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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06466252
Other study ID # 421/061/404.102.28/II/2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date May 1, 2023

Study information

Verified date June 2024
Source Kaohsiung Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 673
Est. completion date May 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - parents had mental, visual, and hearing impairments or problems diagnosed by doctors - their children' age are over 14 years old.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychometric Group
There are no interventions

Locations

Country Name City State
Indonesia Elementary school Ngawi East Java

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

Forster AS, McBride KA, Davies C, Stoney T, Marshall H, McGeechan K, Cooper SC, Skinner SR. Development and validation of measures to evaluate adolescents' knowledge about human papillomavirus (HPV), involvement in HPV vaccine decision-making, self-effica — View Citation

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.000 — View Citation

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: 10.1080/0 — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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; — View Citation

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/I — View Citation

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. — View Citation

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. — View Citation

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 No — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one time collected. participants took 15 minutes to complete all items in form.
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