Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-06 @ 5:30 AM
Study NCT ID:
NCT02755402
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Pre-treatment Evaluation for HCV Infected Persons Who Inject Drugs
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who initiate treatment after first visit', 'timeFrame': '1 year', 'description': "Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls"}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who attend at least two visits in 6 months', 'timeFrame': '6 months', 'description': 'To compare linkage-to-care proportion at one year of treated PWID with untreated PWID at one year.'}, {'measure': 'Proportion of patients who initiate opioid substitution therapy during follow-up', 'timeFrame': '6 months', 'description': 'To compare opioid substitution therapy initiation rates at one year of treated and untreated PWID.'}, {'measure': 'Difference in number of injection between the month prior to study entry and the last month of follow-up', 'timeFrame': '6 months', 'description': 'To compare drug use reduction during the study period of treated PWID with untreated PWID at one year.'}, {'measure': 'Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment', 'timeFrame': '12 weeks post-treatment', 'description': 'To compare proportion of treated patients who achieved SVR12 with historical controls treated in phase III trials.'}, {'measure': 'Proportion of patients with a re-infection within six months of end-of-treatment', 'timeFrame': '6 months post-treatment', 'description': 'To evaluate rapid re-infection rates (\\<6 months) of patients who achieve end-of-treatment undetectability.'}, {'measure': 'Difference in HCV viral load results between techniques', 'timeFrame': 'At enrollment', 'description': 'To compare Xpert HCV Viral Load® (Cepheid) viral loads results to HCV RealTime® (Abbott) results.'}, {'measure': 'Recontact of initially untreatable patients', 'timeFrame': '1 year', 'description': 'To determine the proportion of patients who change from untreatable to treatable that can be successfully recontacted and linked to care among patients initially classified as untreatable'}, {'measure': 'Treatment of initially untreatable patients', 'timeFrame': '1 year', 'description': 'To determine the proportion of patients who will initiate HCV treatment among those who were initially classified as untreable.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C', 'Intravenous Drug Users']}, 'referencesModule': {'references': [{'pmid': '35990750', 'type': 'DERIVED', 'citation': 'Martel-Laferriere V, Brissette S, Wartelle-Bladou C, Juteau LC, Popa M, Goyer ME, Bruneau J. Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs. Subst Abuse. 2022 Aug 12;16:11782218221119068. doi: 10.1177/11782218221119068. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population.\n\nThe hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly.\n\nBy using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit.\n\nThe aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.', 'detailedDescription': "This is a non-randomized, open-label study that aims to include HCV-infected patients who inject drugs and who do not know their treatment eligibility status. A total of 200 patients will be evaluated using our rapid evaluation protocol, which will include basic blood tests, viral load measurement using Cepheid's Xpert® HCV Viral Load technique (which will be controlled at the same time by COBAS® AmpliPrep/ COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche), available at the CHUM and approved by Health Canada), a liver fibrosis assessment and HCV genotyping. The results of the basic tests, viral load tests and FibroScan® test will be available on the same day as the patient's visit and will allow the investigator to determine straightaway whether or not the patient is treatable based on the RAMQ's reimbursement criteria at the time of the study.\n\nIf the patient is treatable, once the genotype result has been obtained, the most appropriate treatment for their medical condition, degree of liver fibrosis and genotype will be prescribed. There will be no other visits between the initial visit and the treatment initiation visit. The patient will be given an appointment for the treatment initiation visit once the medication has been approved by the RAMQ or the patient's private insurer. The patient will be seen again at weeks 2 and 4 of treatment, at the end of treatment (usually week 12), then 12, 24 and 36 weeks post-treatment.\n\nIf the patient is not treatable, he/she will be referred to the CHUM Addiction Medicine Clinic or the UHRESS (if HIV-coinfected status) for management, which will include longitudinal follow-up of his HCV and substance abuse. The patient will be seen again at 6 months and 1 year to determine whether or not there has been linkage-to-care, initiation of opioid substitution therapy if indicated and if the patient has reduced his injection drug use.\n\nIf an untreatable patient becomes treatable during follow-up, treatment will be offered.\n\nAt the same time, we will review the records of patients seen at the CHUM Addiction Medicine Clinic between October 2014 and June 2016 who meet the inclusion criteria for the study cohort and the RAMQ's treatment eligibility criteria. This cohort will be used as an historical cohort to determine the rate of linkage to treatment with the standard pre-treatment evaluation protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who inject drugs, defined as having injected in the past year\n* Able to give an informed consent\n* Unknown treatment eligibility status\n\nExclusion Criteria:\n\n* Patients actively engaged in HCV follow up\n* Patients visibly intoxicated at initial study visit\n* Pregnant or breastfeeding women\n* Pacemaker.'}, 'identificationModule': {'nctId': 'NCT02755402', 'briefTitle': 'Accelerated Pre-treatment Evaluation for HCV Infected Persons Who Inject Drugs', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Impact of an Accelerated Pre-treatment Evaluation on Linkage-to-care and Linkage-to-treatment for HCV Infected Persons Who Inject Drugs', 'orgStudyIdInfo': {'id': 'IN-CA-337-2100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid evaluation', 'description': 'Transient elastography, Xpert HCV Viral load, medical and nurse visits', 'interventionNames': ['Device: Xpert HCV Viral load', 'Device: Transient elastography']}], 'interventions': [{'name': 'Xpert HCV Viral load', 'type': 'DEVICE', 'description': 'HCV viral load testing', 'armGroupLabels': ['Rapid evaluation']}, {'name': 'Transient elastography', 'type': 'DEVICE', 'description': 'Evaluation of liver fibrosis', 'armGroupLabels': ['Rapid evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Valérie Martel-Laferrière, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRCHUM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Cepheid', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical microbiologist', 'investigatorFullName': 'Valérie Martel-Laferrière', 'investigatorAffiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}}}}