1 — View Citation

Falcaro M, Castanon A, Ndlela B, Checchi M, Soldan K, Lopez-Bernal J, Elliss-Brookes L, Sasieni P. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a registe — View Citation

Hu S, Xu X, Zhang Y, Liu Y, Yang C, Wang Y, Wang Y, Yu Y, Hong Y, Zhang X, Bian R, Cao X, Xu L, Zhao F. A nationwide post-marketing survey of knowledge, attitude and practice toward human papillomavirus vaccine in general population: Implications for vacc — View Citation

Kobayashi T, Nishina Y, Tomoi H, Harada K, Tanaka K, Matsumoto E, Horimukai K, Ishihara J, Sasaki S, Inaba K, Seguchi K, Takahashi H, Salinas JL, Yamada Y. Corowa-kun: A messenger app chatbot delivers COVID-19 vaccine information, Japan 2021. Vaccine. 202 — View Citation

Lee KY, Dabak SV, Kong VH, Park M, Kwok SLL, Silzle M, Rachatan C, Cook A, Passanante A, Pertwee E, Wu Z, Elkin JA, Larson HJ, Lau EHY, Leung K, Wu JT, Lin L. Effectiveness of chatbots on COVID vaccine confidence and acceptance in Thailand, Hong Kong, and — View Citation

Luk TT, Lui JHT, Wang MP. Efficacy, Usability, and Acceptability of a Chatbot for Promoting COVID-19 Vaccination in Unvaccinated or Booster-Hesitant Young Adults: Pre-Post Pilot Study. J Med Internet Res. 2022 Oct 4;24(10):e39063. doi: 10.2196/39063. — View Citation

Si M, Su X, Jiang Y, Wang W, Zhang X, Gu X, Ma L, Li J, Zhang S, Ren Z, Liu Y, Qiao Y. An Internet-Based Education Program for Human Papillomavirus Vaccination Among Female College Students in Mainland China: Application of the Information-Motivation-Beha — View Citation

Si M, Su X, Jiang Y, Wang W, Zhang X, Gu X, Ma L, Li J, Zhang S, Ren Z, Liu Y, Qiao Y. Effect of an IMB Model-Based Education on the Acceptability of HPV Vaccination Among College Girls in Mainland China: A Cluster RCT. Cancer Control. 2022 Jan-Dec;29:107 — View Citation

Sonawane K, Zhu Y, Montealegre JR, Lairson DR, Bauer C, McGee LU, Giuliano AR, Deshmukh AA. Parental intent to initiate and complete the human papillomavirus vaccine series in the USA: a nationwide, cross-sectional survey. Lancet Public Health. 2020 Sep;5 — View Citation

Wang D, Wu J, Du J, Ong H, Tang B, Dozier M, Weller D, Campbell C. Acceptability of and barriers to human papillomavirus vaccination in China: A systematic review of the Chinese and English scientific literature. Eur J Cancer Care (Engl). 2022 May;31(3):e — View Citation

Weeks R, Cooper L, Sangha P, Sedoc J, White S, Toledo A, Gretz S, Lahav D, Martin N, Michel A, Lee JH, Slonim N, Bar-Zeev N. Chatbot-Delivered COVID-19 Vaccine Communication Message Preferences of Young Adults and Public Health Workers in Urban American C — View Citation

Wei Z, Liu Y, Zhang L, Sun X, Jiang Q, Li Z, Wu Y, Fu C. Stages of HPV Vaccine Hesitancy Among Guardians of Female Secondary School Students in China. J Adolesc Health. 2023 Jan;72(1):73-79. doi: 10.1016/j.jadohealth.2022.08.027. Epub 2022 Oct 11. — View Citation

Wilson L, Marasoiu M. The Development and Use of Chatbots in Public Health: Scoping Review. JMIR Hum Factors. 2022 Oct 5;9(4):e35882. doi: 10.2196/35882. — View Citation

Xie Y, Su LY, Wang F, Tang HY, Yang QG, Liu YJ. Awareness regarding and vaccines acceptability of human papillomavirus among parents of middle school students in Zunyi, Southwest China. Hum Vaccin Immunother. 2021 Nov 2;17(11):4406-4411. doi: 10.1080/2164 — View Citation

Zang S, Zhang X, Qu Z, Chen X, Hou Z. Promote COVID-19 Vaccination for Older Adults in China. China CDC Wkly. 2022 Sep 16;4(37):832-834. doi: 10.46234/ccdcw2022.173. No abstract available. — View Citation

Zhang X, Liu CR, Wang ZZ, Ren ZF, Feng XX, Ma W, Gao XH, Zhang R, Brown MD, Qiao YL, Geng Q, Li J. Effect of a school-based educational intervention on HPV and HPV vaccine knowledge and willingness to be vaccinated among Chinese adolescents : a multi-cent — View Citation

Zhang X, Wang Z, Ren Z, Li Z, Ma W, Gao X, Zhang R, Qiao Y, Li J. HPV vaccine acceptability and willingness-related factors among Chinese adolescents: a nation-wide study. Hum Vaccin Immunother. 2021 Apr 3;17(4):1025-1032. doi: 10.1080/21645515.2020.18123 — View Citation

Zhang Y, Wang Y, Liu L, Fan Y, Liu Z, Wang Y, Nie S. Awareness and knowledge about human papillomavirus vaccination and its acceptance in China: a meta-analysis of 58 observational studies. BMC Public Health. 2016 Mar 3;16:216. doi: 10.1186/s12889-016-287 — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Two weeks and four months after the baseline
Secondary Willingness to vaccinate 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
Secondary 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. Two weeks between baseline and follow-up surveys
Secondary HPV vaccine confidence Vaccine Confidence Index (VCI), including confidence on vaccine importance, effectiveness and safety Two weeks between baseline and follow-up surveys
Secondary 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. Two weeks after the baseline
Secondary Chatbot Usability 17 questions assessing usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot. Two weeks after the baseline
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