NCT07447245

Brief Summary

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide and is the primary cause of cervical cancer. According to World Health Organization (WHO) systems, there were approximately 660,000 new cases of cervical cancer and 350,000 deaths in 2022. In Turkey, the prevalence of cervical cancer was reported as 8,761 in the last five years. HPV vaccines are safe and effective in preventing HPV transmission and cancer and are included in 147 national immunization programs; However, they have not yet been included in the national immunization program in Turkey. The WHO has reissued a regional strategy to eliminate cervical cancer by 2030, which includes vaccinating 90% of girls by age 15, screening 70% of women between the ages of 35 and 45, and increasing the treatment of 90% of precancerous lesions and invasive cervical cancer. The HPV vaccine provides the highest protection before the onset of sexual activity, and ACIP recommends routine vaccination of all 11-12-year-olds (starting at age 9). Catch-up vaccination is recommended for individuals up to age 26 who have not been previously vaccinated. Gardasil and Cervarix vaccines have been licensed in Turkey since 2007; However, vaccination rates are limited by the vaccine not being covered by social security, its cost, the number of doses, and low parental awareness. The safety of HPV vaccines is regularly monitored by international organizations, with approximately 1.7 cases of anaphylaxis per million doses administered.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress56%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

March 3, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 6, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

HPVvaccinepaterneducation

Outcome Measures

Primary Outcomes (1)

  • the human papillomavirus knowledge scale

    General HPV knowledge", with 16 questions on the subjects' general knowledge of HPV. The second subscale, "HPV testing knowledge", has six items related to HPV screening tests. The third subscale, "HPV vaccine knowledge" consists of seven items regarding HPV vaccine information. "HPV vaccine availability" items, the independent HPV-KS subscale, is organized in three different ways for the HPV vaccine program, which is conducted in three countries (the UK, the US, and Australia) where the scale is applied. The independent subscale can be modified to align with each country's HPV vaccine policy. Participants mark each item of the HPV-KS as "Yes", "No", and "I don't know". In the evaluation phase, each correct answer is scored as "1", and wrong answers and "I don't know" statements are scored as "0". The total HPV-KS score may be between "0 and 35". Higher scores indicate a thorough understanding of HPV general knowledge, HPV screening tests, and the HPV vaccine.

    Baseline and 4 weeks

Study Arms (2)

Parent group that will receive HPV training

EXPERIMENTAL

Parents in the experimental group will be asked to remain in the meeting room where they will receive information about HPV and the HPV vaccine, and an educational booklet will be distributed. After the training, they will be asked to answer questions 1, 13, 14, 15, and 16 of the sociodemographic characteristics form again, and the HPV-BÖ (HPV-Vaccine Test) will be administered again. One month later, the same group members will be asked to return to the institution, and they will be informed that invitations will be sent again. A reminder letter containing the date and time of their visit will be sent via their children three days before the measurement date. Parents who cannot attend will be contacted by phone if they wish, and questions 1, 13, 14, 15, and 16 of the sociodemographic characteristics form and the HPV-BÖ will be administered a third time to assess information retention and to inquire about vaccination inclination.

Behavioral: Education about vaccination

Control group to receive HPV training

NO INTERVENTION

Parents in the control group will be thanked for their participation in the study after completing the sociodemographic characteristics form and the HPV-BQ test, and will be informed that they will be asked to return to the institution in one month. A reminder letter (Appendix 7) containing the date and time of their return will be sent via their children three days prior to the measurement date. Parents returning to the institution will have questions 1, 13, 14, 15, and 16 of the sociodemographic characteristics form and the HPV-BQ test administered a second time, and the HPV education previously given to the experimental group will be repeated for the control group on their return date.

Interventions

Parents of children eligible for the HPV vaccine will have their knowledge of HPV assessed and will receive education about the HPV vaccine. Following the education, the parents' knowledge levels and vaccination inclinations will be re-evaluated.

Parent group that will receive HPV training

Eligibility Criteria

Age11 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parent must be between 18-49 years old
  • Parent must be a child aged 11-18
  • Parent must not have hearing or speech problems
  • Parent must be able to read and write in Turkish
  • Parent must agree to participate in the study

You may not qualify if:

  • Parents of children who have received the HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kto Karatay University

Konya, 42020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Funda Gürbüz, Öğr. Gör

CONTACT

Emine GEÇKİL, Prof. Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a pre-test-post-test control group randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2025

First Posted

March 3, 2026

Study Start

February 15, 2026

Primary Completion

June 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

March 3, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations