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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Fudan University | The University of Hong Kong |
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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 all — Click here to view all references
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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