Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-05 @ 6:44 PM
Study NCT ID:
NCT04036760
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination.', 'timeFrame': '2 Years'}], 'secondaryOutcomes': [{'measure': 'The proportion of those adult inmates who were successfully linked to care at Bellevue Hospital Center (BHC) during the period before and after the implementation of care coordination who subsequently had at least two visits with an HCV provider.', 'timeFrame': '2 Years'}, {'measure': 'The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then initiated Hepatitis C Virus (HCV) treatment.', 'timeFrame': '2 Years'}, {'measure': 'The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then went onto achieve an Sustained Virologic Response (SVR) when treated.', 'timeFrame': '2 Years'}, {'measure': 'The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who were linked to ancillary services.', 'timeFrame': '2 Years'}, {'measure': 'Retention in care as defined as two sequential clinic ID clinic visits during 12 months', 'timeFrame': '2 Years', 'description': 'Number of patients who are able to retain 2 sequential visits during 12 months'}, {'measure': 'Documented sustained virologic response (SVR)', 'timeFrame': '2 Years', 'description': 'no detectable RNA in 2 years post treatment'}, {'measure': 'Documented sustained HCV cure', 'timeFrame': '2 Years', 'description': 'Showing no symptoms of HCV for 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '31395019', 'type': 'DERIVED', 'citation': 'Akiyama MJ, Columbus D, MacDonald R, Jordan AO, Schwartz J, Litwin AH, Eckhardt B, Carmody E. Linkage to hepatitis C care after incarceration in jail: a prospective, single arm clinical trial. BMC Infect Dis. 2019 Aug 8;19(1):703. doi: 10.1186/s12879-019-4344-1.'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails. Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December 31, 2016 will be offered participation in a transitional care coordination program. The rates of linkage of these individuals following release from jail will be compared to a historical cohort of adult patients with chronic Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31, 2015.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.", 'genderDescription': "Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.\n\nExclusion Criteria:\n\n* Individuals who refuse to participate in the study when approached\n* Individuals who are unable or unwilling to sign a consent form agreeing to participate. Participants must have sufficient literacy to sign their name, as written informed consent is required for study participation\n* Individuals who are unable to successfully negotiate the use of a telephone interpreter if required\n* Individuals who have received a sentence that extends beyond the interval of follow up (one year sentence in city jail)\n* Individuals who will be moved upstate to prison directly from jail\n* Individuals who die prior to discharge from Rikers Island"}, 'identificationModule': {'nctId': 'NCT04036760', 'briefTitle': 'Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails', 'orgStudyIdInfo': {'id': '14-02105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care transitional care coordination'}, {'label': 'Research transitional care coordination', 'interventionNames': ['Behavioral: Research transitional care coordination']}], 'interventions': [{'name': 'Research transitional care coordination', 'type': 'BEHAVIORAL', 'description': 'Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.', 'armGroupLabels': ['Research transitional care coordination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Benjamin Eckhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}