HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels

NCT04610762 | Completed

• 1 other identifier: CE/20-10-01
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Keywords

Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick

  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

  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

Study Arms (1)

(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus

Diagnostic Test: GeneXpert HCV VL Fingerstick test

Interventions

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.

(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (ex) drug users
• a risk of Hepatitis C infection
• French speaking
• Either patient with a positive serology for HCV who have never performed HCV RNA by Polymerase chain reaction (PCR) by a peripheral venous sampling (due to difficult venous access, financial problem, medical insurance problem or other reasons) either patient with a suspicion of reinfection for whom the HCV RNA PCR by peripheral venous sampling is not reimbursed by health insurance

You may not qualify if:

• Age \<18 years
• Cepheid GeneXpert HCV VL Fingerstick will not use to assess the Sustained Virological Response (SVR) at 12 weeks after the end of an antiviral treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Cepheid: collaborator
• Réseau Hépatite C Bruxelles: collaborator
• Gilead Sciences: collaborator
• AbbVie: collaborator

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Related Publications (14)

• 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.

  PMID: 28683982 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.

  PMID: 30157316 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.

  PMID: 28797498 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.

  PMID: 26806260 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.

  PMID: 19175876 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.

  PMID: 28275079 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.

  PMID: 28160728 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.

  PMID: 28442271 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.

  PMID: 24988388 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.

  PMID: 28578863 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.

  PMID: 29534185 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.

  PMID: 32106345 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.

  PMID: 30388566 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.

  PMID: 32470849 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Drug Misuse

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jean-Pierre Mulkay, MD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

• Lise Meunier, MD

  ASBL Réseau Hépatite C Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: October 30, 2020
• Study Start: November 17, 2020
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

BE (1)