- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447245
Parent Education About Human Papillomavirus (HPV) ((HPV))
The Effect of Parent Education on Human Papillomavirus Vaccination Intention: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Human papillomavirus (HPV) is one of the leading causes of sexually transmitted infections worldwide. HPV infections spread through direct skin-to-skin contact or skin-to-mucous membrane contact, with sexual contact being the most common form of transmission. Many sexually active individuals are exposed to HPV at some point in their lives. HPV infections are strongly associated with the development of cervical cancer. According to World Health Organization estimates, 660,000 new cases of cervical cancer were diagnosed and 350,000 deaths were recorded in 2022. In Turkey, over the past five years, the prevalence of cervical cancer was reported to be 8,761 and vulvar cancer 977.
HPV vaccines are important in preventing HPV infections. The HPV vaccine is a safe and effective method for preventing the most common HPV infections and HPV-related cancers. Clinical applications of the HPV vaccine have shown that it is highly effective against HPV infection in both genders before their first sexual experience. Over the past decade, HPV vaccines have been included in the national immunization programs of 147 countries. However, the HPV vaccine has not yet been included in the national immunization program in Turkey. Studies have shown that global awareness and knowledge about HPV infection, transmission routes, vaccination, and screening programs are not at an optimal level. H.3. Scope: Human papillomavirus (HPV) is one of the leading causes of sexually transmitted diseases worldwide. HPV infections spread through direct skin-to-skin contact or skin-to-mucous membrane contact, with sexual contact being the most common form of transmission. Many sexually active individuals are exposed to HPV at some point in their lives.
HPV infections are strongly associated with the development of cervical cancer. According to World Health Organization estimates, 660,000 new cases of cervical cancer were diagnosed and 350,000 deaths were recorded in 2022. In Turkey, over the past five years, the prevalence of cervical cancer was reported to be 8,761 and vulvar cancer 977. HPV vaccines are important in preventing HPV infections. The HPV vaccine is a safe and effective method for preventing the most common HPV infections and HPV-related cancers. Clinical applications of the HPV vaccine have shown it to be highly effective against HPV infection in both sexes before their first sexual experience.
Over the past decade, HPV vaccines have been included in the national immunization programs of 147 countries. However, the HPV vaccine has not yet been included in Turkey's national immunization program. Studies have reported that global awareness and knowledge about HPV infection, transmission routes, vaccination, and screening programs are not at an optimal level. In May 2018, the World Health Organization issued a global call to action to all member stakeholders to eliminate cervical cancer. This call stated that if no action is taken, mortality rates from cervical cancer are expected to increase by nearly 50% by 2040. In this context, global strategies for the prevention of cervical cancer by 2030 were defined at the "73rd World Health Assembly" in November 2020, with the participation of 194 WHO member countries. These strategies are based on three key pillars: vaccine-based prevention, screening and treatment of precancerous lesions, and treatment of invasive cervical cancer and palliative care. Based on these three pillars, the WHO has set the following targets for eliminating cervical cancer in every country by 2030.
Vaccination: Full vaccination of 90% of girls (up to age 15) with the HPV vaccine. Screening: Screening of 70% of women up to age 35 and repeating these screening tests up to age 45. Treatment: Treatment of 90% of women diagnosed with cervical cancer (defined as treatment of 90% of precancerous lesions and management of 90% of invasive cervical cancer cases). A person is at risk of HPV infection the first time they have sexual intercourse. Therefore, for the HPV vaccine to be most effective, it is important that it is administered before exposure to HPV and before the onset of sexual activity. In this context, the Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all girls and boys aged 11 or 12 (starting at age 9) before they become sexually active. When vaccines are administered between the ages of 9 and 14, a higher rate of antibody response
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Funda Gürbüz, Öğr. Gör
- Phone Number: 05065005321
- Email: funda.gurbuz@karatay.edu.tr
Study Contact Backup
- Name: Emine GEÇKİL, Prof. Dr
- Email: eminegeckil@gmail.com
Study Locations
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Konya, Turkey (Türkiye), 42020
- Recruiting
- KTO Karatay University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• Parents of children who have received the HPV vaccine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Parent group that will receive HPV training
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.
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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.
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No Intervention: Control group to receive HPV training
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the human papillomavirus knowledge scale
Time Frame: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Pathological Conditions, Signs and Symptoms
- Papillomavirus Infections
Other Study ID Numbers
- KTO Karatay Ünivesitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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