The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates
NCT ID: NCT06341738
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
374 participants
INTERVENTIONAL
2023-07-05
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Is the digital educational intervention in improving parent's HPV knowledge in the intervention group compared to the control group?
* Is the digital educational intervention in improving parent's attitude toward HPV vaccine in the intervention group compared to the control group?
* Is the digital educational intervention more effective in increasing children's HPV vaccine completion rates in the intervention group compared to the control group?
Participants in intervention group will:
* watch a 8 minutes video in front of class at once.
* after video education intervention, in 2 weeks, participants received 2 reminder messages before first and second vaccination event, respectively.
Participants in control group will:
• Receive usual announcement regarding vaccine by staff
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination
NCT03209713
Educational Intervention to Improve HPV Vaccination Decision Quality
NCT02797054
Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18
NCT06347627
Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics
NCT03111251
Assessing Knowledge, Beliefs and Attitudes Toward HPV Vaccination Among Parents in North West, Cameroon
NCT05325138
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All participants (parents) were recruited from 10 elementary schools. The schools were divided into 2 arm (e.g., Digital education group, Usual information service group) by cluster randomizing. The group allocation were concealed from the participants, elementary teachers and primary health centre. Participants were unaware of the existence of any other group than the one they received. According to sample size calculations, the number of adequate sample sizes in this study based on sample size calculation results at the completion rate. The dropout rate estimation of 10% according to a previous study by Reiter (2022), the total sample size increased to 269 + (10% x 269) = 296 participants.
The researchers got an approval from schools to invite parents to attend the school of event invitations. Each participant came to the school where their child attended. Parents attended the regular meeting on the appointed day. Frequently, event invitations have become a routine program in elementary school. It was a routine agenda to socialize interesting programs related to students and parents. In parallel with the above, the research team coordinated with the Primary Health Center as the administrator of the HPV vaccine in elementary schools. Thus, the research team determined the time to give the digital education intervention and the follow-up evaluation.
During the process, the researchers approached potential participants and explain to them the purpose of this study, participant rights, risks, and benefits. Then potential participants were asked to sign in the informed consent form with serial numbel. The outcome measurement questionnaires were distributed to the participants, either the intervention group or the control group.
At baseline, the eligible participants were asked to fill out the questionnaires. After complete, a 8 minutes video was played in front of class. Then, the participants took a post-test right after the intervention finish their meeting and in the control group as well. The post-test assessed HPV knowledge and attitudes toward the HPV vaccine. Prior vaccination events, the reminder messages were sent to parent's mobile phone. At this stage, the researcher observed the first dose of HPV vaccine uptake among female students during the HPV vaccine administration program at school. The researcher collected data by observing female students who received the first and second doses of HPV vaccine at the vaccination event, then confirmed the researcher's observations with the Primary Health Center record. All data was recapitulated and stored in excel format. Data was kept by the researcher to maintain confidentiality. All data analyses were performed using SPSS software from IBM Corp.
Statistical analyses, below:
1. Pearson Chi-Square test or Fisher's exact test was used to analyse the HPV vaccine completion rate between groups.
2. The T-test was used to analyse the HPV knowledge and attitude towards HPV vaccine between groups;
3. ANCOVA analysed the intervention efficacy on knowledge, attitude, and HPV vaccine completion rate between two groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DIgital Education Group
The intervention group will receive information on HPV and the HPV vaccine from an 8-minute video in front of the class, two electronic reminder messages send to participant before the vaccination events
Video education about HPV and HPV vaccine
video animation in 8 minutes to promote about HPV and HPV vaccine. the video is played in front of class using LCD projector.
Electronic reminder messages
Reseachers send reminder messages twice per vaccination event (e.g., 7 days and 1 day before vaccination event), with a total of four times sending reminder messages using the app on the smartphone.
Usual Information Service Group
the control group will only receive the usual information service from staff
Usual Information Service
this usual information (e.g., the HPV vaccination event) was delivered face-to-face by staff in front of class
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Video education about HPV and HPV vaccine
video animation in 8 minutes to promote about HPV and HPV vaccine. the video is played in front of class using LCD projector.
Electronic reminder messages
Reseachers send reminder messages twice per vaccination event (e.g., 7 days and 1 day before vaccination event), with a total of four times sending reminder messages using the app on the smartphone.
Usual Information Service
this usual information (e.g., the HPV vaccination event) was delivered face-to-face by staff in front of class
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parents Parents who have daughters of 5-6th level in elementary school
* Parents live with their children in one house
* Parents have a mobile phone with WhatsApp application capabilities
* Parents who have their daughters have been enrolled in School-Based Immunization Program database
* Parents able to communicate fluently in Bahasa Indonesia
* Parents agree to review their child's medical record of vaccination
Exclusion Criteria
* Parents whose children have been HPV vaccinated
* Parents whose children are over 14 years old
* Children who have a history of allergies and/or side effects in previous vaccination programs
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kaohsiung Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yudisa Diaz Lutfi Sandi
RN., MSN., PhD Candidate (Principal Investigator)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yudisa Diaz Lutfi Sandi, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elementary school
Ngawi, East Java, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen H, Zhang X, Wang W, Zhang R, Du M, Shan L, Li Y, Wang X, Liu Y, Zhang W, Li X, Qiao Y, Ma J, Zhou J, Li J. Effect of an educational intervention on human papillomavirus (HPV) knowledge and attitudes towards HPV vaccines among healthcare workers (HCWs) in Western China. Hum Vaccin Immunother. 2021 Feb 1;17(2):443-450. doi: 10.1080/21645515.2020.1780093. Epub 2020 Jul 21.
