Clinical trial NCT06405048: Impact of a Mock-up Fact-checking Extension on HPV Vaccine Misinformation: A Survey Experiment
Official title: Evaluating the Feasibility and Effectiveness of a Mock-up Fact-checking Extension to Improve Ability to Debunk HPV Vaccine Misinformation Among Parents of Middle School Girls: A Survey Experiment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HPV Vaccine
Keywords: HPV vaccine
knowledge
misinformation
vaccine confidence
fact-checking extension
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2024-05-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ability to debunk misinformation
timeFrame: Day 1, in a single survey
Secondary outcomes:
measure: HPV vaccination intention
timeFrame: Day 1, in a single survey
measure: HPV vaccine confidence
timeFrame: Day 1, in a single survey
measure: Tool acceptance
timeFrame: Day 1, in a single survey
measure: User experience of mock-up fact-checking extension
timeFrame: Day 1, in a single survey
Other outcomes:
Locations:
city: Chizhou
country: China
facility: Chizhou Health Center for Disease Control and Prevention
state: Anhui
city: Shanghai
country: China
facility: Jiading District Center for Disease Control and Prevention
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhiyuan Hou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong
name: Leesa Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.