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| Name | Class |
|---|---|
| Cepheid | INDUSTRY |
| Réseau Hépatite C Bruxelles | UNKNOWN |
| Gilead Sciences | INDUSTRY |
| AbbVie |
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The main objective of this study is to assess the interest (linkage to care) of the Cepheid GeneXpert HCV VL Fingerstick test in Brussels among drug users or former users in contact with the Réseau Hépatite C Bruxelles organization through different partners of this network.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Ex) Drug users recognized at-risk population of infection with Hepatitis C virus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GeneXpert HCV VL Fingerstick test | Diagnostic Test | The participants will have a molecular test (GeneXpert HCV VL Fingerstick, Cepheid) that quantifies hepatitis C virus (HCV) RNA levels directly from a fingerstick blood sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches | 1 year after the start of recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick | The participants will answer to a qualitative questionnaire about the Cepheid device and will give their preference between the Cepheid GeneXpert HCV VL test to routine venous tests | on day of enrollment |
| Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will be taken in charge by hepatologist |
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Inclusion Criteria:
Exclusion Criteria:
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All marginalized (ex) drug users with a positive serology (for HCV) without a confirmed diagnosis of chronic hepatitis C, who are in contact with the Réseau Hépatite C Bruxelles organization and other front-line partners in Brussels
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Mulkay, MD | Centre Hospitalier Universitaire Saint Pierre | Principal Investigator |
| Lise Meunier, MD | ASBL Réseau Hépatite C Bruxelles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683982 | Background | Grebely J, Bruneau J, Lazarus JV, Dalgard O, Bruggmann P, Treloar C, Hickman M, Hellard M, Roberts T, Crooks L, Midgard H, Larney S, Degenhardt L, Alho H, Byrne J, Dillon JF, Feld JJ, Foster G, Goldberg D, Lloyd AR, Reimer J, Robaeys G, Torrens M, Wright N, Maremmani I, Norton BL, Litwin AH, Dore GJ; International Network on Hepatitis in Substance Users. Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs. Int J Drug Policy. 2017 Sep;47:51-60. doi: 10.1016/j.drugpo.2017.05.019. Epub 2017 Jul 3. | |
| 30157316 |
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Not provided
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D000076064 | Drug Misuse |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| one year after enrollment |
| Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will initiate a anti-viral treatment | one year after enrollment |
| Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who have a Sustained Virological Response (SVR) at 12 weeks after the end of treatment | one year after enrollment |
| Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment | up one year after enrollment |
| Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and a recovery defined by a Sustained Virological Response (SVR) | up one year after enrollment |
| Background |
| Day E, Hellard M, Treloar C, Bruneau J, Martin NK, Ovrehus A, Dalgard O, Lloyd A, Dillon J, Hickman M, Byrne J, Litwin A, Maticic M, Bruggmann P, Midgard H, Norton B, Trooskin S, Lazarus JV, Grebely J; International Network on Hepatitis in Substance Users (INHSU). Hepatitis C elimination among people who inject drugs: Challenges and recommendations for action within a health systems framework. Liver Int. 2019 Jan;39(1):20-30. doi: 10.1111/liv.13949. Epub 2018 Sep 22. |
| 28797498 | Background | Bajis S, Dore GJ, Hajarizadeh B, Cunningham EB, Maher L, Grebely J. Interventions to enhance testing, linkage to care and treatment uptake for hepatitis C virus infection among people who inject drugs: A systematic review. Int J Drug Policy. 2017 Sep;47:34-46. doi: 10.1016/j.drugpo.2017.07.002. Epub 2017 Aug 7. |
| 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. |
| 19175876 | Background | Foucher J, Reiller B, Jullien V, Leal F, di Cesare ES, Merrouche W, Delile JM, de Ledinghen V. FibroScan used in street-based outreach for drug users is useful for hepatitis C virus screening and management: a prospective study. J Viral Hepat. 2009 Feb;16(2):121-31. doi: 10.1111/j.1365-2893.2008.01050.x. Epub 2008 Oct 17. |
| 28275079 | Background | McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8. |
| 28160728 | Background | Gupta E, Agarwala P, Kumar G, Maiwall R, Sarin SK. Point -of -care testing (POCT) in molecular diagnostics: Performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection. J Clin Virol. 2017 Mar;88:46-51. doi: 10.1016/j.jcv.2017.01.006. Epub 2017 Jan 29. |
| 28442271 | Background | Grebely J, Lamoury FMJ, Hajarizadeh B, Mowat Y, Marshall AD, Bajis S, Marks P, Amin J, Smith J, Edwards M, Gorton C, Ezard N, Persing D, Kleman M, Cunningham P, Catlett B, Dore GJ, Applegate TL; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):514-520. doi: 10.1016/S2468-1253(17)30075-4. Epub 2017 Apr 22. |
| 24988388 | Background | Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014. |
| 28578863 | Background | Iversen J, Grebely J, Catlett B, Cunningham P, Dore GJ, Maher L. Estimating the cascade of hepatitis C testing, care and treatment among people who inject drugs in Australia. Int J Drug Policy. 2017 Sep;47:77-85. doi: 10.1016/j.drugpo.2017.05.022. Epub 2017 Jun 1. |
| 29534185 | Background | Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114. |
| 32106345 | Background | Bielen R, Koc OM, Busschots D, Verrando R, Nevens F, Robaeys G. Validation of hepatitis C virus RNA detection using capillary blood by finger prick (GenXpert system)-Hepatitis C fingerprick study. J Viral Hepat. 2020 Jul;27(7):709-714. doi: 10.1111/jvh.13284. Epub 2020 Mar 13. |
| 30388566 | Background | Bajis S, Maher L, Treloar C, Hajarizadeh B, Lamoury FMJ, Mowat Y, Schulz M, Marshall AD, Cunningham EB, Cock V, Ezard N, Gorton C, Hayllar J, Smith J, Whelan M, Martinello M, Applegate TL, Dore GJ, Grebely J; LiveRLife Study Group. Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia. Int J Drug Policy. 2018 Nov;61:23-30. doi: 10.1016/j.drugpo.2018.08.011. Epub 2018 Oct 25. |
| 32470849 | Background | Saludes V, Antuori A, Lazarus JV, Folch C, Gonzalez-Gomez S, Gonzalez N, Ibanez N, Colom J, Matas L, Casabona J, Martro E. Evaluation of the Xpert HCV VL Fingerstick point-of-care assay and dried blood spot HCV-RNA testing as simplified diagnostic strategies among people who inject drugs in Catalonia, Spain. Int J Drug Policy. 2020 Jun;80:102734. doi: 10.1016/j.drugpo.2020.102734. Epub 2020 May 26. |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |