Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-28 @ 7:36 PM
Study NCT ID:
NCT02106702
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Navigator Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'housing', 'timeFrame': '2 months, 6 months, 12 months', 'description': 'change from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention'}, {'measure': 'medical coverage', 'timeFrame': '2 months, 6 months,12 months', 'description': 'change from baseline in self-reported insurance coverage, measured by a survey tool at three time points after the initial detention, and use of community health services and jail health services, measured continuously via a community database for 12 months after the initial detention'}, {'measure': 'needle use', 'timeFrame': '2 months, 6 months, 12 months', 'description': 'change from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention'}], 'primaryOutcomes': [{'measure': 'substance use', 'timeFrame': '2 months, 6 months, 12 months', 'description': 'change from baseline in self-reported drug and alcohol use, measured by a survey tool, and actual use of five drugs (methamphetamine, cocaine, tetrahydrocannabinol, opiates, and benzodiazepines), measured by a urine screen, at three time points each'}, {'measure': 'recidivism', 'timeFrame': '12 months', 'description': 'number of times re-detained during the twelve-month study period, collected from jail records'}], 'secondaryOutcomes': [{'measure': 'sexual risk behavior', 'timeFrame': '2 months, 6 months, 12 months', 'description': 'change from baseline in self-reported sexual risk behaviors, measured by a survey tool at three time points after the initial detention'}, {'measure': 'adherence to HIV medications', 'timeFrame': '2 months, 6 months, 12 months', 'description': 'change from baseline in self-reported adherence (as a %) to antiretroviral therapy, measured by a survey tool at three time points after the initial detention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'detention', 'substance abuse'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San Francisco jail. Two thirds of those released with HIV-focused discharge planning are reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed with mental health conditions severe enough to require medication and a similar proportion report substance use disorders at the time of detention. While some community-based services exist, there remains a critical need to improve linkages to care and adherence to care plans for HIV-infected adults as they move between community and jail. The Navigator Project is a five-year randomized study that will test the effectiveness of an intensive enhanced case management intervention to reduce sex and drug-related HIV transmission risk; increase HIV medication adherence; reduce drug dependence; and reduce reincarceration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Detention in the San Francisco jail system\n* Confirmed HIV infection\n* Lifetime history of ever having met standardized criteria for drug or alcohol addiction\n* Likely release back into San Francisco without transfer to another facility\n* Agreement to work with Forensic AIDS Project to plan post-release care\n* Able and willing to provide informed consent\n* Not scheduled for release within 36 hours\n\nExclusion Criteria:\n\n* Undocumented HIV status\n* Inability to speak English or Spanish\n* Unable or unwilling to provide informed consent\n* Not under routine level of jail security'}, 'identificationModule': {'nctId': 'NCT02106702', 'acronym': 'NAV', 'briefTitle': 'The Navigator Project', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community', 'orgStudyIdInfo': {'id': 'R01DA027209', 'link': 'https://reporter.nih.gov/quickSearch/R01DA027209', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FAP counseling', 'description': 'Control arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release', 'interventionNames': ['Behavioral: Forensic AIDS Project']}, {'type': 'EXPERIMENTAL', 'label': 'Navigator enhanced case-management', 'description': 'Experimental arm: access to Navigator enhanced case-management services for one year after release', 'interventionNames': ['Behavioral: Navigator enhanced case-management']}], 'interventions': [{'name': 'Navigator enhanced case-management', 'type': 'BEHAVIORAL', 'description': "Patient navigators are non-clinical, paraprofessional peers who are HIV-infected and have lifetime histories of detention and substance abuse. Working with the patient, they facilitate adherence to a comprehensive care plan designed to address clients' multiple risks and needs. Patients have access to Navigator services for one year after study enrollment.", 'armGroupLabels': ['Navigator enhanced case-management']}, {'name': 'Forensic AIDS Project', 'type': 'BEHAVIORAL', 'description': 'The Forensics AIDS Project provides primary care to HIV-infected detainees, as well as up to 90 post-release case-management services which include discharge planning.', 'armGroupLabels': ['FAP counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Tenderloin Clinical Research Foundation', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Janet J Myers, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco Jail Health Services - HIV and Integrated Services', 'class': 'UNKNOWN'}, {'name': 'San Francisco Pretrial Diversion Project', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}