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Completed

NCT Number: NCT07447245

Parent Education About Human Papillomavirus (HPV)

Human papillomavirus (HPV) vaccination is an effective strategy for preventing HPV-related diseases; however, parental knowledge and vaccination intention may influence vaccine uptake among children and adolescents. This randomized controlled trial evaluated the effect of a Health Belief Model (HBM)-based parent education intervention on HPV knowledge and HPV vaccination intention among parents of children aged 9-14 years.

A total of 64 parents were enrolled and randomly assigned to an intervention group (n=32) or a control group (n=32). Following baseline assessment, the intervention group received a single, approximately 40-minute, face-to-face, nurse-led educational session based on the constructs of the Health Belief Model. The control group received no educational intervention during the five-week comparison period.

HPV knowledge and vaccination intention were assessed at baseline and five weeks later. After completion of the five-week assessment, the control group received the same educational session for ethical reasons.

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Key information

About this study

This parallel-group randomized controlled trial was conducted among parents of children aged 9-14 years. A total of 64 eligible parents completed the baseline assessment and were allocated to two parallel groups, with 32 participants in the intervention group and 32 participants in the control group.

Following the baseline assessment, participants assigned to the intervention group received a single, face-to-face, nurse-led educational session based on the Health Belief Model. The approximately 40-minute session addressed HPV transmission, HPV-related diseases and cancers, HPV vaccination, vaccine effectiveness, recommended vaccination schedules, screening, common misconceptions, and barriers to vaccination. The educational content was structured according to the Health Belief Model constructs of perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.

Participants in both groups were invited to return five weeks after the baseline assessment. To reduce interaction between groups during follow-up assessment, the intervention and control groups attended at different times on the same day. The intervention group attended first, followed by the control group. HPV knowledge and vaccination intention were reassessed at the five-week follow-up.

All 32 participants in the intervention group completed the follow-up assessment. Of the 32 participants assigned to the control group, 30 completed the follow-up assessment. After completion of the follow-up assessment, participants in the control group received the same educational session provided to the intervention group.

Who can participate

Healthy volunteers accepted: Yes

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

Parent aged 18-49 years

  • Being a parent of a child aged 9-14 years
  • Being able to read and write in Turkish
  • Having no hearing or communication problems that would prevent participation in the educational session
  • Providing voluntary informed consent to participate in the study

Exclusion criteria

  • Having a child who had received any dose of the HPV vaccine before enrollment in the study

Treatment and study plan

Behavioral: Health Belief Model-Based HPV Education

Behavioral

Participants assigned to the intervention group received a single, face-to-face, nurse-led educational session based on the Health Belief Model after completion of the baseline assessment. The approximately 40-minute session addressed HPV transmission, HPV-related cancers, HPV vaccination, vaccine effectiveness, recommended vaccination schedules, screening, and common misconceptions. The educational content was structured according to the Health Belief Model constructs, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. Participants were invited to return five weeks later for post-intervention assessment.

Primary outcomes

  1. Human Papillomavirus Knowledge Scale (HPV-KS)

    Time frame: Baseline and 5 weeks

    HPV knowledge was assessed using the 33-item Human Papillomavirus Knowledge Scale (HPV-KS). The scale includes items assessing general HPV knowledge, HPV testing knowledge, and HPV vaccination knowledge. Items are answered as "Yes," "No," or "I don't know." Each correct response is scored as 1, whereas incorrect and "I don't know" responses are scored as 0. Total scores range from 0 to 33, with higher scores indicating greater HPV-related knowledge.

Secondary outcomes

  1. HPV Vaccination Intention

    Time frame: Baseline and 5 weeks

    Parents' intention to vaccinate their child against HPV was assessed using the question, "Would you consider vaccinating your child against HPV?" Responses were recorded as "Yes" or "No." Vaccination intention was assessed at baseline and again five weeks after the intervention.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

Effect of a Health Belief Model-Based Parent Education Intervention on Human Papillomavirus Knowledge and Vaccination Intention: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Aug 10, 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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