AzTrials
AzTrials

Health Services ResearchNCT06341738

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

A study testing Video education about HPV and HPV vaccine, Electronic reminder messages and Usual Information Service in people with Health Services Research, run by Kaohsiung Medical University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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?… Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Health Services Research
What is being tested?
Video education about HPV and HPV vaccine, Electronic reminder messages and Usual Information Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
1 siteIndonesia
Study dates
5 Jul 2023to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Elementary school

    Ngawi, East Java, 63271

Other trials in Indonesia

About this study

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

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?
Read more

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
Read the detailed 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.
Being tested
Video education about HPV and HPV vaccine, Electronic reminder messages, Usual Information Service
Keywords
vaccine, human papillomavirus, digital education, parent, trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video education about HPV and HPV vaccineBehavioural

    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 messagesBehavioural

    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 ServiceBehavioural

    this usual information (e.g., the HPV vaccination event) was delivered face-to-face by staff in front of class

Study groups in NCT06341738
Study groupRoleWhat they receive
DIgital Education GroupExperimentalThe 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
Receives: Behavioral: Video education about HPV and HPV vaccine; Behavioral: Electronic reminder messages
Usual Information Service GroupActive comparatorthe control group will only receive the usual information service from staff
Receives: Behavioral: Usual Information Service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).

  2. 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: measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).

  3. Vaccine completion rate

    Receipt of two doses is considered vaccine series completion according vaccine policy in Indonesia

    Measured: The evaluation was conducted twice, at week 2 post video intervention or at first vaccination event and 6 months later at second vaccination event.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start5 Jul 2023
  3. Primary completion1 Feb 2024
  4. Study completion29 Feb 2024

Resources

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
Model description
10 units are divided into 2 arms (e.g. intervention and control) by cluster randomisation using the number of units into a sealed envelope. the participants are unaware of which group they were placed in
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341738
Sponsor's protocol ID
421/215/404.102.28/VI/2023
Status last verified
Mar 2024
First submitted
15 Mar 2024
Last updated
2 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: due to confidentiality protocols, participant data cannot be shared.

Publications

  • 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.

    PubMed 32692948
  • 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.

    PubMed 25438965
  • 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.

    PubMed 27340003
  • 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.

    PubMed 34958306
  • 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.

    PubMed 31350949
  • 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.

    PubMed 12415064
  • 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.

    PubMed 29483541
  • 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.

    PubMed 30773231
  • 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.

    PubMed 28877862
  • 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.

    PubMed 30779682
  • 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.

    PubMed 31368438
  • 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.

    PubMed 28493904
  • 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.

    PubMed 21226933
  • 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.

    PubMed 32435520
  • 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.

    PubMed 29161946

Questions about this trial

What is this clinical trial studying?

A study testing Video education about HPV and HPV vaccine, Electronic reminder messages and Usual Information Service in people with Health Services Research, run by Kaohsiung Medical University at 1 site in Indonesia.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Human Papillomavirus Knowledge Scale (HPV-KS) (time frame: measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).). The study lists 3 primary outcomes in all. 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 NCT06341738, which also lists 17 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 2 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in