- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521163
Effect of Health Belief Model-Based Education on Cervical Cancer Knowledge and HPV Vaccine Attitudes in Women (HBM-HPV)
The Effect of a Health Belief Model-Based Educational Intervention on Women's Knowledge of Cervical Cancer and Their Attitudes and Beliefs Toward HPV Vaccination: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a quasi-experimental pretest-posttest controlled intervention designed to assess the effectiveness of a Health Belief Model (HBM)-based educational program on cervical cancer knowledge and HPV vaccination attitudes among women. The study will be conducted in a primary health care setting in Van, Turkey.
The study population consists of women aged 18-49 years who attend the Tusba Training Family Health Center. Participants who meet the inclusion criteria and provide informed consent will be included. The sample size is planned to include at least 100 participants, with approximately equal numbers in the intervention and control groups.
Participants will be assigned to intervention and control groups using a systematic allocation approach based on order of admission. Before the intervention, baseline data will be collected using a Participant Information Form, a Cervical Cancer Knowledge Scale, and the Carolina HPV Immunization Attitudes and Beliefs Scale.
The intervention group will receive a structured educational program based on the Health Belief Model. The program consists of two sessions lasting approximately 30-40 minutes each and will be delivered face-to-face. The content includes information about cervical cancer, risk factors, screening methods, HPV infection, HPV vaccination, and common misconceptions. The educational content is structured around key HBM constructs, including perceived susceptibility, perceived severity, perceived benefits, and perceived barriers.
The control group will receive routine health care services without additional educational intervention.
Post-test data will be collected approximately 15 days after the intervention using the same measurement tools. Data will be analyzed using appropriate statistical methods, including descriptive statistics and comparative tests for within-group and between-group differences. Statistical significance will be set at p < 0.05.
The study does not involve any invasive procedures, biological sample collection, or pharmaceutical interventions. All procedures will be conducted in accordance with ethical principles, and participant confidentiality will be maintained throughout the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammet Faruk Yiğit, PhD
- Phone Number: +90 542 424 76 29
- Email: muhammed-1466@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18-49 years
- Attending the Tusba Training Family Health Center
- Able to read and write Turkish
- Willing to participate in the study
- Provided written informed consent
Exclusion Criteria:
- Having received HPV vaccination previously
- History of cervical cancer
- Presence of severe psychiatric, cognitive, or communication disorders
- Inability to attend the educational sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Participants will receive a Health Belief Model-based structured face-to-face educational program consisting of two sessions.
|
A structured face-to-face educational program on cervical cancer, HPV infection, screening, HPV vaccination, and common misconceptions based on the Health Belief Model.
|
|
No Intervention: No Intervention
Participants will receive routine primary health care services without additional structured education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cervical Cancer Knowledge Score
Time Frame: Baseline and 15 days post-intervention
|
Change in participants' knowledge of cervical cancer was assessed using the Cervical Cancer Knowledge Scale.
The scale consists of 20 items, with total scores ranging from 0 to 20, where higher scores indicate greater knowledge about cervical cancer.
Measurements were conducted before the educational intervention and 15 days after the intervention.
|
Baseline and 15 days post-intervention
|
|
Change in HPV Vaccination Attitudes and Beliefs Score
Time Frame: Baseline and 15 days post-intervention
|
Change in participants' attitudes and beliefs toward HPV vaccination was assessed using the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS).
The scale consists of 16 items rated on a 4-point Likert scale, with total scores ranging from 16 to 64, where higher scores indicate more negative attitudes and beliefs toward HPV vaccination.
Measurements were conducted before the intervention and 15 days after the intervention.
|
Baseline and 15 days post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to human papillomavirus vaccination among US adolescents: a systematic review of the literature. JAMA Pediatr. 2014 Jan;168(1):76-82. doi: 10.1001/jamapediatrics.2013.2752.
- Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Infections
- Virus Diseases
- Uterine Diseases
- Genital Diseases, Female
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Tumor Virus Infections
- Pathological Conditions, Signs and Symptoms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Uterine Cervical Neoplasms
- Papillomavirus Infections
- Health Education
Other Study ID Numbers
- 09.03.2026-238631
- EA-2026-5244 (Other Identifier: Mus Alparslan University Scientific Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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