Hepatitis CSCANVIRNCT05361603
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
An observational study of Hepatitis C and Transmission, Intravenous Drug Abuser, run by University Hospital, Limoges at 1 site in France.
Trial summary
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Transmission, Intravenous Drug Abuser, Addiction, Alcohol
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2017to 14 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: People followed in unconventional structure care
Who may be able to join
- Adult 18 and over
- Patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector
- Patient who agreed to participate to the research
Who cannot join
- Patient doesn't agree to participate to the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Limoges
Limoges, Haute Vienne, 87042
FRANCOIS Sandrine, PhD, 33 5 19 76 17 66, sandrine.francois@chu-limoges.fr
Céline RIGAUD, MSc, 33 5 55 05 60 52, celine.rigaud@chu-limoges.fr
About this study
Official title: Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.
Read the detailed description
- Information on screening, the days are announced by :
- Mailing to health professionals in the Haute-Vienne Department,
- Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),
- Flyers and posters in health care facilities,
- Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),
- Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.
- Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :
Each patient presenting during the screening day will have an individualized welcome.
Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).
- The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.
- One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.
- Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD
- Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.
- A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.
Method for routine management of patients according to results :
- HCV HBV HIV TROD are negative and FibroScan® > 7.1 KPa: The patient meets directly with the hepatologist to screen for risk factors for chronic liver disease (alcohol, medications ...).
- The HCV HBV HIV TROD are negative and the FibroScan ® < 7.1 KPa : The nurse at the facility reviews with the patient the modes of transmission of the viruses and discusses with him/her risk reduction and harm reduction and what to do in case of recent exposure.
- Positive HCV TROD: The hepatologist offers to do an immediate and on-site HCV RNA by delocalized PCR (GeneXpert). If the HCV RNA is positive, HCV treatment is started immediately (excluding comorbidity). An appointment is proposed 3 months after treatment to control the cure by delocalized PCR on site (RVS12)
- HIV or HBV TROD positivity:
The hepatologist proposes to do immediately and on site a complete blood test (HIV serology, HBV serologies (HBsAg, HBcAb, HBsAb) by the nurse present, assesses other risk factors and schedules an appointment for the results and management.
For all situations, a prevention action to reduce the risks of transmission of HCV and HBV will be carried out at the same time.
An anti-viral B vaccination may be offered.
- Conditions
- Hepatitis C, Transmission, Intravenous Drug Abuser, Addiction, Alcohol, Addiction Opiate, Hepatitis C Virus Infection, Response to Therapy of
- Keywords
- hepatitis C, Elimination, HBV, HIV, PWID, Addiction, Care structure
- Medical subject headings
- Hepatitis C, Alcoholism, Opioid-Related Disorders, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RTDs performed compared to the number proposed
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
Measured: up to 10 years
Number of FibroScan® performed compared to the number proposed
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
Measured: up to 10 years
Secondary outcomes (8)
Number of days actually completed and the number of participants per session
Evaluate the feasibility of simultaneous screening for viral hepatitis B, C and HIV in drug users in non-conventional structures using a dual screening method TROD and FibroScan®
Measured: up to 10 years
Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist
Evaluate the acceptability of risk reduction methods as part of the care pathway.
Measured: up to 10 years
Number of patients who had social care
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
Number of anti-viral B vaccinations offered and carried out
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
Number of GeneXperts performed compared to the number proposed
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients,
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients
Evaluate the impact of screening in terms of patient care.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start24 May 2017
- Primary completion9 Dec 2022 (estimated)
- Study completion14 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyne DEBETTE-GRATIEN, MD, Principal investigator, Hôpital Dupuytren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361603
- Sponsor's protocol ID
- I17011_SCANVIR
- Acronym
- SCANVIR
- Status last verified
- Feb 2022
- First submitted
- 29 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Razavi H, Sanchez Gonzalez Y, Yuen C, Cornberg M. Global timing of hepatitis C virus elimination in high-income countries. Liver Int. 2020 Mar;40(3):522-529. doi: 10.1111/liv.14324. Epub 2019 Dec 23.
PubMed 31815353Tran A, Shili-Masmoudi S, Moga L, Chevaliez S, Luciani A, Ruiz I, Ganne-Carrie N, Bureau C, Bourliere M, de Ledinghen V. Non-invasive diagnosis and follow-up of chronic infection with Hepatitis C Virus. Clin Res Hepatol Gastroenterol. 2022 Jan;46(1):101771. doi: 10.1016/j.clinre.2021.101771. Epub 2021 Jul 28.
PubMed 34332129Pol S, Lagaye S. The remarkable history of the hepatitis C virus. Genes Immun. 2019 May;20(5):436-446. doi: 10.1038/s41435-019-0066-z. Epub 2019 Apr 25.
