The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates

Health Services Research Clinical Trial

Official title:

The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's HPV Vaccination Rates in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06341738
• Other study ID #: 421/215/404.102.28/VI/2023
• Status: Completed
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Kaohsiung Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to examine in the parental HPV knowledge and attitude, and their children's completion rates in Indonesia. The main question[s] it aims to answer are:

• 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

Description:

Research process started after obtaining permission principal of the elementary school and primary health centre. Because the target population was parents of girls in the 5-6th level, permission was required from the elementary schools. Meanwhile, another permission must be obtained from the Primary Health Centre, they have authority to administer the HPV vaccine to children at the school.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: February 29, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Parents over 17 years old

• 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 have diagnosed with mental, visual, and hearing impairment/problems diagnosed by doctors

• 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

Related Conditions & MeSH terms

• Health Services Research

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Indonesia	Elementary school	Ngawi	East Java

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

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: 1 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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/s409 — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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 Cont — View Citation

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. — View Citation

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/s — View Citation

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 No — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Papillomavirus Knowledge Scale (HPV-KS)	consist of 33 items divided into 3 factors with binary respond format (true/false). the correct answer indicated "1" point. The sum of items is HPV knowledge level. High score indicated high knowledge about HPV	measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).
Primary	Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS)	consist of 14 items divided into 3 factors with 4-Likert scale. A high mean score total attitude indicated a high positive attitudes	measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).
Primary	Vaccine completion rate	Receipt of two doses is considered vaccine series completion according vaccine policy in Indonesia	The evaluation was conducted twice, at week 2 post video intervention or at first vaccination event and 6 months later at second vaccination event.