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Human Papillomavirus (HPV)NCT07248904

The Effect of a Transtheoretical Model-Based Educational Intervention on First-Year Nursing Students' HPV Knowledge, Health Beliefs, and Vaccination Behavior Intentions

A study testing TTM-Based Educational Program in people with Human Papillomavirus (HPV) and Papillomavirus Vaccines, run by Cukurova University at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to examine the impact of a structured educational program based on the Transtheoretical Model (TTM) on HPV knowledge, health beliefs, and vaccination behavioral intentions among first-year nursing students. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
TTM-Based Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesTurkey (Türkiye)
Study dates
16 Jan 2026to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • First-year students enrolled in the Nursing Department of the Faculty of Health Sciences
  • Provide written informed consent to participate
  • Agree to attend all educational sessions and data collection appointments during the study period
  • Have sufficient Turkish literacy to read and understand study materials
  • Have not previously received any comprehensive education about HPV infection or HPV vaccination

Who cannot join

  • Students who do not agree to participate in the study
  • Students who do not provide written informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

MÜJDE KERKEZ, Asist. Prof. Dr contact

+905059718697

mujjde_@hotmail.com

Turkey (Türkiye)2 sites, 2 recruiting

  • Faculty of Health Sciences

    Adana, CUKUROVA

    MÜJDE KERKEZ, +905059718697, mujjde_@hotmail.com

    Not yet recruiting

  • Cukurova University

    Adana

    MÜJDE KERKEZ, Asist.Prof., mujjde_@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

The purpose of this study is to examine the impact of a structured educational program based on the Transtheoretical Model (TTM) on HPV knowledge, health beliefs, and vaccination behavioral intentions among first-year nursing students. The study will also evaluate how the intervention affects students' HPV vaccine readiness compared to the TTM.

The primary questions addressed by the study are:

Read more
  • Does the TTM-based educational intervention increase students' knowledge about HPV and the HPV vaccine?
  • Does the program change students' health beliefs regarding susceptibility, severity, benefits, and barriers to HPV and the HPV vaccine?
  • Does the program improve students' intentions and readiness to receive the HPV vaccine?
  • Do students move to a higher behavioral readiness stage (from Precontemplation to Contemplation, Preparation, Action, or Maintenance) after the intervention?

The researcher will compare the TTM-based educational intervention with a control group that did not receive structured education to determine whether a personalized, stage-based approach is more effective in improving HPV-related outcomes among nursing students.

Participants will:

  • Complete baseline questionnaires measuring HPV knowledge, health beliefs, and vaccination intention.
  • The experimental group (intervention group) will receive personalized TTM-based education, face-to-face instruction in modules aligned with the five TTM phases (Precontemplation, Contemplation, Preparation, Action, and Maintenance).
  • The experimental group will participate in educational sessions designed to raise awareness, correct misinformation, support decision-making, and encourage protective behaviors.
  • The control group will not receive any educational program.
  • All participants in the experimental and control groups will complete the same questionnaires again to assess changes after the intervention.

The TTM-based educational intervention provides:

  • Staged counseling
  • Information about HPV and the HPV vaccine
  • Activities to raise awareness, strengthen motivation, and support vaccination adoption
  • Personalized feedback based on student readiness
  • Structured modules focusing on knowledge, belief, and behavior change strategies

The study population included first-year nursing students enrolled in the Faculty of Health Sciences. A total of 88 participants will be recruited and randomly assigned to either the intervention (n=44) or control (n=44) groups through simple randomization.

The results of this study are expected to contribute to the development of evidence-based education strategies in nursing, support of behavioral change models in health education, and strengthen the role of future nurses in HPV prevention, vaccine advocacy, and public health practice.

Being tested
TTM-Based Educational Program
Medical subject headings
Behavior, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTM-Based Educational ProgramBehavioural

    A structured, stage-matched educational intervention based on the Transtheoretical Model, delivered face-to-face in five modules aligned with Precontemplation, Contemplation, Preparation, Action, and Maintenance stage

Study groups in NCT07248904
Study groupRoleWhat they receive
Intervention GroupExperimentalTTM-based structured educational program tailored to the participant's stage of readiness for HPV vaccination
Receives: Behavioral: TTM-Based Educational Program
Control GroupNo interventionNo structured education; participants receive no TTM-based training during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccination Behavior Intention Scale

    Behavioral intention to receive the HPV vaccine will be assessed using the HPV Vaccination Intention Scale, a 6-item instrument developed based on the Theory of Planned Behavior. The scale evaluates participants' intention to receive the HPV vaccine, with higher scores indicating stronger intention to be vaccinated. The secondary outcome is the change in intention score from baseline to post-intervention.

    Measured: Baseline and after completion of the 10-week intervention (5 sessions delivered every 2 weeks)

Secondary outcomes (2)

  1. HPV Knowledge Scale

    HPV knowledge will be measured using the HPV Knowledge Scale (HPV-BS), a validated 33-item instrument consisting of four subscales: general HPV knowledge (16 items), HPV screening knowledge (6 items), HPV vaccine knowledge (5 items), and HPV vaccination program knowledge (6 items). Total scores range from 0 to 35, with higher scores indicating greater knowledge about HPV infection, transmission, screening, and vaccination. A Cronbach's alpha coefficient of 0.96 was reported in the Turkish validity and reliability study. The primary outcome is the change in total HPV knowledge score from baseline to postintervention.

    Measured: Baseline and after completion of the 10-week intervention (5 sessions delivered every 2 weeks)

  2. Health Belief Model Scale regarding HPV and vaccination

    Health beliefs regarding HPV and HPV vaccination will be measured using the Health Belief Model Scale (HBM-HPV), a validated instrument developed by Kim (2016) and adapted into Turkish by Guvenc et al. (2016). The scale consists of four subscales: perceived benefits (items 1-3), perceived susceptibility (items 4-5), perceived severity (items 6-9), and perceived barriers (items 10-13 and 15). Higher scores indicate stronger beliefs within each construct. Except for perceived barriers, all subscales are positively associated with HPV vaccination intention. Cronbach's alpha values for the subscales range from 0.71 to 0.78. The secondary outcome is the change in subscale scores from baseline to post-intervention.

    Measured: Baseline and after completion of the 10-week intervention (5 sessions delivered every 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start16 Jan 2026
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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 uses a parallel-group randomized controlled design. Participants are first-year nursing students who will be randomly assigned, using simple randomization, to either the intervention group or the control group. The intervention group will receive a Transtheoretical Model (TTM)-based structured educational program tailored to the participant's stage of readiness for HPV vaccination. The control group will receive no structured education during the study period. Both groups will complete baseline and post-intervention assessments measuring HPV knowledge, health beliefs, and vaccination intention. The model allows comparison of outcomes between groups to evaluate the effectiveness of the stage-based educational intervention.
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07248904
Sponsor's protocol ID
TTM-HPV-001
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the study involves identifiable student information, and sharing raw data may pose confidentiality and privacy risks. Data will be stored securely and used only for the purposes approved by the ethics committee. Only aggregated and de-identified results will be reported in publications.

Questions about this trial

What is this clinical trial studying?

A study testing TTM-Based Educational Program in people with Human Papillomavirus (HPV) and Papillomavirus Vaccines, run by Cukurova University at 2 sites 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MÜJDE KERKEZ, Asist. Prof. Dr (+905059718697, mujjde_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccination Behavior Intention Scale (time frame: Baseline and after completion of the 10-week intervention (5 sessions delivered every 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07248904.

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 27 Mar 2026.

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