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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06405048
Other study ID # Fact-checking Extension
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 28, 2024
Est. completion date June 30, 2024

Study information

Verified date May 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

The primary objective of this survey experiment study is to measure the impact of a mock-up Chinese fact-checking extension on the ability to dispel HPV and HPV vaccine-related misinformation among parents of middle school girls in China.


Description:

This survey experiment study aims to assess the feasibility and effectiveness of a mock-up Chinese fact-checking extension on improving the ability to identify HPV and HPV vaccine-related misinformation among parents of middle school girls in three economically diverse regions of China. This includes Shanghai megacity, an urban city in Anhui Province, and rural counties in Anhui Province. The participants will be parents of middle school girls who have not yet received the HPV vaccine. This experiment will randomly assign the participants into intervention or control group. Participants in the intervention group will use a mock-up Chinese fact-checking extension whereas those in control group will not. The sample size for this study was determined based on the two primary outcomes: knowledge of the HPV vaccine and the ability to dispel misinformation. A review of the existing literature suggests that the intention or confidence among Chinese parents to vaccinate their children with the HPV vaccine, as well as their knowledge about the vaccine and capability to counteract misinformation, typically ranges from 50% to 70%. We assumed a baseline rate of 60% for both vaccine knowledge and misinformation discernment. It is anticipated that exposure to educational interventions will increase these rates by 10%, elevating them to 70%. Using a significance level of 0.05 and a statistical power of 90%, the required sample size was calculated to be a minimum of 473 participants per group. To accommodate potential variability and to strengthen the robustness of the study, 500 participants will be recruited for each group, maintaining a 1:1 ratio. This approach results in a total sample size of 1,000 participants. Such a sample size ensures that the study is sufficiently powered to detect a significant change in the outcomes of interest. In this study, 11 mobile Weibo post screenshots were created, covering a range of topics including infertility, safety, vaccine ingredients, high-risk cervical cancer types, regular check-ups, transmission routes, and others. The participants in both groups will complete a questionnaire consisting of six phases: 1. Phase 1 (Baseline Assessment): Participants in both the intervention and control groups will complete a questionnaire covering (a) basic demographic information, (b) HPV vaccine knowledge, (c) HPV vaccine awareness and confidence, and (d) vaccination intentions. 2. Phase 2 (Intervention Module 1): Participants in the intervention group will review six Weibo post screenshots, each featuring a mock-up Chinese fact-checking extension. The control group will view identical screenshots, but without the fact-checking extension. Half of these posts will include false information. After viewing each post, those in the intervention group will evaluate a statement related to the Weibo content and corresponding to one of the predefined (b) HPV vaccine knowledge. Their responses will be: 1) Correct, 2) Incorrect, or 3) I don't know, considering both the post content and the fact-checking extension's findings. Participants in the control group will assess the same statement based only on the post content, with the same response options. 3. Phase 3 (Intervention Module 2): All participants will review four additional Weibo post screenshots, including two containing false information, to evaluate whether exposure to the mock-up fact-checking extension has improved the intervention group's ability to identify false information. The same question format from Intervention Module 1 will be used for responses. 4. Phase 4 (Post-intervention Assessment): All participants are required to fill out sections on (c) HPV vaccine awareness and confidence, and (d) vaccine intentions. 5. Phase 5 (Intervention Module 3): All participants in both groups will be asked whether they use a mock-up fact-checking extension when viewing Weibo post screenshots. If participants choose 'Yes', they will view a Weibo post screenshot with the extension displayed; if they choose 'No', the extension will not be displayed. The same question format from Intervention Module 1 will be used for responses. This phase aims to assess participants' behaviour regarding the use of the extension. 6. Phase 6 (User Experience Assessment): All participants will complete the section (e) the user experience with a mock-up fact-checking extension. Following the completion of the experiment, a debunking procedure will be conducted for participants in both the intervention and control groups. This is to avoid any potential risks associated with the spread of misinformation on Weibo. Data analysis will employ Difference-in-Differences (DID) analysis, multiple logistic regression, and other suitable statistical methods to evaluate the effectiveness of the mock-up Chinese fact-checking extension.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants must be parents or legal guardians of female students currently enrolled in participating middle school. 2. The parent's or guardian's female middle school student must not have received the HPV vaccine, must not have an HPV vaccination appointment scheduled, and must not have any contraindications to receiving the HPV vaccine. 3. Participants must be free of mental health disorders or visual/reading disabilities that could prevent their full participation in and completion of the intervention activities. 4. Participants must have provided informed consent and expressed a willingness to actively participate throughout the study. Exclusion criteria are defined as individuals not meeting the aforementioned inclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile Weibo post screenshot with mock-up Chinese fact-checking extension
The intervention in this survey experiment involves mobile Weibo post screenshots equipped with a mock-up Chinese fact-checking browser extension. All screenshots are based on actual Weibo posts. The fact-checking content is generated by a Large Language Model (LLM), tailored to relevant knowledge and prompts, and subsequently validated by experts. The Weibo posts cover a range of popular topics known to contain misinformation, including infertility, safety, vaccine ingredients, high-risk cervical cancer types, regular check-ups, transmission routes, and others.

