HPV VaccineNCT07200570
Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy
A study testing LLM-Powered HPV Vaccine Chatbot in people with HPV Vaccine, run by Fudan University.
Trial summary
The goal of this clinical trial is to learn if a chatbot powered by artificial intelligence works to improve HPV vaccination among females aged 15 to 45 in China. A randomized controlled trial and implementation science study will be conducted targeting females as participants. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccine
- What is being tested?
- LLM-Powered HPV Vaccine Chatbot
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female, aged 15 to 45 years, inclusive.
- Not previously vaccinated against HPV.
- Reports no contraindications to HPV vaccination.
- Has no mental, visual, or reading impairments that would preclude cooperation with study activities.
- Is willing and able to provide informed consent.
Who cannot join
- Male.
- Age under 15 or over 45 years.
- Has a history of prior HPV vaccination.
- Has a known contraindication to HPV vaccination.
- Unable to comply with study procedures.
- Is unwilling or unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy: a Randomized Controlled Trial and Implementation Science Study
The goal of this clinical trial is to learn if a chatbot powered by artificial intelligence works to improve HPV vaccination among females aged 15 to 45 in China. A randomized controlled trial and implementation science study will be conducted targeting females as participants. The main questions it aims to answer are:
- Does the vaccine chatbot influence women's confidence, literacy, hesitancy, and uptake of the HPV vaccine.
- What are the public acceptance of chatbot and the facilitators and barriers to its implementation in a real-world setting.
Read more
Researchers will compare a group of women who use the chatbot with a group who do not use it to see if the chatbot is effective at helping women feel confident and willing to get vaccinated against HPV.
Participants will:
- Be recruited and randomly allocated into one of two groups. One group will be invited to use the HPV vaccine chatbot and the other group will not get access to the vaccine chatbot until the end of the trial.
- Complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine.
- Have their vaccination status checked at the end of trial.
Read the detailed description
A randomized controlled trial with 2 arms will be conducted to evaluate the effectiveness of an LLM-powered chatbot on improving HPV vaccination among females aged 15 to 45, followed by a pragmatic implementation science study to assess the public acceptance of chatbot and to identify the facilitators and barriers to its implementation in a real-world setting.
The sample size is calculated based on the primary outcome of the HPV vaccination uptake among females aged 15 to 45 in China. This uptake is around 10% according to the China CDC estimation, and we assume that it can increase to 15% following the intervention. With a significance level (α) of 0.05 and 80% power (1-β=0.8), a sample size of at least 683 per group is needed to detect a 5% absolute difference in vaccination rate (from an assumed baseline rate of 10% to 15% post-intervention). The sample size is inflated to 900 per group to account for potential loss to follow-up and to ensure adequate power for a multi-center design.
Participant recruitment will be conducted using a multistage sampling approach across eastern, central, and western China. In each of three provinces, one urban area and one or two rural area will be selected. Participants meeting the inclusion criteria will be invited to participate and provide informed consent. For those aged 15 to 17, both parental or legal guardian consent and adolescent assent will be obtained. A randomization method will be employed to ensure balanced allocation across two groups, and the randomization sequence will be generated by an independent statistician to ensure a 1:1 allocation ratio. Participants and on-site intervention staff cannot be blinded; personnel responsible for blinded outcome assessment and statistical analysis will remain unaware of allocation.
Participants in the intervention group will be invited to use the HPV vaccine chatbot as well as a routine HPV educational pamphlet . The chatbot powered by a large language model (LLM), offers a scalable, accessible, and interactive platform around the HPV vaccine information. At the recruitment site, participants will access the chatbot through WeChat or a web browser and will be asked to use it for around five minutes. A WeChat group will be established, and the chatbot access link will be sent at one week, half a month, one month, one and half month, two months following the enrollment. The control group will not get access to the vaccine chatbot until the end of the trial and will receive standard care by a routine educational pamphlet about HPV infection and vaccination. Following the intervention, all participants will complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine. And their vaccination status will be obtained from official vaccination records at the end of trial.
