Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT04578093
Status:
WITHDRAWN
Last Update Posted:
2023-03-07
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'case-control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI No Longer at Institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inquiries made of provider', 'timeFrame': '6 months', 'description': 'Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider.'}], 'secondaryOutcomes': [{'measure': 'LARC uptake', 'timeFrame': '3 years', 'description': 'Incidence of teenager using IUD or subnormal implant.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teen pregnancy, adolescent contraception'], 'conditions': ['Contraception Behavior']}, 'descriptionModule': {'briefSummary': 'Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'genderBased': True, 'genderDescription': 'only females can receive LARC', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfemale, never used LARC, attending high school, less than 20 yo\n\nExclusion Criteria:\n\nused LARC'}, 'identificationModule': {'nctId': 'NCT04578093', 'briefTitle': 'Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy', 'orgStudyIdInfo': {'id': 'IRB 20-0250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Will receive adjusts curriculum', 'interventionNames': ['Behavioral: LARC peer-based curriculum']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Will receive unadjusted curriculum'}], 'interventions': [{'name': 'LARC peer-based curriculum', 'type': 'BEHAVIORAL', 'description': 'Peer-based educational videos and supplemental activities', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pooja R Patel, MD, MPH, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}