Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT00273403
Status:
UNKNOWN
Last Update Posted:
2006-09-22
First Post:
2006-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
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': 'D008283', 'term': 'Maintenance'}, {'id': 'D006297', 'term': 'Health Services Accessibility'}], 'ancestors': [{'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 5100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2006-09-21', 'studyFirstSubmitDate': '2006-01-04', 'studyFirstSubmitQcDate': '2006-01-04', 'lastUpdatePostDateStruct': {'date': '2006-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.'}], 'secondaryOutcomes': [{'measure': 'Housing stability: at 3, 6, and 12 months'}, {'measure': 'Substance use: at 3, 6, and 12 months'}, {'measure': 'Whether receiving HIV primary care: at 3, 6, and 12 months'}, {'measure': 'Whether on HIV meds: at 3, 6, and 12 months'}]}, 'conditionsModule': {'keywords': ['HIV', 'Minority Groups', 'Health Services Accessibility', 'Quality of Life'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This outcome evaluation effort provides the opportunity to learn what programmatic approaches effectively address two of the most difficult hurdles in HIV health services delivery: (1) getting people who would benefit from health care to use it and (2) getting people who do use health care to do so more consistently and effectively. The New York HIV Planning Council (through MHRA) has funded 23 agencies to achieve these objectives for people of color with HIV disease.', 'detailedDescription': 'All clients are assessed upon entry into the program, have their service utilization tracked, and then are reassessed at three, six, and twelve months following program entry.\n\nThe main client-level data elements collected during baseline and follow-up interviews are the following:\n\n* Biological markers (including HIV status, viral load, t-cell count)\n* Demographic characteristics\n* Adherence to treatment\n* Barriers to care\n* Social support\n* Substance use and treatment\n* Functional health status\n\nFunctional Health Status is used in this evaluation as the primary measure of final client "outcomes." The Functional Health Status items we use are from the ACTG SF-21 (a modified version of the Medical Outcomes Study instrument).\n\nThe overall evaluation objectives are to:\n\n* Describe the change in functional health status for different populations and groups of clients.\n* Identify services or constellations of services and intensity of services associated with change in functional health status.\n* Assess whether programs meet intermediate objectives (decreased drug use, increased service use, improved housing stability).\n* Identify barriers to access to and maintenance in care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive\n* Not in HIV care, or difficulty being maintained in HIV care\n* HIV-negative but at high risk of HIV infection\n\nExclusion Criteria:\n\n* HIV-negative and not at high risk of HIV infection'}, 'identificationModule': {'nctId': 'NCT00273403', 'briefTitle': 'Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA', 'organization': {'class': 'OTHER', 'fullName': 'The New York Academy of Medicine'}, 'officialTitle': 'Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA', 'orgStudyIdInfo': {'id': '112299'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Maintenance in Care Services', 'type': 'BEHAVIORAL'}, {'name': 'Access to Care Services', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11205', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HHC Cumberland Diagnostic and Treatment Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11213', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Interfaith Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10550', 'city': 'Mount Vernon', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Vernon Hospital', 'geoPoint': {'lat': 40.9126, 'lon': -73.83708}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Partnership Homeless Services Corp.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10002', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Betances Health Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Saint Vincents Hospital and Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bellevue Hospital Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'William F. Ryan Community Health Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'African Services Committee', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Bridge, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Settlement Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10035', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New York Harm Reducation Educators, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Harlem Hospital Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Planned Parenthood of New York City, Project Street Beat', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10452', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urban Horizons, The Institute for Urban Family Health', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10454', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Health People', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bronx Lebanon Hospital Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Health Center at Tremont, North Bronx Healthcare Network', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10701', 'city': 'Yonkers', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Greyston Health Services, Inc.', 'geoPoint': {'lat': 40.9304, 'lon': -73.89789}}, {'zip': '10703', 'city': 'Yonkers', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Saint Johns Riverside Hospital, Park Care Pavilion (ATC program)', 'geoPoint': {'lat': 40.9304, 'lon': -73.89789}}, {'zip': '10703', 'city': 'Yonkers', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Saint Johns Riverside Hospital, Park Care Pavilion (MIC Program)', 'geoPoint': {'lat': 40.9304, 'lon': -73.89789}}], 'centralContacts': [{'name': 'Elana Behar, MA', 'role': 'CONTACT', 'email': 'ebehar@nyam.org', 'phone': '212-822-7374'}, {'name': 'John Chin, PhD', 'role': 'CONTACT', 'email': 'jchin@nyam.org', 'phone': '212-419-3537'}], 'overallOfficials': [{'name': 'John Chin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Academy of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Academy of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Solutions', 'class': 'OTHER'}]}}}