Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT06483451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitated Telemedicine in the Catholic Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCV Treatment Initiation', 'timeFrame': '1 year', 'description': 'The time point that HCV treatment is initiated'}, {'measure': 'HCV Sustained Virologic Response', 'timeFrame': '1 year', 'description': 'The time point that HCV cure (sustained virologic response) is achieved'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telemedicine'], 'conditions': ['HCV']}, 'referencesModule': {'references': [{'pmid': '38568601', 'type': 'BACKGROUND', 'citation': 'Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA. 2024 Apr 23;331(16):1369-1378. doi: 10.1001/jama.2024.2452.'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.', 'detailedDescription': 'Hepatitis C virus (HCV) is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. In 2013, direct-acting antivirals were introduced for HCV treatment: all oral medications with minimal side effects and excellent efficacy when taken for 2-3 months. However, only 34% of eligible individuals received direct-acting antivirals between 2013 and 2022. Moreover, HCV treatment with direct-acting antivirals was substantially lower among people with opioid use disorder. Access to highly effective HCV treatment by the populations with the greatest need remains inadequate.\n\nTo address this issue, we propose that facilitated telemedicine could be a bridge to integrate HCV treatment into opioid treatment programs. In our model, telemedicine encounters are facilitated by a case manager who is also a patient advocate and an educator. We recently completed a randomized clinical trial that compared facilitated telemedicine integrated into opioid treatment programs for HCV treatment compared to offsite referral. The HCV cure rate was 90.3% in facilitated telemedicine compared to 39.4% in offsite referral.\n\nIn the proposed project, we seek to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals enrolled in the opioid treatment programs of Catholic Health System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* evidence of active HCV infection\n\nExclusion Criteria:\n\n* no evidence of active HCV infection'}, 'identificationModule': {'nctId': 'NCT06483451', 'briefTitle': 'Facilitated Telemedicine in the Catholic Health System', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Hepatitis C Virus Management Through Facilitated Telemedicine Integrated Into Opioid Treatment Programs: Catholic Health System Experience', 'orgStudyIdInfo': {'id': 'STUDY00008372'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with active HCV infection', 'description': 'Individuals with active HCV infection'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew H Talal, MD, MPH', 'role': 'CONTACT', 'email': 'ahtalal@buffalo.edu', 'phone': '7168293101'}], 'overallOfficials': [{'name': 'Andrew H Talal, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be de-identified. Available upon reasonable request after publication of study results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Andrew Talal', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}