Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-13 @ 7:27 PM
Study NCT ID:
NCT03195205
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification to Elimination in HCV-Infected Individuals
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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3051}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positivity rates', 'timeFrame': '20 - 40 minutes', 'description': 'The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.'}], 'secondaryOutcomes': [{'measure': 'Linked to care', 'timeFrame': '1 - 3 months', 'description': 'The study will measure the percentage of patients identified as reactive that follow up by linking to care.'}, {'measure': 'Treatment', 'timeFrame': '8 - 24 weeks', 'description': 'The study will measure the percentage of patients linked to care who complete treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': "Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this estimate, there are over 43,000 individuals affected with chronic HCV living in rural Pennsylvania. Rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs.\n\nRQ1: Will the community based delivery system for Hepatitis C screenings see an increase in positivity rates?\n\nHO1: There is no relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.\n\nHA1: There is a relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.", 'detailedDescription': "In rural Pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. Using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations.\n\nIt is estimated that 35% to 65% of Opioid Substitution Treatment Patients (OST), are infected with HCV. Therefore, OPT programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. In addition, high volume venues attracting high-risk populations will also be targeted to encourage HCV screening, education, and treatment.\n\nPrimary Objectives:\n\nTo screen Opioid Substitution Treatment Patients (OST), high-risk individual at Opioid Treatment Programs (OTP), and/or all high-risk populations in outlying sites (Anti-HCV prevalence)\n\nTo initiate HCV treatment of OST patients and other high-risk individuals at OTP facilities and/or high risk populations in outlying sites (linkage of care)\n\nTo maintain the successful HCV therapy and cure \\[Sustained Viral Response (SVR)\\] in OST patients and other high-risk individuals at OPT facility and/or high risk populations in outlying sites (retention)\n\nTo facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects will be included in the study if the following criteria is met:\n\n1. The subject must be an Opioid Substitution Treatment patient.\n2. The subject must fall into another high-risk population for the HCV.\n\nExclusion Criteria:\n\nSubjects may be excluded from the study if the subject falls into an exclusion category as identified as:\n\n1. The subject cannot be or suspected of being pregnant\n2. The subject cannot be under the age of 18 years.\n3. No subjects requiring a legally authorized representative will be enrolled'}, 'identificationModule': {'nctId': 'NCT03195205', 'briefTitle': 'Identification to Elimination in HCV-Infected Individuals', 'organization': {'class': 'OTHER', 'fullName': 'TruCare Internal Medicine & Infectious Disease'}, 'officialTitle': 'A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations', 'orgStudyIdInfo': {'id': 'GSI-2016-09-APR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High-Risk Patients', 'description': 'OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations', 'interventionNames': ['Diagnostic Test: OraQuick HCV Rapid Antibody Test']}], 'interventions': [{'name': 'OraQuick HCV Rapid Antibody Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'HCV Screening', 'armGroupLabels': ['High-Risk Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15801', 'city': 'DuBois', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'TruCare Internal Medicine & Infectious Diseases', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}], 'overallOfficials': [{'name': 'Tuesdae R Stainbrook, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trucare Internals Medicine & Infectious Disease'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TruCare Internal Medicine & Infectious Disease', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tuesdae Stainbrook, DO, MPH', 'investigatorAffiliation': 'TruCare Internal Medicine & Infectious Disease'}}}}