HPV (Human Papillomavirus)-AssociatedNCT07447245
Parent Education About Human Papillomavirus (HPV)
A study testing Behavioral: Health Belief Model-Based HPV Education in people with HPV (Human Papillomavirus)-Associated, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV (Human Papillomavirus)-Associated
- What is being tested?
- Behavioral: Health Belief Model-Based HPV Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Having a child who had received any dose of the HPV vaccine before enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Health Belief Model-Based Parent Education Intervention on Human Papillomavirus Knowledge and Vaccination Intention: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- HPV (Human Papillomavirus)-Associated
- Being tested
- Behavioral: Health Belief Model-Based HPV Education
- Keywords
- HPV, vaccine, patern, education
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Health Belief Model-Based HPV EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent group that will receive HPV training | Experimental | 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 session lasted approximately 40 minutes and included information on HPV transmission, HPV-related cancers, HPV vaccination, vaccine effectiveness, vaccination schedules, screening, and common misconceptions. Participants were invited to return five weeks later for post-intervention assessment. Receives: Behavioral: Behavioral: Health Belief Model-Based HPV Education |
| Control group to receive HPV training | No intervention | Participants assigned to the control group completed the baseline assessment and received no educational intervention during the five-week comparison period. They returned five weeks later for post-intervention assessment. After completion of the post-intervention assessment, they received the same educational session as the intervention group for ethical reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papillomavirus Knowledge Scale (HPV-KS)
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.
Measured: Baseline and 5 weeks
Secondary outcomes (1)
HPV Vaccination Intention
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.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start25 Feb 2026
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV (Human Papillomavirus)-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a pre-test-post-test control group randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447245
- Sponsor's protocol ID
- KTO Karatay Ünivesitesi
- Status last verified
- Aug 2026
- First submitted
- 6 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations. Aggregated study results will be reported in the publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Health Belief Model-Based Parent Education Intervention on Human Papillomavirus Knowledge and Vaccination Intention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07447245
- Acronym / sponsor ID
- KTO Karatay Ünivesitesi
- Conditions
- HPV (Human Papillomavirus)-Associated
- Keywords
- HPV, vaccine, patern, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a pre-test-post-test control group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Parent group that will receive HPV training | Experimental | Behavioral: Behavioral: Health Belief Model-Based HPV EducationParticipants 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 session lasted approximately 40 minutes and included information on HPV transmission, HPV-related cancers, HPV vaccination, vaccine effectiveness, vaccination schedules, screening, and common misconceptions. Participants were invited to return five weeks later for post-intervention assessment. |
| Control group to receive HPV training | No intervention | –Participants assigned to the control group completed the baseline assessment and received no educational intervention during the five-week comparison period. They returned five weeks later for post-intervention assessment. After completion of the post-intervention assessment, they received the same educational session as the intervention group for ethical reasons. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Having a child who had received any dose of the HPV vaccine before enrollment in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Health Belief Model-Based HPV EducationParticipants 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. | Behavioural | Parent group that will receive HPV training |
Primary outcome
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.
1 secondary outcome
HPV Vaccination Intention
Time frame: Baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations. Aggregated study results will be reported in the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Health Belief Model-Based HPV Education in people with HPV (Human Papillomavirus)-Associated, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papillomavirus Knowledge Scale (HPV-KS) (time frame: Baseline and 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.