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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:
Participants in intervention group will:
Participants in control group will:
• Receive usual announcement regarding vaccine by staff
Full 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:
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
374 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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