The intention-to-treat (ITT) analysis will be used to evaluate the effectiveness of the intervention. Between-group comparisons will use t-tests for continuous variables and chi-square tests for categorical variables. HPV vaccine uptake as the primary outcome will be analyzed using log-binomial regression with study center included as a fixed effect and prespecified covariates included for adjustment. Risk ratios and adjusted absolute risk differences with 95% confidence intervals will be reported. If the log-binomial model does not converge, modified Poisson regression with robust sandwich variance estimation will be used. Timing of vaccination will be evaluated using Kaplan-Meier survival curves and log-rank tests, with Cox proportional hazards models to estimate intervention effects on time-to-vaccination. Binary secondary outcomes such as vaccine hesitancy and perceived disease risk will be analyzed using log-binomial or modified Poisson regression, consistent with the primary-outcome analysis; and continuous secondary outcomes such as vaccine confidence and literacy will be analyzed using linear regression models that account for study-center effects and adjust for prespecified baseline covariates. Prespecified subgroup analyses will assess heterogeneity of intervention effects across populations stratified by baseline characteristics. In addition, a per-protocol analysis will be conducted on the primary outcome, and within the intervention group, the effect of intervention intensity measured by chatbot engagement levels on primary outcome will also be evaluated.
- Conditions
- HPV Vaccine
- Being tested
- LLM-Powered HPV Vaccine Chatbot
- Keywords
- HPV, vaccine confidence, chatbot, randomised controlled trial, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-Powered HPV Vaccine ChatbotBehavioural
A vaccine chatbot delivered via WeChat or a web browser, designed to provide information and health education about the HPV vaccine. The chatbot is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the WHO and China CDC to ensure accuracy. The knowledge base is validated by experts. The chatbot engages users in interactive, conversational dialogue to answer questions and address concerns regarding HPV and HPV vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Intervention Group | Experimental | In addition to the routine HPV educational pamphlet, participants in this arm will be granted access to an interactive, LLM-powered HPV vaccine chatbot for a period of three months. They are invited to use the chatbot to ask any questions related to HPV and HPV vaccine to receive personalized and accurate information. At the recruitment site, participants will be asked to use the chatbot for around five minutes. Participants aged 15 to 17 years will use it together with a parent or legal guardian. The chatbot invitation will be sent five times through a WeChat group to reinforce the intervention - one week, half a month, one month, one and half month, two months following the enrollment. Receives: Behavioral: LLM-Powered HPV Vaccine Chatbot |
| Control Group | No intervention | Participants assigned to the control arm will receive standard care by a routine educational pamphlet about HPV infection and vaccination, but will not have access to the HPV vaccine chatbot during the study period. For ethical considerations, participants in this arm will be offered access to the chatbot after the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccine Uptake
Whether participants get vaccinated against HPV, measured by official vaccination records.
Measured: Three months after participant randomization allocation
Secondary outcomes (7)
HPV Vaccine Hesitancy
HPV vaccine hesitancy will be measured to assess a participant's plan to receive the HPV vaccine within one year, with five response options ranging from "definitely yes" to "definitely no". It will be categorized as hesitant or not.
Measured: The same day after the intervention
HPV Vaccine Confidence
Vaccine Confidence Index (VCI) that assesses confidence in the importance, effectiveness, and safety of vaccines using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). A higher score indicates greater confidence.
Measured: The same day after the intervention
HPV Vaccine Literacy
A series of questions about HPV vaccine knowledge and misinformation. Total literacy score is calculated based on the number of 11 questions answered correctly by the participants.
Measured: The same day after the intervention
Timing of HPV Vaccination
Number of days from randomization to receipt of the first HPV vaccine dose, measured by official vaccination records
Measured: Within three months after participant randomization allocation
Perceived Risk of HPV-Related Disease
Perceived susceptibility to and perceived severity of HPV-related disease, assessed by questionnaire and categorized as high or low risk perception.
Measured: The same day after the intervention
Chatbot Usability
A series of 9 questions using 5-point Likert response options to assess the usability and feasibility, fairness and safety, user experience, and overall assessment of the chatbot.
Measured: The same day after the intervention
Cost of interventions
The cost of designing and implementing chatbot interventions. Unit of Measure: Chinese Yuan (CNY).
Measured: Within three months after participant randomization allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startAug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HPV VaccineStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Zhiyuan Hou, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200570
- Sponsor's protocol ID
- Fudan-HPV LLM chatbot
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy concerns and institutional data protection policies.
Publications
Weeks R, Sangha P, Cooper L, Sedoc J, White S, Gretz S, Toledo A, Lahav D, Hartner AM, Martin NM, Lee JH, Slonim N, Bar-Zeev N. Usability and Credibility of a COVID-19 Vaccine Chatbot for Young Adults and Health Workers in the United States: Formative Mixed Methods Study. JMIR Hum Factors. 2023 Jan 30;10:e40533. doi: 10.2196/40533.
