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

March 25, 2024 updated by: Yudisa Diaz Lutfi Sandi, Kaohsiung Medical University

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?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Ngawi, East Java, Indonesia, 63271
        • Elementary school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Behavioral: 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.
Active Comparator: Usual Information Service Group
the control group will only receive the usual information service from staff
Behavioral: Usual Information Service
this usual information (e.g., the HPV vaccination event) was delivered face-to-face by staff in front of class

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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).
Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS)
Time Frame: measured at pre-test/baseline (before the 8-minutes video) and post-test (immediately after watching the 8-minutes video).
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).
Vaccine completion rate
Time Frame: The evaluation was conducted twice, at week 2 post video intervention or at first vaccination event and 6 months later at second vaccination event.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Investigators

  • Principal Investigator: Yudisa Diaz Lutfi Sandi, PhD, Kaohsiung Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 421/215/404.102.28/VI/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

due to confidentiality protocols, participant data cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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