Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT00780260
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2008-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Case Management Alternatives for African American Women at High Risk for HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 562}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2008-10-24', 'studyFirstSubmitQcDate': '2008-10-24', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance abuse treatment linkage at 3 months', 'timeFrame': '3 months'}, {'measure': 'Substance abuse treatment engagement at 6 months', 'timeFrame': '6 months'}, {'measure': 'HIV related care at 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'Other health service utilization at 3 and 6 months', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'African Americans', 'Women', 'Case Management'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test two innovative case management approaches designed to increase linkages and engagement with drug abuse treatment, HIV-related care, and other health services among an underserved population of African American women at risk for HIV.', 'detailedDescription': 'The study is fundamentally concerned with the implementation and evaluation of theoretically-based, culturally appropriate case management interventions targeting individual, social and environmental factors among highly vulnerable African American women. The research is designed to test innovative, comprehensive approaches to HIV prevention/intervention through case management driven service linkage and engagement. Testing new approaches to intervention with African-American women at high risk for HIV addresses a particularly urgent public health need in Miami, as well as other large metropolitan areas, where officials continue to document epidemic rates of HIV/AIDS clustered in urban, impoverished African-American communities.\n\nComparison: Participants will be randomly assigned to: a Strengths-Based / Professional Only Condition in which clients participate in a "strengths-based" case management approach; or, a Strengths-Based / Professional/Peer Condition in which a team composed of: a) a credentialed, professional case manager and b) a recovering addict peer - both trained in "strengths-based" case management techniques - develop and facilitate the implementation of a service plan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current substance abuse\n* Current high-risk sexual behavior\n* African American racial identification\n\nExclusion Criteria:\n\n* Non resident of Miami-Dade county'}, 'identificationModule': {'nctId': 'NCT00780260', 'briefTitle': 'Case Management Alternatives for African American Women at High Risk for HIV', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Case Management Alternatives for African American Women at High Risk for HIV', 'orgStudyIdInfo': {'id': '2R01DA013131-06A2', 'link': 'https://reporter.nih.gov/quickSearch/2R01DA013131-06A2', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA013131-06A2', 'link': 'https://reporter.nih.gov/quickSearch/R01DA013131-06A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '5 session strengths-based case management intervention delivered by a professional case manager and a peer support specialist team', 'interventionNames': ['Behavioral: strengths-based case management']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '5 session strengths-based case management intervention delivered by a professional case manager.', 'interventionNames': ['Behavioral: strengths-based case management']}], 'interventions': [{'name': 'strengths-based case management', 'type': 'BEHAVIORAL', 'description': '5 session individual strengths-based case management; peer-involvement v. no peer involvement', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Hilary L Surratt, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Southeastern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}