PubMed 36409300Weeks 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.
PubMed 35737898Kobayashi 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.
PubMed 35750541Almalki 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.
PubMed 33627924Wilson 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.
PubMed 36197708Luk 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 36179132Si 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 36178723Si 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 35088609Wang 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 35229931Zhang 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 32245644Zhang 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 33121330Wei 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 36229401Xie 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 34324411Zhang 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 26936076Zang 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy: a Randomized Controlled Trial and Implementation Science Study
- ClinicalTrials.gov ID
- NCT07200570
- Acronym / sponsor ID
- Fudan-HPV LLM chatbot
- Conditions
- HPV Vaccine
- Keywords
- HPV, vaccine confidence, chatbot, randomised controlled trial, implementation science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a chatbot powered by artificial intelligence works to improve HPV vaccination among females aged 15 to 45 in China. A randomized controlled trial and implementation science study will be conducted targeting females as participants. The main questions it aims to answer are:
- Does the vaccine chatbot influence women's confidence, literacy, hesitancy, and uptake of the HPV vaccine.
- What are the public acceptance of chatbot and the facilitators and barriers to its implementation in a real-world setting.
Researchers will compare a group of women who use the chatbot with a group who do not use it to see if the chatbot is effective at helping women feel confident and willing to get vaccinated against HPV.
Participants will:
- Be recruited and randomly allocated into one of two groups. One group will be invited to use the HPV vaccine chatbot and the other group will not get access to the vaccine chatbot until the end of the trial.
- Complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine.
- Have their vaccination status checked at the end of trial.
Detailed description
A randomized controlled trial with 2 arms will be conducted to evaluate the effectiveness of an LLM-powered chatbot on improving HPV vaccination among females aged 15 to 45, followed by a pragmatic implementation science study to assess the public acceptance of chatbot and to identify the facilitators and barriers to its implementation in a real-world setting.
The sample size is calculated based on the primary outcome of the HPV vaccination uptake among females aged 15 to 45 in China. This uptake is around 10% according to the China CDC estimation, and we assume that it can increase to 15% following the intervention. With a significance level (α) of 0.05 and 80% power (1-β=0.8), a sample size of at least 683 per group is needed to detect a 5% absolute difference in vaccination rate (from an assumed baseline rate of 10% to 15% post-intervention). The sample size is inflated to 900 per group to account for potential loss to follow-up and to ensure adequate power for a multi-center design.
Participant recruitment will be conducted using a multistage sampling approach across eastern, central, and western China. In each of three provinces, one urban area and one or two rural area will be selected. Participants meeting the inclusion criteria will be invited to participate and provide informed consent. For those aged 15 to 17, both parental or legal guardian consent and adolescent assent will be obtained. A randomization method will be employed to ensure balanced allocation across two groups, and the randomization sequence will be generated by an independent statistician to ensure a 1:1 allocation ratio. Participants and on-site intervention staff cannot be blinded; personnel responsible for blinded outcome assessment and statistical analysis will remain unaware of allocation.
Participants in the intervention group will be invited to use the HPV vaccine chatbot as well as a routine HPV educational pamphlet . The chatbot powered by a large language model (LLM), offers a scalable, accessible, and interactive platform around the HPV vaccine information. At the recruitment site, participants will access the chatbot through WeChat or a web browser and will be asked to use it for around five minutes. A WeChat group will be established, and the chatbot access link will be sent at one week, half a month, one month, one and half month, two months following the enrollment. The control group will not get access to the vaccine chatbot until the end of the trial and will receive standard care by a routine educational pamphlet about HPV infection and vaccination. Following the intervention, all participants will complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine. And their vaccination status will be obtained from official vaccination records at the end of trial.
