- 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)
Effect of a Health Belief Model Based Education Program on Women's Cervical Cancer Knowledge and HPV Vaccination Attitudes in Primary Care Settings: A Quasi-Experimental Pre-test-Posttest Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This study was a quasi-experimental pretest-posttest controlled intervention designed to evaluate the effectiveness of a Health Belief Model (HBM)-based educational program on women's cervical cancer knowledge and HPV vaccination attitudes in a primary care setting. The study was conducted at the Tusba Training Family Health Center in Van, Türkiye, between March 2026 and May 2026.
The study population consisted of women aged 18-49 years attending the Tusba Training Family Health Center. Women who met the inclusion criteria and provided written informed consent were enrolled in the study. A total of 154 participants were assigned to the intervention (n = 77) and control (n = 77) groups using a systematic allocation approach based on the order of admission. Baseline data were collected using a Participant Information Form, the Cervical Cancer Knowledge Scale, and the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS).
The intervention group received a structured educational program based on the Health Belief Model. The program consisted of two face-to-face sessions lasting approximately 30-40 minutes each. The educational content included information on cervical cancer, risk factors, screening methods, HPV infection, HPV vaccination, and common misconceptions. The program was structured around the key constructs of the Health Belief Model, including perceived susceptibility, perceived severity, perceived benefits, and perceived barriers.
The control group received routine primary health care services without any additional structured educational intervention.
Post-intervention data were collected approximately 15 days after completion of the educational program using the same measurement instruments. The data were analyzed using appropriate statistical methods, including descriptive statistics and comparative tests for within-group and between-group differences. Statistical significance was set at p < 0.05.
The study did not involve any invasive procedures, biological sample collection, or pharmaceutical interventions. All study procedures were conducted in accordance with ethical principles, and participant confidentiality was maintained throughout the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Van
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Van, Van, Turkey (Türkiye), 65100
- Tusba Training Family Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18-49 years
- Applied to a Family Health Center
- Parents of adolescent girls (aged 10-18 years)
- Able to read and write Turkish
- Voluntarily agreed to participate in the study
- Provided written informed consent
Exclusion Criteria:
- Previous HPV vaccination
- Diagnosis of cervical cancer
- Cognitive or psychiatric disorders that interfered with communication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Participants received a structured face-to-face Health Belief Model-based educational program consisting of two sessions.
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A structured face-to-face educational program based on the Health Belief Model consisting of two sessions (30-40 minutes each) covering cervical cancer, HPV infection, cervical cancer screening, HPV vaccination, common misconceptions, and the key Health Belief Model constructs, including perceived susceptibility, perceived severity, perceived benefits, and perceived barriers.
|
|
No Intervention: No Intervention
Participants received routine primary health care services without additional structured educational intervention.
|
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.
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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.
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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 (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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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