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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIgital Education Group | Experimental | 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 |
|
| Usual Information Service Group | Active Comparator | the control group will only receive the usual information service from staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video education about HPV and HPV vaccine | Behavioral | video animation in 8 minutes to promote about HPV and HPV vaccine. the video is played in front of class using LCD projector. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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). |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yudisa Diaz Lutfi Sandi, PhD | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elementary school | Ngawi | East Java | 63271 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32692948 | Result | 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. | |
| 25438965 |
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due to confidentiality protocols, participant data cannot be shared.
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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
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| Electronic reminder messages | Behavioral | 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 | Behavioral | this usual information (e.g., the HPV vaccination event) was delivered face-to-face by staff in front of class |
|
| Result |
| 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. |
| 27340003 | Result | 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. |
| 34958306 | Result | 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. |
| 31350949 | Result | 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. |
| 12415064 | Result | 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. |
| 29483541 | Result | 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. |
| 30773231 | Result | 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. |
| 28877862 | Result | 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. |
| 30779682 | Result | 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. |
| 31368438 | Result | 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. |
| 28493904 | Result | 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. |
| 21226933 | Result | 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. |
| 32435520 | Result | 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. |
| 29161946 | Result | 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. |
| 33997733 | Result | 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. |
| 31315642 | Result | 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. |
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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