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HPV VaccineNCT06227689

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

A study testing Vaccine chatbot that offering HPV vaccine-related information in people with HPV Vaccine, run by Fudan University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 16 years, women onlyHealthy volunteers can take part
Conditions the study is for
HPV Vaccine
What is being tested?
Vaccine chatbot that offering HPV vaccine-related information
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
2 sitesChina
Study dates
18 Jan 2024to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Zhiyuan Hou, PhD contact

86+21 33563935

zyhou@fudan.edu.cn

Leesa Lin, PhD contact

+852 39103770

leesalin@hku.hk

China2 sites, 2 recruiting

  • Chizhou Health Center for Disease Control and Prevention

    Chizhou, Anhui, 247100

    Liuing Gong, MS, chzcpdcxf@126.com

    Recruiting

  • Jiading District Center for Disease Control and Prevention

    Shanghai, Shanghai Municipality

    Hui Peng, MS, penny200210108@sina.com

    Recruiting

Other trials in China

About this study

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.
Read more

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.

Read the detailed 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.

Conditions
HPV Vaccine
Being tested
Vaccine chatbot that offering HPV vaccine-related information
Keywords
HPV vaccine, awareness, knowledge, vaccination, vaccine confidence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine chatbot that offering HPV vaccine-related informationOther

    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.

Study groups in NCT06227689
Study groupRoleWhat they receive
HPV Chatbot Intervention groupExperimentalIn 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.
Receives: Other: Vaccine chatbot that offering HPV vaccine-related information
Control groupNo interventionThe control group will not use the chatbot during the intervention duration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Two weeks and four months after the baseline

Secondary outcomes (5)

  1. Willingness to vaccinate

    Parents' willingness to vaccinate their daughters against HPV, measured using a five-point Likert scale from "very unwilling" to "very willing"

    Measured: Two weeks between baseline and follow-up surveys

  2. 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.

    Measured: Two weeks between baseline and follow-up surveys

  3. HPV vaccine confidence

    Vaccine Confidence Index (VCI), including confidence on vaccine importance, effectiveness and safety

    Measured: Two weeks between baseline and follow-up surveys

  4. 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.

    Measured: Two weeks after the baseline

  5. Chatbot Usability

    17 questions assessing usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot.

    Measured: Two weeks after the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start18 Jan 2024
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227689
Sponsor's protocol ID
FudanU-HPV Chatbot
Status last verified
Jun 2024
First submitted
18 Jan 2024
Last updated
12 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 33243631

  • 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.

    PubMed 34741816

  • 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.

    PubMed 31255301

  • 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.

    PubMed 32707126

  • 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.

    PubMed 36284538

  • 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.

    PubMed 26936076

  • 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.

    PubMed 34324411

  • 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.

    PubMed 36229401

  • 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.

    PubMed 33121330

  • 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.

    PubMed 32245644

  • 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.

    PubMed 35229931

  • 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.

    PubMed 35088609

  • 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.

    PubMed 36178723

  • 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.

    PubMed 36179132

  • 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.

    PubMed 37231110

Questions about this trial

What is this clinical trial studying?

A study testing Vaccine chatbot that offering HPV vaccine-related information in people with HPV Vaccine, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhiyuan Hou, PhD (86+21 33563935, zyhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV vaccination status and appointment (time frame: Two weeks and four months after the baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06227689, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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