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 (17)

Bin Naeem S, Kamel Boulos MN. COVID-19 Misinformation Online and Health Literacy: A Brief Overview. Int J Environ Res Public Health. 2021 Jul 30;18(15):8091. doi: 10.3390/ijerph18158091. — View Citation

Chen L, Wang X, Peng TQ. Nature and Diffusion of Gynecologic Cancer-Related Misinformation on Social Media: Analysis of Tweets. J Med Internet Res. 2018 Oct 16;20(10):e11515. doi: 10.2196/11515. — View Citation

Hu D, Martin C, Dredze M, Broniatowski DA. Chinese social media suggest decreased vaccine acceptance in China: An observational study on Weibo following the 2018 Changchun Changsheng vaccine incident. Vaccine. 2020 Mar 17;38(13):2764-2770. doi: 10.1016/j.vaccine.2020.02.027. Epub 2020 Feb 22. — View Citation

Huang S, Yang J, Fong S, Zhao Q. Artificial intelligence in the diagnosis of COVID-19: challenges and perspectives. Int J Biol Sci. 2021 Apr 10;17(6):1581-1587. doi: 10.7150/ijbs.58855. eCollection 2021. — View Citation

Huang Y, Xu S, Xu Y, Yao D, Wang L, Zhao Y, Wu Q. A New Strategy for Cervical Cancer Prevention Among Chinese Women: How Much Do They Know and How Do They React Toward the HPV Immunization? J Cancer Educ. 2021 Apr;36(2):386-394. doi: 10.1007/s13187-019-01642-y. — View Citation

Keelan J, Pavri V, Balakrishnan R, Wilson K. An analysis of the Human Papilloma Virus vaccine debate on MySpace blogs. Vaccine. 2010 Feb 10;28(6):1535-40. doi: 10.1016/j.vaccine.2009.11.060. Epub 2009 Dec 8. — 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 Singapore. NPJ Digit Med. 2023 May 25;6(1):96. doi: 10.1038/s41746-023-00843-6. — View Citation

Li C, Wu M, Wang J, Zhang S, Zhu L, Pan J, Zhang W. A population-based study on the risks of cervical lesion and human papillomavirus infection among women in Beijing, People's Republic of China. Cancer Epidemiol Biomarkers Prev. 2010 Oct;19(10):2655-64. doi: 10.1158/1055-9965.EPI-10-0212. Epub 2010 Aug 18. — View Citation

Li K, Li Q, Song L, Wang D, Yin R. The distribution and prevalence of human papillomavirus in women in mainland China. Cancer. 2019 Apr 1;125(7):1030-1037. doi: 10.1002/cncr.32003. Epub 2019 Feb 12. — View Citation

