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ParentsNCT06466252

Development and Psychometric Testing of HPV Knowledge Scale

An observational study of Parents and Parent-Child Relations, 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
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Trial summary

The aim of this study is to develop and conduct psychometric testing of a new scale, the Human Papillomavirus Knowledge Scale (HPV-KS), particularly designed to assess HPV knowledge among parents of school-age children in Indonesia. Read more about this study

Who is it for?
Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for
Parents, Parent-Child Relations
What is being tested?
Psychometric Group
How many people
673 participants
Where
1 siteIndonesia
Study dates
1 Feb 2023to 1 May 2023
Phase
Observational
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All participants were parents who had children in elementary school. they come from several different educational variations, ethnicities, religions, places of residence, and economic levels. This research involved five elementary schools in rural areas. The population in rural was chosen to provide an overview of the understanding of rural communities regarding the feasibility of this new instrument.

Who may be able to join

  • Participants have a child in elementary school
  • Participants could speak Bahasa Indonesia fluently
  • Participants live with their children in one house
  • Participants are willing to participate in the study

Who cannot join

  • parents had mental, visual, and hearing impairments or problems diagnosed by doctors
  • their children' age are over 14 years old.

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: Development and Psychometric Testing of a Questionnaire to Assess HPV Knowledge in Indonesia

The aim of this study is to develop and conduct psychometric testing of a new scale, the Human Papillomavirus Knowledge Scale (HPV-KS), particularly designed to assess HPV knowledge among parents of school-age children in Indonesia.

Read the detailed description

research process after obtaining school principal. because the target population was parents who have daughters in elementary schools.

All participants (parents) were recruited from 5 elementary schools. According to a minimum sample size estimation for a psychometric study, it needs 10 times the total number of items (Boateng, 2018). the total participants, 52 items x 10= 520 participants were required.

The researchers got 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. at that time, researchers approached potential participants to explain to them the purpose of this study, participant rights, risks, and benefits. The researcher obtained participants' consent to participate in this research with a serial number.

During the process, researchers keep the participant anonymous. The questionnaires were distributed to the participants and took around 15-20 minutes to complete. All data was recapitulated and stored in Excel format. Data were kept by the researcher to maintain confidentiality. All data analyses were performed using SPSS software from IBM Corp.

Statistical analyses are below:

  1. Descriptive analysis was used to identify population characteristics
  2. Validity testing contains Exploratory and Confirmatory factor analyses were structure and construct.
  3. Reliability testing was done using Cronbach alpha to determine the instrument's reliability.
Being tested
Psychometric Group
Keywords
Human papillomavirus, parent, knowledge, Instrument development, psychometric test

What participants receive

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

  • Psychometric GroupBehavioural

    There are no interventions

What is being measured

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

  1. Human papillomavirus knowledge scale

    it consists of 3 subscales assessed awareness and understanding about human papillomavirus that encompass transmission, related to diseases, prevention, vaccine domestic policy context. it has a binary response format with a true /false response. the items contain favourable and unfavourable statement. A 1-point reflects that the answer is correct and 0-point is incorrect answer. The total scores indicated the knowledge level. The higher score means a better knowledge level

    Measured: one time collected. participants took 15 minutes to complete all items in form.

Timeline

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

  1. First posted20 Jun 2024
  2. Study start1 Feb 2023
  3. Primary completion1 Apr 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466252
Sponsor's protocol ID
421/061/404.102.28/II/2023
Status last verified
Jun 2024
First submitted
11 Jun 2024
Last updated
20 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hoppe-Seyler K, Bossler F, Braun JA, Herrmann AL, Hoppe-Seyler F. The HPV E6/E7 Oncogenes: Key Factors for Viral Carcinogenesis and Therapeutic Targets. Trends Microbiol. 2018 Feb;26(2):158-168. doi: 10.1016/j.tim.2017.07.007. Epub 2017 Aug 17.

    PubMed 28823569

  • Li Y, Xu C. Human Papillomavirus-Related Cancers. Adv Exp Med Biol. 2017;1018:23-34. doi: 10.1007/978-981-10-5765-6_3.

    PubMed 29052130

  • Songane M, Grossmann V. The patent buyout price for human papilloma virus (HPV) vaccine and the ratio of R&D costs to the patent value. PLoS One. 2021 Jan 11;16(1):e0244722. doi: 10.1371/journal.pone.0244722. eCollection 2021.

    PubMed 33428667

  • Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019 Aug 16;68(32):698-702. doi: 10.15585/mmwr.mm6832a3.

