Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 4:18 AM
Study NCT ID:
NCT01184157
Status:
COMPLETED
Last Update Posted:
2010-08-18
First Post:
2010-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D006069', 'term': 'Gonorrhea'}], 'ancestors': [{'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-17', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of tests received'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chlamydia', 'Gonorrhea']}, 'referencesModule': {'references': [{'pmid': '21099596', 'type': 'DERIVED', 'citation': 'Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.'}]}, 'descriptionModule': {'briefSummary': 'This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in Contraceptive CHOICE cohort study\n* Using a long-acting reversible method of contraception\n* Completed baseline clinical survey in the Contraceptive CHOICE cohort study\n\nExclusion Criteria:\n\n* Living outside the United States at time of annual STI screening'}, 'identificationModule': {'nctId': 'NCT01184157', 'briefTitle': 'Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users', 'orgStudyIdInfo': {'id': '07-0256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home', 'description': 'Home-based STI screening using self-obtained vaginal swabs and postal return of samples.', 'interventionNames': ['Behavioral: Home screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic', 'description': 'Receive STI screening in a clinical setting such as a private physician or clinic.', 'interventionNames': ['Behavioral: Clinic screening']}], 'interventions': [{'name': 'Home screening', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Home']}, {'name': 'Clinic screening', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jeffrey Peipert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jeffrey Peipert, MD PhD', 'oldOrganization': 'Washington University School of Medicine'}}}}