NCT06227689

Brief 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. 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. 2.How is the vaccine chatbots accepted by all stakeholders, and what are the facilitators of and barriers to implementing vaccine chatbot promotion campaign.
  3. 3.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.
  4. 4.The control group will not use the chatbot during the intervention duration.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

January 18, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

HPV vaccineawarenessknowledgevaccinationvaccine confidence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Willingness to vaccinate

    Two weeks between baseline and follow-up surveys

  • HPV vaccine awareness and knowledge

    Two weeks between baseline and follow-up surveys

  • HPV vaccine confidence

    Two weeks between baseline and follow-up surveys

  • Healthcare consultation

    Two weeks after the baseline

  • Chatbot Usability

    Two weeks after the baseline

Study Arms (2)

HPV Chatbot Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will not use the chatbot during the intervention duration.

Interventions

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 Chatbot Intervention group

Eligibility Criteria

Age10 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chizhou Health Center for Disease Control and Prevention

Chizhou, Anhui, 247100, China

RECRUITING

Jiading District Center for Disease Control and Prevention

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (24)

  • 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 vaccine roll-out in mainland China. Vaccine. 2021 Jan 3;39(1):35-44. doi: 10.1016/j.vaccine.2020.11.029. Epub 2020 Nov 23.

  • 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 register-based observational study. Lancet. 2021 Dec 4;398(10316):2084-2092. doi: 10.1016/S0140-6736(21)02178-4. Epub 2021 Nov 3.

  • 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 10;394(10197):497-509. doi: 10.1016/S0140-6736(19)30298-3. Epub 2019 Jun 26.

  • 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(9):e484-e492. doi: 10.1016/S2468-2667(20)30139-0. Epub 2020 Jul 21.

  • 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.

  • 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/s12889-016-2873-8.

  • 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: 10.1080/21645515.2021.1951931. Epub 2021 Jul 29.

  • 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.

  • 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: 10.1080/21645515.2020.1812314. Epub 2020 Oct 29.

  • 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-center intervention follow-up study. Vaccine. 2020 Apr 29;38(20):3665-3670. doi: 10.1016/j.vaccine.2020.03.032. Epub 2020 Mar 31.

  • 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):e13566. doi: 10.1111/ecc.13566. Epub 2022 Mar 1.

  • 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;29:10732748211070719. doi: 10.1177/10732748211070719.

  • 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-Behavioral Skills Model in a Cluster Randomized Trial. J Med Internet Res. 2022 Sep 30;24(9):e37848. doi: 10.2196/37848.

  • 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.

  • 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 Singapore. NPJ Digit Med. 2023 May 25;6(1):96. doi: 10.1038/s41746-023-00843-6.

  • 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.

  • 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.

  • 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. 2022 Jul 30;40(32):4654-4662. doi: 10.1016/j.vaccine.2022.06.007. Epub 2022 Jun 8.

  • 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 Communities: Qualitative Study. J Med Internet Res. 2022 Jul 6;24(7):e38418. doi: 10.2196/38418.

  • 宋祎凡,刘晓雪,尹遵栋,等.2018-2020年中国9-45岁女性人乳头瘤病毒疫苗估算接种率[J].中国疫苗和免疫,2021,27(05):570-575.

    RESULT
  • 邱丽蓉,牛战琴.9~14岁女性人乳头瘤病毒疫苗接种现状及其影响因素分析[J].中国生育健康杂志,2022,33(03):262-265.

    RESULT
  • 史金晶,张肖肖,郑徽,等.中国大陆青少年家长人乳头瘤病毒疫苗认知度和接受度Meta分析[J].中国疫苗和免疫,2019,25(04):464-470.

    RESULT
  • 武丽,马远珠,黄雪萍,等.广东省青少年女性对HPV疫苗知晓及接种意愿的调查研究[J].中国妇幼卫生杂志,2021,12(05):19-23.

    RESULT
  • Hou Z, Wu Z, Qu Z, Gong L, Peng H, Jit M, Larson HJ, Wu JT, Lin L. A vaccine chatbot intervention for parents to improve HPV vaccination uptake among middle school girls: a cluster randomized trial. Nat Med. 2025 Jun;31(6):1855-1862. doi: 10.1038/s41591-025-03618-6. Epub 2025 Apr 7.

Related Links

Study Officials

  • Zhiyuan Hou, PhD

    School of Public Health,Fudan University

    PRINCIPAL INVESTIGATOR
  • Leesa Lin, PhD

    School of Public Health, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyuan Hou, PhD

CONTACT

Leesa Lin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

January 18, 2024

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 12 months and ending 36 months following article publication
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.

Locations