Li X, Xiang F, Dai J, Zhang T, Chen Z, Zhang M, Wu R, Kang X. Prevalence of cervicovaginal human papillomavirus infection and genotype distribution in Shanghai, China. Virol J. 2022 Sep 12;19(1):146. doi: 10.1186/s12985-022-01879-y. — View Citation

Norman CD, Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked World. J Med Internet Res. 2006 Jun 16;8(2):e9. doi: 10.2196/jmir.8.2.e9. — View Citation

Scherer LD, McPhetres J, Pennycook G, Kempe A, Allen LA, Knoepke CE, Tate CE, Matlock DD. Who is susceptible to online health misinformation? A test of four psychosocial hypotheses. Health Psychol. 2021 Apr;40(4):274-284. doi: 10.1037/hea0000978. Epub 2021 Mar 1. — View Citation

Southwick L, Guntuku SC, Klinger EV, Seltzer E, McCalpin HJ, Merchant RM. Characterizing COVID-19 Content Posted to TikTok: Public Sentiment and Response During the First Phase of the COVID-19 Pandemic. J Adolesc Health. 2021 Aug;69(2):234-241. doi: 10.1016/j.jadohealth.2021.05.010. Epub 2021 Jun 22. — View Citation

Tangcharoensathien V, Calleja N, Nguyen T, Purnat T, D'Agostino M, Garcia-Saiso S, Landry M, Rashidian A, Hamilton C, AbdAllah A, Ghiga I, Hill A, Hougendobler D, van Andel J, Nunn M, Brooks I, Sacco PL, De Domenico M, Mai P, Gruzd A, Alaphilippe A, Briand S. Framework for Managing the COVID-19 Infodemic: Methods and Results of an Online, Crowdsourced WHO Technical Consultation. J Med Internet Res. 2020 Jun 26;22(6):e19659. doi: 10.2196/19659. — 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/s12889-016-2873-8. — View Citation

Zhao FH, Lin MJ, Chen F, Hu SY, Zhang R, Belinson JL, Sellors JW, Franceschi S, Qiao YL, Castle PE; Cervical Cancer Screening Group in China. Performance of high-risk human papillomavirus DNA testing as a primary screen for cervical cancer: a pooled analysis of individual patient data from 17 population-based studies from China. Lancet Oncol. 2010 Dec;11(12):1160-71. doi: 10.1016/S1470-2045(10)70256-4. Epub 2010 Nov 11. Erratum In: Lancet Oncol. 2011 Jan;12(1):11. — View Citation

Zimet GD, Rosberger Z, Fisher WA, Perez S, Stupiansky NW. Beliefs, behaviors and HPV vaccine: correcting the myths and the misinformation. Prev Med. 2013 Nov;57(5):414-8. doi: 10.1016/j.ypmed.2013.05.013. Epub 2013 May 31. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to debunk misinformation This outcome measures participants' ability to debunk misinformation about the HPV or HPV vaccine. Total debunking scores range from 0 to 10, with higher scores reflecting better debunking skills. Day 1, in a single survey
Secondary HPV vaccination intention Intention to vaccinate daughters against HPV, measured on a five-point Likert scale from 0 ("very unwilling") to 5 ("very willing"). Day 1, in a single survey
Secondary HPV vaccine confidence Vaccine Confidence Index (VCI), including confidence on vaccine effectiveness and safety, measured on a five-point Likert scale from 0 ("strongly disagree") to 5 ("strongly agree"). Day 1, in a single survey
Secondary Tool acceptance Determines whether participants would like to use a mock-up fact-checking extension when viewing screenshots of Weibo posts. Responses are either Yes (1) or No (0). Day 1, in a single survey
Secondary User experience of mock-up fact-checking extension 4 questions about the user experience of a mock-up fact-checking browser extension, measured using a five-point Likert scale from "strongly disagree" to "strongly agree" Day 1, in a single survey
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