PubMed 31019253Brouard C, Pillonel J, Boussac M, de Ledinghen V, Rachas A, Silvain C, Lydie N, Chevaliez S, Pioche C, Durand J, Lot F, Delarocque-Astagneau E. French hepatitis C care cascade: substantial impact of direct-acting antivirals, but the road to elimination is still long. BMC Infect Dis. 2020 Oct 15;20(1):759. doi: 10.1186/s12879-020-05478-6.
PubMed 33059617Brouard C, Saboni L, Gautier A, Chevaliez S, Rahib D, Richard JB, Barin F, Larsen C, Sommen C, Pillonel J, Delarocque-Astagneau E, Lydie N, Lot F; 2016 Health Barometer Group. HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy. BMC Infect Dis. 2019 Oct 28;19(1):896. doi: 10.1186/s12879-019-4493-2.
PubMed 31660879Bajis S, Grebely J, Hajarizadeh B, Applegate T, Marshall AD, Ellen Harrod M, Byrne J, Bath N, Read P, Edwards M, Gorton C, Hayllar J, Cock V, Peterson S, Thomson C, Weltman M, Jefferies M, Wood W, Haber P, Ezard N, Martinello M, Maher L, Dore GJ; LiveRLife Study Group. Hepatitis C virus testing, liver disease assessment and treatment uptake among people who inject drugs pre- and post-universal access to direct-acting antiviral treatment in Australia: The LiveRLife study. J Viral Hepat. 2020 Mar;27(3):281-293. doi: 10.1111/jvh.13233. Epub 2019 Dec 6.
PubMed 31698545Chevaliez S. Strategies for the improvement of HCV testing and diagnosis. Expert Rev Anti Infect Ther. 2019 May;17(5):341-347. doi: 10.1080/14787210.2019.1604221. Epub 2019 Apr 22.
PubMed 30950298Smookler D, Vanderhoff A, Biondi MJ, Valencia J, Ryan P, Karkada J, Hong R, Sattar I, Mandel E, Gjevori M, Casey J, Fletcher D, Shah H, Hansen BE, Capraru C, Janssen HLA, Lazarus JV, Feld JJ. Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1451-1458.e4. doi: 10.1016/j.cgh.2020.07.058. Epub 2020 Aug 4.
PubMed 32763480Debette-Gratien M, Francois S, Chevalier C, Alain S, Carrier P, Rigaud C, Abraham B, Burgevin AL, Courat L, Debenes B, Koffi J, Caux-Nussbaum E, Zattoni-Leroy J, Feuillet-Sow G, Dumont Q, Nubukpo P, Loustaud-Ratti V. Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days. J Viral Hepat. 2023 Apr;30(4):355-361. doi: 10.1111/jvh.13798. Epub 2023 Jan 11.
PubMed 36597183
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan
- ClinicalTrials.gov ID
- NCT05361603
- Acronym / sponsor ID
- SCANVIR / I17011_SCANVIR
- Conditions
- Hepatitis C, Transmission, Intravenous Drug Abuser, Addiction, Alcohol, Addiction Opiate, Hepatitis C Virus Infection, Response to Therapy of
- Keywords
- hepatitis C, Elimination, HBV, HIV, PWID, Addiction, Care structure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 9 Dec 2022 (estimated)
- Study completion
- 14 Feb 2030 (estimated)
- First posted
- 4 May 2022 (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.
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.
Detailed description
- Information on screening, the days are announced by :
- Mailing to health professionals in the Haute-Vienne Department,
- Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),
- Flyers and posters in health care facilities,
- Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),
- Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.
- Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :
Each patient presenting during the screening day will have an individualized welcome.
Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).
- The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.
- One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.
- Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD
- Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.
- A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.
Method for routine management of patients according to results :
- HCV HBV HIV TROD are negative and FibroScan® > 7.1 KPa: The patient meets directly with the hepatologist to screen for risk factors for chronic liver disease (alcohol, medications ...).
- The HCV HBV HIV TROD are negative and the FibroScan ® < 7.1 KPa : The nurse at the facility reviews with the patient the modes of transmission of the viruses and discusses with him/her risk reduction and harm reduction and what to do in case of recent exposure.
- Positive HCV TROD: The hepatologist offers to do an immediate and on-site HCV RNA by delocalized PCR (GeneXpert). If the HCV RNA is positive, HCV treatment is started immediately (excluding comorbidity). An appointment is proposed 3 months after treatment to control the cure by delocalized PCR on site (RVS12)
- HIV or HBV TROD positivity:
The hepatologist proposes to do immediately and on site a complete blood test (HIV serology, HBV serologies (HBsAg, HBcAb, HBsAb) by the nurse present, assesses other risk factors and schedules an appointment for the results and management.
For all situations, a prevention action to reduce the risks of transmission of HCV and HBV will be carried out at the same time.
