Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04008927
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Community-based Intervention Among Active Drug Users in Montpellier
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Effectiveness-implementation hybrid study type 2. This study design will simultaneously allow assessing the effectiveness of the model, using the percentage of HCV cure as criteria, and the feasibility by measuring potential obstacles during implementation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 554}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of treated and cured DU participants.', 'timeFrame': 'SVR12 (12 weeks after end of HCV treatment)', 'description': 'Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with a HCV positive serology', 'timeFrame': 'Screening RDS', 'description': 'Proportion of participants with a HCV positive serology among all participants'}, {'measure': 'Estimated number of drug users in the city of Montpellier', 'timeFrame': 'Screening RDS', 'description': 'Estimated number of drug users in the city of Montpellier by capture/recapture survey'}, {'measure': 'Proportion of participants with detectable HCV-RNA', 'timeFrame': 'Screening RDS', 'description': 'Proportion of patients with HCV RNA \\> 10 IU/mL among those with positive HCV serology'}, {'measure': 'Proportion of participants initiating anti-viral treatment', 'timeFrame': 'Day 0', 'description': 'Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA \\>10 UI/mL'}, {'measure': 'Rate of reinfection', 'timeFrame': 'Week 48', 'description': 'Proportion of cured participants re-infected within months after end of treatment defined by positive HCV-RNA of different genotype at SVR12 or by positive HCV-RNA at W44/48'}, {'measure': 'Hepatitis B infection rate', 'timeFrame': 'Screening RDS', 'description': 'Proportion of participants with HBs antigene and positive B-DNA at baseline'}, {'measure': 'HIV infection rate and ART coverage', 'timeFrame': 'Screening RDS', 'description': 'Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'RDS survey', 'Communauty-based intervention', 'Viral hepatitis C'], 'conditions': ['Drug Use', 'HCV Infection']}, 'referencesModule': {'references': [{'pmid': '27168667', 'type': 'BACKGROUND', 'citation': 'Blackburn NA, Patel RC, Zibbell JE. Improving Screening Methods for Hepatitis C Among People Who Inject Drugs: Findings from the HepTLC Initiative, 2012-2014. Public Health Rep. 2016 May-Jun;131 Suppl 2(Suppl 2):91-7. doi: 10.1177/00333549161310S214.'}, {'pmid': '26806260', 'type': 'BACKGROUND', 'citation': 'Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, Hezode C, Pawlotsky JM. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect. 2016 May;22(5):459.e1-6. doi: 10.1016/j.cmi.2016.01.009. Epub 2016 Jan 22.'}, {'pmid': '22310560', 'type': 'BACKGROUND', 'citation': 'Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.'}, {'pmid': '29432973', 'type': 'BACKGROUND', 'citation': 'Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.'}, {'pmid': '27178119', 'type': 'BACKGROUND', 'citation': 'Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.'}, {'pmid': '27537841', 'type': 'BACKGROUND', 'citation': 'Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9.'}, {'pmid': '28004616', 'type': 'BACKGROUND', 'citation': 'Leon L, Kasereka S, Barin F, Larsen C, Weill-Barillet L, Pascal X, Chevaliez S, Pillonel J, Jauffret-Roustide M, LE Strat Y. Age- and time-dependent prevalence and incidence of hepatitis C virus infection in drug users in France, 2004-2011: model-based estimation from two national cross-sectional serosurveys. Epidemiol Infect. 2017 Apr;145(5):895-907. doi: 10.1017/S0950268816002934. Epub 2016 Dec 22.'}, {'pmid': '35774932', 'type': 'DERIVED', 'citation': "Nagot N, D'Ottavi M, Quillet C, Debellefontaine A, Castellani J, Langendorfer N, Hanslik B, Guichard S, Baglioni R, Faucherre V, Tuaillon E, Pageaux GP, Laureillard D, Donnadieu-Rigole H. Reaching Hard-to-Reach People Who Use Drugs: A Community-Based Strategy for the Elimination of Hepatitis C. Open Forum Infect Dis. 2022 Apr 14;9(6):ofac181. doi: 10.1093/ofid/ofac181. eCollection 2022 Jun."}], 'seeAlsoLinks': [{'url': 'http://apps.who.int/iris/bitstream/10665/206453/1/WHO_HIV_2016.04_eng.pdf', 'label': 'Combating Hepatitis B and C to reach elimination by 2030. WHO, 2016'}]}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.', 'detailedDescription': 'Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey\n\nSecondary objectives of the research are:\n\n* To estimate the seroprevalence of hepatitis C in active DUs in Montpellier;\n* To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method;\n* To estimate HCV care cascade steps in active DUs in Montpellier;\n* To identify the factors associated with HCV treatment failure;\n* To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment;\n* To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years\n* Be an active drug user defined by:\n\n 1. Report current and regular (Last uptake no more than 3 days ago and at least 10 times a month) use of illicit psychoactive substances other than cannabis (heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or misused medications (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine) AND\n 2. Positive urine test for a psychoactive substance other than cannabis (Heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or a misused medication (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine).\n\nExclusion Criteria:\n\n* Inability to understand the study\n* Be under guardianship, curatorship or future protection mandate\n* Lack of informed consent'}, 'identificationModule': {'nctId': 'NCT04008927', 'acronym': 'ICONE', 'briefTitle': 'A Community-based Intervention Among Active Drug Users in Montpellier', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.', 'orgStudyIdInfo': {'id': 'ANRS 95050 ICONE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All patients', 'description': 'All participants recruited during the RDS survey.', 'interventionNames': ['Diagnostic Test: HCV screening']}, {'type': 'OTHER', 'label': 'HCV infected patients', 'description': 'HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA\\>10 UI/mL)', 'interventionNames': ['Diagnostic Test: Diagnosis of hepatitis C']}, {'type': 'OTHER', 'label': 'Patients with hepatitis C', 'description': 'Patients diagnosed with chronic hepatitis C will be prescribed with DAA treatment on research site. After one month they will be referred to conventional health structure for treatment follow-up.', 'interventionNames': ['Drug: HCV treatment']}], 'interventions': [{'name': 'HCV screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services.', 'armGroupLabels': ['All patients']}, {'name': 'Diagnosis of hepatitis C', 'type': 'DIAGNOSTIC_TEST', 'description': 'HCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA\\>10 UI/mL). In addition a measure of the liver stiffness will be performed.', 'armGroupLabels': ['HCV infected patients']}, {'name': 'HCV treatment', 'type': 'DRUG', 'description': 'Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.', 'armGroupLabels': ['Patients with hepatitis C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34394', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'HELENE DONNADIEU-RIGOLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Montpellier, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}