NCT06341738

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 15, 2024

Last Update Submit

March 25, 2024

Conditions

Keywords

vaccinehuman papillomavirusdigital educationparenttrial

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

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

Behavioral: Video education about HPV and HPV vaccineBehavioral: Electronic reminder messages

Usual Information Service Group

ACTIVE COMPARATOR

the control group will only receive the usual information service from staff

Behavioral: Usual Information Service

Interventions

video animation in 8 minutes to promote about HPV and HPV vaccine. the video is played in front of class using LCD projector.

DIgital Education Group

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.

DIgital Education Group

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

Usual Information Service Group

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elementary school

Ngawi, East Java, 63271, Indonesia

Location

Related Publications (17)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Yudisa Diaz Lutfi Sandi, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN., MSN., PhD Candidate (Principal Investigator)

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 2, 2024

Study Start

July 5, 2023

Primary Completion

February 1, 2024

Study Completion

February 29, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

due to confidentiality protocols, participant data cannot be shared.

Locations