The Effect of Health Belief Model-Based Education and Motivational Interviewing on HPV (Human Papilloma Virus) Knowledge and Vaccine Awareness in Women

NCT07097766 | Not Yet Recruiting DMC

• 1 other identifier: SAYYILDIZ2025HPV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of an educational intervention based on the Health Belief Model (HBM) combined with motivational interviewing on women's knowledge about Human Papillomavirus (HPV) infection and their awareness of HPV vaccination. The study will be conducted among women aged 18-45 who have not received the HPV vaccine. Participants in the intervention group will receive structured education and motivational interviews, while the control group will receive no intervention. Changes in HPV knowledge and vaccine awareness will be measured before and after the intervention using validated scales. The goal is to improve preventive behaviors and increase vaccine uptake through behavior-based education.

Conditions

Human Papillomavirus Infection

Keywords

HPV; Human Papillomavirus; HPV Vaccine; Health Belief Model; Motivational Interviewing; Vaccine Awareness; Women's Health; Cervical Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• HPV Knowledge Score

  Participants' total score on an HPV knowledge questionnaire designed to assess understanding of HPV infection, transmission, and prevention.

  4 weeks after the intervention

Secondary Outcomes (1)

• HPV Vaccination Awareness Score

  4 weeks after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: "HBM-Based Education and Motivational Interviewing"

Control Group

NO INTERVENTION

This group will not receive any educational intervention or motivational interviewing. Standard care or routine health information will be provided as per usual practice.

Interventions

"HBM-Based Education and Motivational Interviewing" BEHAVIORAL

This intervention consists of a structured 3-session educational program and motivational interviews based on the Health Belief Model (HBM). It aims to increase knowledge about HPV infection and improve HPV vaccination awareness among women aged 18-45.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only individuals who identify as female and meet the age criteria will be eligible to participate in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18-45 years
• Voluntary participation and providing informed consent
• Not previously vaccinated against HPV
• Ability to attend all three educational and motivational interview sessions
• Literacy sufficient to complete study questionnaires

You may not qualify if:

• Women under 18 or over 45 years old
• Prior HPV vaccination
• Cognitive or psychiatric conditions that hinder participation
• Currently participating in another HPV-related education or intervention study
• Inability to attend all sessions of the intervention program

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi

Üsküdar, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

seda Ayyıldız, doctora student

CONTACT

+905533187315; sedaoltulu_89@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors were blinded to group assignments. However, the intervention provider was aware of group allocation due to the nature of the educational intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seda Ayyıldız (Doctoral Student)

Model Details: Participants will be randomly assigned to either an intervention group receiving HBM-based education and motivational interviewing, or a control group receiving no intervention. Outcomes will be assessed before and after the intervention.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available starting 6 months after the publication of the study results and will remain available for 5 years.
• Access Criteria: Qualified researchers may request access to the individual participant data by contacting the principal investigator. Access will be granted upon reasonable request and approval of a data sharing agreement.

Locations

TU (1)