    PubMed 31415491

  • Garg A, Wheldon CW, Galvin AM, Moore JD, Griner SB, Thompson EL. The Development and Psychometric Evaluation of the Mid-adult Human Papillomavirus Vaccine Knowledge Scale in the United States. Sex Transm Dis. 2022 Jun 1;49(6):423-428. doi: 10.1097/OLQ.0000000000001615. Epub 2022 Feb 8.

    PubMed 35608097

  • Harrison SE, Yelverton V, Wang Y, Ostermann J, Fish LJ, Williams CL, Vasudevan L, Walter EB. Examining Associations between Knowledge and Vaccine Uptake Using the Human Papillomavirus Knowledge Questionnaire (HPV-KQ). Am J Health Behav. 2021 Sep 30;45(5):810-827. doi: 10.5993/AJHB.45.5.2.

    PubMed 34702429

  • Waller J, Ostini R, Marlow LA, McCaffery K, Zimet G. Validation of a measure of knowledge about human papillomavirus (HPV) using item response theory and classical test theory. Prev Med. 2013 Jan;56(1):35-40. doi: 10.1016/j.ypmed.2012.10.028. Epub 2012 Nov 8.

    PubMed 23142106

  • Trevisol FS, Nunes RD, Parma GOC, Manoel AL, Zapelini CM, Trevisol DJ, Traebert J. Internal construct validity of the Brazilian version of a tool for assessing the population's knowledge of human papillomavirus. Rev Bras Epidemiol. 2020 Jun 5;23:e200054. doi: 10.1590/1980-549720200054. eCollection 2020.

    PubMed 32520104

  • Sethi S, Santiago PHR, Soares GH, Ju X, Antonsson A, Canfell K, Smith M, Garvey G, Hedges J, Jamieson L. Development and validation of an HPV infection knowledge assessment scale among Aboriginal and Torres Strait Islander Peoples. Vaccine X. 2023 May 24;14:100317. doi: 10.1016/j.jvacx.2023.100317. eCollection 2023 Aug.

    PubMed 37288370

  • Grace-Leitch L, Shneyderman Y. Using the Health Belief Model to Examine the Link between HPV Knowledge and Self-Efficacy for Preventive Behaviors of Male Students at a Two-Year College in New York City. Behav Med. 2016 Jul-Sep;42(3):205-10. doi: 10.1080/08964289.2015.1121131.

    PubMed 27337625

  • Guvenc G, Seven M, Akyuz A. Health Belief Model Scale for Human Papilloma Virus and its Vaccination: Adaptation and Psychometric Testing. J Pediatr Adolesc Gynecol. 2016 Jun;29(3):252-8. doi: 10.1016/j.jpag.2015.09.007. Epub 2015 Sep 26.

    PubMed 26409648

  • Krawczyk A, Perez S, King L, Vivion M, Dube E, Rosberger Z. Parents' decision-making about the human papillomavirus vaccine for their daughters: II. Qualitative results. Hum Vaccin Immunother. 2015;11(2):330-6. doi: 10.4161/21645515.2014.980708.

    PubMed 25692507

  • Sinshaw MT, Berhe S, Ayele SG. Knowledge and Attitude Towards Human Papillomavirus Vaccine and Associated Factors Among Mothers Who Have Eligible Daughters in Debre Markos Town, Northwest Ethiopia. Infect Drug Resist. 2022 Mar 3;15:781-793. doi: 10.2147/IDR.S352440. eCollection 2022.

    PubMed 35264861

  • Pelullo CP, Di Giuseppe G, Angelillo IF. Human papillomavirus infection: knowledge, attitudes, and behaviors among lesbian, gay men, and bisexual in Italy. PLoS One. 2012;7(8):e42856. doi: 10.1371/journal.pone.0042856. Epub 2012 Aug 8.

    PubMed 22905178

  • Ojeaga A, Alema-Mensah E, Rivers D, Azonobi I, Rivers B. Racial Disparities in HPV-related Knowledge, Attitudes, and Beliefs Among African American and White Women in the USA. J Cancer Educ. 2019 Feb;34(1):66-72. doi: 10.1007/s13187-017-1268-6.

    PubMed 28808906

Questions about this trial

What is this clinical trial studying?

An observational study of Parents and Parent-Child Relations, 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 4 inclusion and 2 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 20 Jun 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 (time frame: one time collected. participants took 15 minutes to complete all items in form.). 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 NCT06466252, which also lists 16 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 20 Jun 2024.

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