NCT07248904

Brief 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. 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:

  • 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 27, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 18, 2025

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • HPV Knowledge Scale

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

  • Health Belief Model Scale regarding HPV and vaccination

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

TTM-based structured educational program tailored to the participant's stage of readiness for HPV vaccination

Behavioral: TTM-Based Educational Program

Control Group

NO INTERVENTION

No structured education; participants receive no TTM-based training during the study period.

Interventions

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

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Health Sciences

Adana, CUKUROVA, Turkey (Türkiye)

NOT YET RECRUITING

Cukurova University

Adana, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

BehaviorHealth Behavior

Central Study Contacts

MÜJDE KERKEZ, Asist. Prof. Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof. Dr.

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

January 16, 2026

Primary Completion

March 30, 2026

Study Completion

April 30, 2026

Last Updated

March 27, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations