Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-03-03 @ 3:39 AM
Study NCT ID:
NCT07097766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Health Belief Model-Based Education and Motivational Interviewing on HPV (Human Papilloma Virus) Knowledge and Vaccine Awareness in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV Knowledge Score', 'timeFrame': '4 weeks after the intervention', 'description': "Participants' total score on an HPV knowledge questionnaire designed to assess understanding of HPV infection, transmission, and prevention."}], 'secondaryOutcomes': [{'measure': 'HPV Vaccination Awareness Score', 'timeFrame': '4 weeks after the intervention', 'description': "Participants' awareness level regarding HPV vaccination, measured using a structured 10-item survey."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV', 'Human Papillomavirus', 'HPV Vaccine', 'Health Belief Model', 'Motivational Interviewing', 'Vaccine Awareness', 'Women's Health', 'Cervical Cancer Prevention'], 'conditions': ['Human Papillomavirus Infection']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "This randomized controlled trial is designed to assess the impact of education and motivational interviewing grounded in the Health Belief Model (HBM) on women's knowledge regarding HPV and awareness of the HPV vaccine. The study population consists of 18-45-year-old literate women who have not previously received HPV vaccination.\n\nParticipants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a 3-session structured education program based on HBM constructs (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy), supported by motivational interviewing techniques. The control group will receive no intervention.\n\nData collection will include pre- and post-intervention assessments using a validated HPV knowledge scale and vaccine awareness questionnaire. The expected outcome is a statistically significant improvement in knowledge and awareness in the intervention group.\n\nThis study aims to contribute to public health efforts in HPV prevention and vaccination promotion by utilizing a behavioral model in community education."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'only individuals who identify as female and meet the age criteria will be eligible to participate in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 18-45 years\n\nVoluntary participation and providing informed consent\n\nNot previously vaccinated against HPV\n\nAbility to attend all three educational and motivational interview sessions\n\nLiteracy sufficient to complete study questionnaires\n\nExclusion Criteria:\n\n* Women under 18 or over 45 years old\n\nPrior HPV vaccination\n\nCognitive or psychiatric conditions that hinder participation\n\nCurrently participating in another HPV-related education or intervention study\n\nInability to attend all sessions of the intervention program'}, 'identificationModule': {'nctId': 'NCT07097766', 'acronym': 'HPV', 'briefTitle': 'The Effect of Health Belief Model-Based Education and Motivational Interviewing on HPV (Human Papilloma Virus) Knowledge and Vaccine Awareness in Women', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Health Belief Model-Based Education and Motivational Interviewing on Human Papillomavirus (HPV) Infection Knowledge Level and HPV Vaccine Awareness Among Women', 'orgStudyIdInfo': {'id': 'SAYYILDIZ2025HPV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Behavioral: "HBM-Based Education and Motivational Interviewing"']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': '"HBM-Based Education and Motivational Interviewing"', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Üsküdar', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'seda Ayyıldız, PhD(c)', 'role': 'CONTACT', 'email': 'sedaoltulu_89@hotmail.com', 'phone': '+905533187315'}], 'facility': 'Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.02274, 'lon': 29.01366}}], 'centralContacts': [{'name': 'seda Ayyıldız, doctora student', 'role': 'CONTACT', 'email': 'sedaoltulu_89@hotmail.com', 'phone': '+905533187315'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD and supporting documents will be available starting 6 months after the publication of the study results and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': 'IPD and supporting documents will be available starting 6 months after the publication of the primary study results and will remain available for 5 years.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seda Ayyıldız (Doctoral Student)', 'investigatorFullName': 'Seda Ayyıldız', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}