Chao C, Preciado M, Slezak J, Xu L. A randomized intervention of reminder letter for human papillomavirus vaccine series completion. J Adolesc Health. 2015 Jan;56(1):85-90. doi: 10.1016/j.jadohealth.2014.08.014. Epub 2014 Nov 1.
Bruni L, Diaz M, Barrionuevo-Rosas L, Herrero R, Bray F, Bosch FX, de Sanjose S, Castellsague X. Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis. Lancet Glob Health. 2016 Jul;4(7):e453-63. doi: 10.1016/S2214-109X(16)30099-7.
Wynn CS, Catallozzi M, Kolff CA, Holleran S, Meyer D, Ramakrishnan R, Stockwell MS. Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial. JMIR Mhealth Uhealth. 2021 Dec 27;9(12):e26356. doi: 10.2196/26356.
Taebi M, Riazi H, Keshavarz Z, Afrakhteh M. Knowledge and Attitude Toward Human Papillomavirus and HPV Vaccination in Iranian Population: A Systematic Review. Asian Pac J Cancer Prev. 2019 Jul 1;20(7):1945-1949. doi: 10.31557/APJCP.2019.20.7.1945.
Szilagyi PG, Schaffer S, Shone L, Barth R, Humiston SG, Sandler M, Rodewald LE. Reducing geographic, racial, and ethnic disparities in childhood immunization rates by using reminder/recall interventions in urban primary care practices. Pediatrics. 2002 Nov;110(5):e58. doi: 10.1542/peds.110.5.e58.
Santhanes D, Yong CP, Yap YY, Saw PS, Chaiyakunapruk N, Khan TM. Factors influencing intention to obtain the HPV vaccine in South East Asian and Western Pacific regions: A systematic review and meta-analysis. Sci Rep. 2018 Feb 26;8(1):3640. doi: 10.1038/s41598-018-21912-x.
Rodriguez AM, Do TQN, Goodman M, Schmeler KM, Kaul S, Kuo YF. Human Papillomavirus Vaccine Interventions in the U.S.: A Systematic Review and Meta-analysis. Am J Prev Med. 2019 Apr;56(4):591-602. doi: 10.1016/j.amepre.2018.10.033. Epub 2019 Feb 15.
Pot M, Paulussen TG, Ruiter RA, Eekhout I, de Melker HE, Spoelstra ME, van Keulen HM. Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial. J Med Internet Res. 2017 Sep 6;19(9):e312. doi: 10.2196/jmir.7449.
Ortiz RR, Smith A, Coyne-Beasley T. A systematic literature review to examine the potential for social media to impact HPV vaccine uptake and awareness, knowledge, and attitudes about HPV and HPV vaccination. Hum Vaccin Immunother. 2019;15(7-8):1465-1475. doi: 10.1080/21645515.2019.1581543. Epub 2019 Apr 11.
McCann L, McMillan KA, Pugh G. Digital Interventions to Support Adolescents and Young Adults With Cancer: Systematic Review. JMIR Cancer. 2019 Jul 31;5(2):e12071. doi: 10.2196/12071.
Magaard JL, Seeralan T, Schulz H, Brutt AL. Factors associated with help-seeking behaviour among individuals with major depression: A systematic review. PLoS One. 2017 May 11;12(5):e0176730. doi: 10.1371/journal.pone.0176730. eCollection 2017.
Lu B, Kumar A, Castellsague X, Giuliano AR. Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review & meta-analysis. BMC Infect Dis. 2011 Jan 12;11:13. doi: 10.1186/1471-2334-11-13.
Lopez N, Garces-Sanchez M, Panizo MB, de la Cueva IS, Artes MT, Ramos B, Cotarelo M. HPV knowledge and vaccine acceptance among European adolescents and their parents: a systematic literature review. Public Health Rev. 2020 May 14;41:10. doi: 10.1186/s40985-020-00126-5. eCollection 2020.
Loke AY, Kwan ML, Wong YT, Wong AKY. The Uptake of Human Papillomavirus Vaccination and Its Associated Factors Among Adolescents: A Systematic Review. J Prim Care Community Health. 2017 Oct;8(4):349-362. doi: 10.1177/2150131917742299. Epub 2017 Nov 21.
Dorji T, Nopsopon T, Tamang ST, Pongpirul K. Human papillomavirus vaccination uptake in low-and middle-income countries: a meta-analysis. EClinicalMedicine. 2021 Apr 17;34:100836. doi: 10.1016/j.eclinm.2021.100836. eCollection 2021 Apr.
Tudor Car L, Soong A, Kyaw BM, Chua KL, Low-Beer N, Majeed A. Health professions digital education on clinical practice guidelines: a systematic review by Digital Health Education collaboration. BMC Med. 2019 Jul 18;17(1):139. doi: 10.1186/s12916-019-1370-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
421/215/404.102.28/VI/2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.