Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Secondary objectives of the research are:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Other | All participants recruited during the RDS survey. |
|
| HCV infected patients | Other | HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL) |
|
| Patients with hepatitis C | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCV screening | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated and cured DU participants. | Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion. | SVR12 (12 weeks after end of HCV treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a HCV positive serology | Proportion of participants with a HCV positive serology among all participants | Screening RDS |
| Estimated number of drug users in the city of Montpellier |
Not provided
Inclusion Criteria:
Age> 18 years
Be an active drug user defined by:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HELENE DONNADIEU-RIGOLE, MD, PhD | CHU Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Montpellier | 34394 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27168667 | Background | 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. | |
| 26806260 | Background | 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. |
| Label | URL |
|---|---|
| Combating Hepatitis B and C to reach elimination by 2030. WHO, 2016 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Diagnosis of hepatitis C | Diagnostic Test | 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. |
|
| HCV treatment | Drug | Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment. |
|
Estimated number of drug users in the city of Montpellier by capture/recapture survey
| Screening RDS |
| Proportion of participants with detectable HCV-RNA | Proportion of patients with HCV RNA > 10 IU/mL among those with positive HCV serology | Screening RDS |
| Proportion of participants initiating anti-viral treatment | Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA >10 UI/mL | Day 0 |
| Rate of reinfection | 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 | Week 48 |
| Hepatitis B infection rate | Proportion of participants with HBs antigene and positive B-DNA at baseline | Screening RDS |
| HIV infection rate and ART coverage | Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline | Screening RDS |
| 22310560 | Background | 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. |
| 29432973 | Background | 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. |
| 27178119 | Background | 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. |
| 27537841 | Background | 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. |
| 28004616 | Background | 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. |
| 35774932 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |