Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT01402466
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urban Health Study II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076064', 'term': 'Drug Misuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log10 viral load', 'timeFrame': 'Every 3 months for 2 years', 'description': 'Changes in viral load over time will be compared between the standard referral and Project Bridge Groups'}], 'secondaryOutcomes': [{'measure': 'Engagement in HIV Care', 'timeFrame': 'Every 3 months for 2 years', 'description': 'The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups'}, {'measure': 'Initiation of Highly Active Antiretroviral Therapy (HAART)', 'timeFrame': 'Every 3 months for 2 years', 'description': 'The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug users', 'criminal justice', 'HIV care', 'HAART', 'incarceration'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.', 'detailedDescription': 'The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.\n\nHIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.\n\nThe study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* HIV antibody positive\n* not currently receiving HIV care\n\nExclusion Criteria:\n\n* already in care\n* unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01402466', 'briefTitle': 'Urban Health Study II', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'Finding, Testing and Treating High-Risk Probationers and Parolees With HIV', 'orgStudyIdInfo': {'id': '12690'}, 'secondaryIdInfos': [{'id': 'R01MH094090', 'link': 'https://reporter.nih.gov/quickSearch/R01MH094090', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Referral', 'description': 'Participants randomized to this arm will be referred to local HIV care resources', 'interventionNames': ['Behavioral: Standard Referral']}, {'type': 'EXPERIMENTAL', 'label': 'Project Bridge', 'description': 'Participants randomized to this arm will be given the Project Bridge intervention', 'interventionNames': ['Behavioral: Project Bridge']}], 'interventions': [{'name': 'Standard Referral', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to this arm will be referred to local HIV care resources', 'armGroupLabels': ['Standard Referral']}, {'name': 'Project Bridge', 'type': 'BEHAVIORAL', 'description': 'Arm 2', 'armGroupLabels': ['Project Bridge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94104', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'RTI International Urban Health Program', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Alex H Kral, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}