Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 4:40 AM
Study NCT ID:
NCT03337269
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV vaccine acceptability', 'timeFrame': 'Up to 6 months', 'description': 'Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement "I would be willing to accept the HPV vaccine today."'}], 'secondaryOutcomes': [{'measure': 'HPV vaccine knowledge', 'timeFrame': 'Up to 6 months', 'description': 'Subject knowledge of the HPV vaccine and its associated risks and benefits, as assessed through a survey. Subjects are asked to answer 7 questions and total knowledge score is calculated by an unweighted sum of correct answers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV-Related Cervical Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31306313', 'type': 'DERIVED', 'citation': 'Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females ages greater than or equal to 12 years and less than or equal to 26 years\n2. Presenting to a gynecology clinic for a routine or problem visit\n3. Ability to read and write\n\nExclusion Criteria:\n\n1. Women ages less than or greater than 12 years or greater than 26 years\n2. Women with known cervical cancer\n3. Known pregnancy\n4. Prior initiation or completion of the HPV vaccine series'}, 'identificationModule': {'nctId': 'NCT03337269', 'briefTitle': 'Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake', 'orgStudyIdInfo': {'id': '826486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Subject does not receive an educational intervention', 'interventionNames': ['Other: Control']}, {'type': 'OTHER', 'label': 'Educational video', 'description': 'Subject watches an educational video', 'interventionNames': ['Other: Educational video']}, {'type': 'OTHER', 'label': 'Educational handout', 'description': 'Subject reads an educational handout', 'interventionNames': ['Other: Educational handout']}], 'interventions': [{'name': 'Educational video', 'type': 'OTHER', 'description': 'Approximately 7 minute video on the HPV vaccine', 'armGroupLabels': ['Educational video']}, {'name': 'Educational handout', 'type': 'OTHER', 'description': 'One page handout on the HPV vaccine', 'armGroupLabels': ['Educational handout']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Control', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}