An anti-viral B vaccination may be offered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People followed in unconventional structure care
Key inclusion criteria (3 listed)
- Adult 18 and over
- Patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector
- Patient who agreed to participate to the research
Key exclusion criteria (1 listed)
- Patient doesn't agree to participate to the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of RTDs performed compared to the number proposed
Time frame: up to 10 years
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
Number of FibroScan® performed compared to the number proposed
Time frame: up to 10 years
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
8 secondary outcomes
Number of days actually completed and the number of participants per session
Time frame: up to 10 years
Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist
Time frame: up to 10 years
Number of patients who had social care
Time frame: up to 10 years
Number of anti-viral B vaccinations offered and carried out
Time frame: up to 10 years
Number of GeneXperts performed compared to the number proposed
Time frame: up to 10 years
The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication
Time frame: up to 10 years
Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients,
Time frame: up to 10 years
The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 31815353Razavi H, Sanchez Gonzalez Y, Yuen C, Cornberg M. Global timing of hepatitis C virus elimination in high-income countries. Liver Int. 2020 Mar;40(3):522-529. doi: 10.1111/liv.14324. Epub 2019 Dec 23.
- Background: PubMed 34332129Tran A, Shili-Masmoudi S, Moga L, Chevaliez S, Luciani A, Ruiz I, Ganne-Carrie N, Bureau C, Bourliere M, de Ledinghen V. Non-invasive diagnosis and follow-up of chronic infection with Hepatitis C Virus. Clin Res Hepatol Gastroenterol. 2022 Jan;46(1):101771. doi: 10.1016/j.clinre.2021.101771. Epub 2021 Jul 28.
- Background: PubMed 31019253Pol S, Lagaye S. The remarkable history of the hepatitis C virus. Genes Immun. 2019 May;20(5):436-446. doi: 10.1038/s41435-019-0066-z. Epub 2019 Apr 25.
- Background: PubMed 33059617Brouard C, Pillonel J, Boussac M, de Ledinghen V, Rachas A, Silvain C, Lydie N, Chevaliez S, Pioche C, Durand J, Lot F, Delarocque-Astagneau E. French hepatitis C care cascade: substantial impact of direct-acting antivirals, but the road to elimination is still long. BMC Infect Dis. 2020 Oct 15;20(1):759. doi: 10.1186/s12879-020-05478-6.
- Background: PubMed 31660879Brouard C, Saboni L, Gautier A, Chevaliez S, Rahib D, Richard JB, Barin F, Larsen C, Sommen C, Pillonel J, Delarocque-Astagneau E, Lydie N, Lot F; 2016 Health Barometer Group. HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy. BMC Infect Dis. 2019 Oct 28;19(1):896. doi: 10.1186/s12879-019-4493-2.
- Background: PubMed 31698545Bajis S, Grebely J, Hajarizadeh B, Applegate T, Marshall AD, Ellen Harrod M, Byrne J, Bath N, Read P, Edwards M, Gorton C, Hayllar J, Cock V, Peterson S, Thomson C, Weltman M, Jefferies M, Wood W, Haber P, Ezard N, Martinello M, Maher L, Dore GJ; LiveRLife Study Group. Hepatitis C virus testing, liver disease assessment and treatment uptake among people who inject drugs pre- and post-universal access to direct-acting antiviral treatment in Australia: The LiveRLife study. J Viral Hepat. 2020 Mar;27(3):281-293. doi: 10.1111/jvh.13233. Epub 2019 Dec 6.
- Background: PubMed 30950298Chevaliez S. Strategies for the improvement of HCV testing and diagnosis. Expert Rev Anti Infect Ther. 2019 May;17(5):341-347. doi: 10.1080/14787210.2019.1604221. Epub 2019 Apr 22.
- Background: PubMed 32763480Smookler D, Vanderhoff A, Biondi MJ, Valencia J, Ryan P, Karkada J, Hong R, Sattar I, Mandel E, Gjevori M, Casey J, Fletcher D, Shah H, Hansen BE, Capraru C, Janssen HLA, Lazarus JV, Feld JJ. Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1451-1458.e4. doi: 10.1016/j.cgh.2020.07.058. Epub 2020 Aug 4.
- Derived from this study: PubMed 36597183Debette-Gratien M, Francois S, Chevalier C, Alain S, Carrier P, Rigaud C, Abraham B, Burgevin AL, Courat L, Debenes B, Koffi J, Caux-Nussbaum E, Zattoni-Leroy J, Feuillet-Sow G, Dumont Q, Nubukpo P, Loustaud-Ratti V. Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days. J Viral Hepat. 2023 Apr;30(4):355-361. doi: 10.1111/jvh.13798. Epub 2023 Jan 11.
- Individual participant dataSharing planned: No
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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.
Marilyne DEBETTE-GRATIEN, MD principal investigator
Hôpital Dupuytren
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 and Transmission, Intravenous Drug Abuser, run by University Hospital, Limoges at 1 site in France.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 May 2022. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyne DEBETTE-GRATIEN, MD (33 5 55 05 87 26, MARILYNE.GRATIEN@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RTDs performed compared to the number proposed (time frame: up to 10 years). The study lists 2 primary outcomes in all. 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 NCT05361603, which also lists 9 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 4 May 2022.