The intention-to-treat (ITT) analysis will be used to evaluate the effectiveness of the intervention. Between-group comparisons will use t-tests for continuous variables and chi-square tests for categorical variables. HPV vaccine uptake as the primary outcome will be analyzed using log-binomial regression with study center included as a fixed effect and prespecified covariates included for adjustment. Risk ratios and adjusted absolute risk differences with 95% confidence intervals will be reported. If the log-binomial model does not converge, modified Poisson regression with robust sandwich variance estimation will be used. Timing of vaccination will be evaluated using Kaplan-Meier survival curves and log-rank tests, with Cox proportional hazards models to estimate intervention effects on time-to-vaccination. Binary secondary outcomes such as vaccine hesitancy and perceived disease risk will be analyzed using log-binomial or modified Poisson regression, consistent with the primary-outcome analysis; and continuous secondary outcomes such as vaccine confidence and literacy will be analyzed using linear regression models that account for study-center effects and adjust for prespecified baseline covariates. Prespecified subgroup analyses will assess heterogeneity of intervention effects across populations stratified by baseline characteristics. In addition, a per-protocol analysis will be conducted on the primary outcome, and within the intervention group, the effect of intervention intensity measured by chatbot engagement levels on primary outcome will also be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot Intervention Group | Experimental | Behavioral: LLM-Powered HPV Vaccine ChatbotIn addition to the routine HPV educational pamphlet, participants in this arm will be granted access to an interactive, LLM-powered HPV vaccine chatbot for a period of three months. They are invited to use the chatbot to ask any questions related to HPV and HPV vaccine to receive personalized and accurate information. At the recruitment site, participants will be asked to use the chatbot for around five minutes. Participants aged 15 to 17 years will use it together with a parent or legal guardian. The chatbot invitation will be sent five times through a WeChat group to reinforce the intervention - one week, half a month, one month, one and half month, two months following the enrollment. |
| Control Group | No intervention | –Participants assigned to the control arm will receive standard care by a routine educational pamphlet about HPV infection and vaccination, but will not have access to the HPV vaccine chatbot during the study period. For ethical considerations, participants in this arm will be offered access to the chatbot after the end of the study. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female, aged 15 to 45 years, inclusive.
- Not previously vaccinated against HPV.
- Reports no contraindications to HPV vaccination.
- Has no mental, visual, or reading impairments that would preclude cooperation with study activities.
- Is willing and able to provide informed consent.
Key exclusion criteria (6 listed)
- Male.
- Age under 15 or over 45 years.
- Has a history of prior HPV vaccination.
- Has a known contraindication to HPV vaccination.
- Unable to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM-Powered HPV Vaccine ChatbotA vaccine chatbot delivered via WeChat or a web browser, designed to provide information and health education about the HPV vaccine. The chatbot is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the WHO and China CDC to ensure accuracy. The knowledge base is validated by experts. The chatbot engages users in interactive, conversational dialogue to answer questions and address concerns regarding HPV and HPV vaccines. | Behavioural | Chatbot Intervention Group |
Primary outcome
HPV Vaccine Uptake
Time frame: Three months after participant randomization allocation
Whether participants get vaccinated against HPV, measured by official vaccination records.
7 secondary outcomes
HPV Vaccine Hesitancy
Time frame: The same day after the intervention
HPV Vaccine Confidence
Time frame: The same day after the intervention
HPV Vaccine Literacy
Time frame: The same day after the intervention
Timing of HPV Vaccination
Time frame: Within three months after participant randomization allocation
Perceived Risk of HPV-Related Disease
Time frame: The same day after the intervention
Chatbot Usability
Time frame: The same day after the intervention
Cost of interventions
Time frame: Within three months after participant randomization allocation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 36409300Weeks R, Sangha P, Cooper L, Sedoc J, White S, Gretz S, Toledo A, Lahav D, Hartner AM, Martin NM, Lee JH, Slonim N, Bar-Zeev N. Usability and Credibility of a COVID-19 Vaccine Chatbot for Young Adults and Health Workers in the United States: Formative Mixed Methods Study. JMIR Hum Factors. 2023 Jan 30;10:e40533. doi: 10.2196/40533.
- Background: PubMed 35737898Weeks 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.
- Background: PubMed 35750541Kobayashi 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.
- Background: PubMed 33627924Almalki 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.
- Background: PubMed 36197708Wilson 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.
- Background: PubMed 36179132Luk 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.
- Background: PubMed 36178723Si 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.
- Background: PubMed 35088609Si 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.
- Background: PubMed 35229931Wang 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.
- Background: PubMed 32245644Zhang 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.
- Background: PubMed 33121330Zhang 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.
- Background: PubMed 36229401Wei 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy concerns and institutional data protection policies.
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Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing LLM-Powered HPV Vaccine Chatbot in people with HPV Vaccine, run by Fudan University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyuan Hou, PhD (86+21 54231112, 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 Vaccine Uptake (time frame: Three months after participant randomization allocation). 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 NCT07200570, which also lists 20 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 4 Aug 2026.