Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-26 @ 12:55 PM
Study NCT ID:
NCT00836550
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2009-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-based Counseling & Rapid HIV Testing for Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2009-02-03', 'studyFirstSubmitQcDate': '2009-02-03', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of HIV', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Consent to HIV testing', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'HIV knowledge measure', 'Teen HIV testing', 'HIV Seronegativity'], 'conditions': ['HIV', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study evaluated the educational effectiveness of a youth-friendly pre-test video (derived from a previous qualitative study) and compared it with in-person HIV pre-test counseling. A convenience sample of 200 medically stable individuals between the ages of 15 and 21 presenting to an urban ED were recruited to participate in this study and randomized into 2 groups. Individuals were eligible if they were English-speaking, sexually active and able to consent. All participants completed a sexual risk factor and demographic survey. Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but received pre-test HIV counseling from a trained public health advocate. HIV testing was optional'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15-21 year old\n* sexually active\n* English-Speaking\n\nExclusion Criteria:\n\n* medically unstable'}, 'identificationModule': {'nctId': 'NCT00836550', 'briefTitle': 'Video-based Counseling & Rapid HIV Testing for Teens', 'organization': {'class': 'OTHER', 'fullName': 'North Bronx Healthcare Network'}, 'officialTitle': 'An RCT to Evaluate the Effectiveness of an Emergency Department Based Multimedia HIV Testing Model in Adolescents', 'orgStudyIdInfo': {'id': '2005-456-001'}, 'secondaryIdInfos': [{'id': 'HD054315-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The participants spoke with a live counselor prior to answering the knowledge measure', 'interventionNames': ['Behavioral: in-person HIV pre-test counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Video', 'interventionNames': ['Behavioral: Video']}], 'interventions': [{'name': 'Video', 'type': 'BEHAVIORAL', 'description': 'The participants saw a 6 minute video', 'armGroupLabels': ['Video']}, {'name': 'in-person HIV pre-test counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Yvette Calderon, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacobi Medical Center/ Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Bronx Healthcare Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Yvette Calderon/ Principal Investigator', 'oldOrganization': 'Albert Einstein College of Medicine'}}}}