Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:18 PM
Study NCT ID:
NCT07420556
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different HPV Education Methods on Vaccination Intention in Young Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking was not possible due to the nature of the intervention; this is an open-label study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of three parallel groups: a control group, a video-based education group, or a face-to-face education group. Each participant will remain in the assigned group throughout the study, and outcomes will be compared between groups across three measurement time points (baseline, immediately after the intervention, and one-month follow-up).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV Knowledge and Vaccination Intention - Pre-Test', 'timeFrame': 'Before education', 'description': "Young women who consent to participate in the study will complete the Participant Information Form and the HPV Knowledge and Vaccination Intention Scale before receiving any education. This stage aims to determine participants' baseline knowledge and intention to vaccinate."}], 'secondaryOutcomes': [{'measure': 'HPV Knowledge and Vaccination Intention - Post-Education Test', 'timeFrame': 'Immediately after education', 'description': 'Immediately after the intervention, the experimental groups will receive the designated educational methods (video-based education and face-to-face education), and the same scales will be re-administered. This measurement is intended to evaluate the short-term effect of the education. The control group will not receive any education at this stage, only the assessments will be conducted.'}, {'measure': 'HPV Knowledge and Vaccination Intention - 1-Month Follow-Up Test', 'timeFrame': ': 1 month after education', 'description': 'One month after the educational intervention, all groups will complete the same scales again to assess the persistence of changes in knowledge and vaccination intention. This measurement evaluates the sustained effect of the educational interventions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV', 'HPV vaccination', 'HPV vaccine acceptance', 'preventive health behavior', 'health education'], 'conditions': ['Human Papillomavirus (HPV) Infection', 'HPV Vaccination Acceptance/Intention']}, 'descriptionModule': {'briefSummary': 'Detailed Description Human papillomavirus (HPV) is one of the leading causes of cervical cancer and can be prevented by vaccination. However, HPV vaccination rates among young women are low, largely due to insufficient knowledge and misconceptions about HPV and the vaccine. Therefore, an effective educational program may improve both knowledge and vaccination intention.\n\nThe aim of this randomized controlled trial is to examine the effect of delivering HPV education through different methods (asynchronous online education delivered via a pre-recorded video and face-to-face education) on HPV knowledge level and HPV vaccination intention among women aged 18-24 years.\n\nThe study will be conducted with women aged 18-24 years registered at Family Health Centers in the Afşin district of Kahramanmaraş, Türkiye. Eligible participants will be randomly assigned into three groups: the video-based education group, the face-to-face education group, and the control group.\n\nData will be collected using the Participant Information Form, HPV Knowledge Scale, and HPV Vaccination Attitude and Intention Form. Measurements will be performed at three time points: before the education (pre-test), immediately after the education (post-test), and one month after the education (follow-up test). The video-based education group will receive the education via a pre-recorded online video, while the face-to-face group will receive the same content in person at the Family Health Center. No education will be provided to the control group; only measurements will be obtained.\n\nResearch Questions\n\nDoes HPV education delivered through different methods increase HPV knowledge levels among young women?\n\nDoes HPV education increase HPV vaccination intention compared with the control group?\n\nIs face-to-face education more effective than video-based education in increasing vaccination intention?\n\nAre the improvements in knowledge and vaccination intention sustained one month after the education?', 'detailedDescription': "This study is a randomized controlled intervention designed to evaluate the effects of different educational methods on HPV and HPV vaccination knowledge level and vaccination intention among young women aged 18-24 living in the Afşin district of Kahramanmaraş, Türkiye. Participants will be randomly assigned into three groups: control group, video-based education group, and face-to-face education group.\n\nAt the beginning of the study, a pre-test will be administered to determine participants' baseline HPV and HPV vaccine knowledge and vaccination intention. Educational interventions prepared in accordance with national health guidelines will be delivered to the intervention groups, while no training will be provided to the control group. Immediately after the education sessions, a post-test will be applied to assess short-term effects, and a follow-up assessment one month later will evaluate the persistence of the effect.