Hepatitis C, ChronicNCT04610762

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

An observational study of Hepatitis C, Chronic, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: GeneXpert HCV VL Fingerstick test
How many people: 103 participants
Where: 1 siteBelgium
Study dates: 17 Nov 2020to 17 Nov 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

(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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

CHU Saint-Pierre
Brussels, 1000

Other trials in Belgium

About this study

Official title: Using the Cepheid GeneXpert HCV VL Fingerstick Test as a Diagnostic Tool for Chronic Hepatitis C Among Drug Users in Brussels

Conditions: Hepatitis C, Chronic
Being tested: GeneXpert HCV VL Fingerstick test
Keywords: Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care
Medical subject headings: Hepatitis C, Chronic, Drug Misuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GeneXpert HCV VL Fingerstick testDiagnostic 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.

Study groups in NCT04610762
Study group	Role	What they receive
(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus		Not described Receives: Diagnostic Test: GeneXpert HCV VL Fingerstick test

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches
Measured: 1 year after the start of recruitment

Secondary outcomes (6)

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
Measured: 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
Measured: 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
Measured: 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
Measured: one year after enrollment
Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment
Measured: 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)
Measured: up one year after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202017 Nov 2022

First posted30 Oct 2020
Study start17 Nov 2020
Primary completion17 Nov 2021
Study completion17 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04610762
Sponsor's protocol ID: CE/20-10-01
Status last verified: May 2023
First submitted: 29 Oct 2020
Last updated: 6 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 28683982
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.
PubMed 30157316
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.
PubMed 28797498
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.
PubMed 26806260
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.
PubMed 19175876
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.
PubMed 28275079
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.
PubMed 28160728
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.
PubMed 28442271
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.
PubMed 24988388
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.
PubMed 28578863
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.
PubMed 29534185
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.
PubMed 32106345
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.
PubMed 30388566
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.
PubMed 32470849

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using the Cepheid GeneXpert HCV VL Fingerstick Test as a Diagnostic Tool for Chronic Hepatitis C Among Drug Users in Brussels
ClinicalTrials.gov ID: NCT04610762
Acronym / sponsor ID: CE/20-10-01
Conditions: Hepatitis C, Chronic
Keywords: Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care
Study type: Observational
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
Collaborators: Cepheid, Réseau Hépatite C Bruxelles, Gilead Sciences, AbbVie
Study start: 17 Nov 2020 (actual)
Primary completion: 17 Nov 2021 (actual)
Study completion: 17 Nov 2022 (actual)
First posted: 30 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus	–	Diagnostic Test: GeneXpert HCV VL Fingerstick test

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (4 listed)

(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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GeneXpert HCV VL Fingerstick testThe 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.	Diagnostic test	(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus

Primary outcome

Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches
Time frame: 1 year after the start of recruitment

6 secondary outcomes

Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: one year after enrollment
Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment
Time frame: 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)
Time frame: up one year after enrollment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Background: PubMed 28683982Grebely 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.
Background: PubMed 30157316Day 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.
Background: PubMed 28797498Bajis 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.
Background: PubMed 26806260Chevaliez 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.
Background: PubMed 19175876Foucher 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.
Background: PubMed 28275079McHugh 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.
Background: PubMed 28160728Gupta 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.
Background: PubMed 28442271Grebely 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.
Background: PubMed 24988388Yehia 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.
Background: PubMed 28578863Iversen 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.
Background: PubMed 29534185Lamoury 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.
Background: PubMed 32106345Bielen 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Pierre Mulkay, MD principal investigator

Centre Hospitalier Universitaire Saint Pierre

Lise Meunier, MD principal investigator

ASBL Réseau Hépatite C Bruxelles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches (time frame: 1 year after the start of recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610762, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.