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NCT Number: NCT07447245

Parent Education About Human Papillomavirus (HPV)

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.

Recruiting

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Key information

Age range

11 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kto Karatay University

Konya, 42020, Turkey (Türkiye)

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education about vaccination

Behavioral

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.

Primary outcomes

  1. the human papillomavirus knowledge scale

    Time frame: Baseline and 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emine GEÇKİL, Prof. Dr

CONTACT

[email protected]

Funda Gürbüz, Öğr. Gör

CONTACT

[email protected]

05065005321

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

The Effect of Parent Education on Human Papillomavirus Vaccination Intention: A Randomized Controlled Trial

Acronym: (HPV)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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