\n\nData will be collected at three time points using an introductory information form, the HPV Knowledge Scale, and the HPV Vaccination Attitude and Intention Form. The findings will be used to compare the effectiveness of different educational methods on HPV knowledge level and vaccination intention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only individuals who are biologically female, identify as female, and are aged 18-24 years are eligible to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included in the study:\n\nAged 18-24 years,\n\nResiding in Afşin district, Kahramanmaraş province,\n\nWilling to voluntarily participate in the study,\n\nLiterate and able to understand survey questions in Turkish,\n\nHave not previously received the HPV vaccine,\n\nAgree to be available throughout the study period (pre-test, post-education test, and 1-month follow-up test),\n\nYoung women without physical or cognitive impairments or serious health problems that would prevent participation in the study.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following conditions:\n\nUnder 18 or over 24 years of age,\n\nHave received the HPV vaccine or started the vaccine series,\n\nHave been diagnosed with HPV infection,\n\nUnable to attend the educational sessions or complete all stages of data collection (pre-test, post-education test, 1-month follow-up test),\n\nIlliterate or unable to understand the study forms in Turkish,\n\nWithdraw from the study or indicate unwillingness to continue participation,\n\nHave serious hearing, vision, or cognitive impairments that would prevent meaningful engagement in the educational sessions.'}, 'identificationModule': {'nctId': 'NCT07420556', 'briefTitle': 'Effect of Different HPV Education Methods on Vaccination Intention in Young Women', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': "The Effect of Delivering HPV Education Through Different Methods on Young Women's Intention to Receive the Vaccine: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'HPV-EDU-2026-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group will not receive any HPV education during the study period and will complete the same assessments as the intervention groups at all measurement time points.'}, {'type': 'EXPERIMENTAL', 'label': 'Video-Based Education Group', 'description': 'Participants in this group will receive HPV and HPV vaccination education delivered through a standardized educational video prepared in accordance with national health guidelines.', 'interventionNames': ['Behavioral: Video-Based HPV Education']}, {'type': 'EXPERIMENTAL', 'label': 'Face-to-Face Education Group', 'description': 'Participants in this group will receive HPV and HPV vaccination education through face-to-face training provided by the researcher using standardized educational materials.', 'interventionNames': ['Behavioral: Face-to-Face HPV Education']}], 'interventions': [{'name': 'Video-Based HPV Education', 'type': 'BEHAVIORAL', 'description': 'A structured educational video providing information about HPV infection, transmission, prevention, and HPV vaccination.', 'armGroupLabels': ['Video-Based Education Group']}, {'name': 'Face-to-Face HPV Education', 'type': 'BEHAVIORAL', 'description': 'A structured face-to-face educational session conducted by the researcher covering HPV infection, transmission, prevention, and HPV vaccination.', 'armGroupLabels': ['Face-to-Face Education Group']}, {'name': 'Video-Based HPV Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive HPV and HPV vaccination education through a standardized educational video including information about HPV transmission, related diseases, prevention methods, and the benefits of vaccination.', 'armGroupLabels': ['Video-Based Education Group']}, {'name': 'Face-to-Face HPV Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive HPV and HPV vaccination education through a structured face-to-face session conducted by the researcher using standardized educational materials.', 'armGroupLabels': ['Face-to-Face Education Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kahramanmaraş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emel GÜÇLÜ CİHAN Afşin Aile Sağlığı Merkezleri', 'role': 'CONTACT', 'email': 'emel_guclu4606@hotmail.com', 'phone': '03443004913'}], 'facility': 'Afşin Aile Sağlığı Merkezleri', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'centralContacts': [{'name': 'Emel Asst. Prof.', 'role': 'CONTACT', 'email': 'emel_guclu4606@hotmail.com', 'phone': '03443004913'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data will not be shared because the dataset contains sensitive personal information related to participants' health, vaccination intention, and demographic details. To protect participant confidentiality and privacy, access to the data is restricted to the research team."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emel GÜÇLÜ CİHAN', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emel GÜÇLÜ CİHAN', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}