Viral HepatitisSCANVIRE2NCT06904820
Acceptability and Feasibility of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users and Vulnerable Populations, in Non-conventional Structures "Outside the Walls" by Dual Screening Method RTDs and FibroScan®
An observational study of Viral Hepatitis, run by University Hospital, Limoges at 1 site in France.
Trial summary
The "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Hepatitis
- How many people
- 2,300 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2025to 5 Jun 2035
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: drug users and vulnerable populations in non-conventional structures
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 not opposed to research
Who cannot join
- Age under 18
- Patient opposed to 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
Limoges University Hospital
Limoges, 87000
Marilyne DEBETTE-GRATIEN, MD, 0555056604, marilyne.gratien@chu-limoges.fr
Marilyne DEBETTE-GRATIEN, MD
About this study
The "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. The main objective of the SCANVIR project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for PWIDs and vulnerable populations during dedicated days in addiction care centers.
Read the detailed description
According to the French recommendations, eliminating hepatitis C virus by 2025 could be a realistic public health goal in this country. A total of 71,466 patients had treatment initiation between 2015 and 2019. It is estimated that 100 000 people are still infected in 2019.
To meet these ambitious objectives, effective screening policies should be intensified and access to treatment promoted through new care strategies for patients who escape the usual care pathways i.e. people who inject drugs (PWIDs), prisoners, migrants and vulnerable populations.
PWIDs represent a large proportion of patients to be screened and treated. It's still not possible to accurately evaluate the number of drug users who are infected with HCV (45 000 people estimated).
Drug users sharing needles and syringes have poor access to treatment. Dealing with PWIDs in addiction care centers (CSAPA and CAARUD in France) is one way to promote HCV testing, and to keep them in the care pathway. This population requires dedicated models that reduce barriers to care: harm reductions policies, access to therapy in real time and follow-up for the detection of reinfection. So the investigator designed and applied a new innovative concept to test, treat and cure PWIDs in their own environment, called the SCANVIR program, initially tested in four French departments with a regional and now national extension.
- Conditions
- Viral Hepatitis
- Keywords
- HCV, eradication, marginalized patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the acceptability and the feasibility of simultaneous screening for viral hepatitis B, C and HIV among drug users and vulnerable populations in non-conventional structures using a triple method with RTD and FibroScan® and GeneXpert®.
Feasibility will be assessed by the number of days and the number of participants in all sessions.
the acceptability of TROD and/or Fibroscan will be assessed by the number and proportion of double screenings (TROD and/or Fibroscan) performed in relation to the number of screenings offered
Measured: from enrollment to the end of the subject participation at the end of the day
Secondary outcomes (8)
Reinforce screening for hepatitis B (HBV), hepatitis Delta (HDV) and HIV,
Number and proportion of patients who accepted immediate consultation with the hepatologist,
Measured: from enrollment to the end of the subject participation at the end of the day
Reinforce education to prevent the risk of viral transmission,
Number and proportion of patients who accepted risk prevention education by the nurse
Measured: from enrollment to the end of the subject participation at the end of the day
Encourage HBV vaccination,
Number of HBV vaccinations offered,
Measured: from enrollment to the end of the subject participation at the end of the day
Evaluate the feasibility of PCR (GeneXpert/Buvard),
Number of GeneXpert PCRs performed, Number of PCRs performed on blotting paper,
Measured: from enrollment to the end of the subject participation at the end of the day
Reinforce education to prevent the risk of viral transmission,
Number and proportion of patients who have accepted risk prevention education from the nurse,
Measured: from enrollment to the end of the subject participation at the end of the day
Provide social support,
Number of patients who received social support,
Measured: from enrollment to the end of the subject participation at the end of the day
Offer rapid treatment to HCV-positive patients in precarious situations,
Absolute number and proportion of patients treated or not maintained in care,
Measured: from enrollment to the end of the subject participation at the end of the day
Assess associated co-morbidities: alcohol, cannabis, drug misuse, associated psychiatric pathologies,
Number of patients with one or more risk factors for chronic liver disease, whether or not associated with chronic viral hepatitis or HIV infection: alcohol, metabolic syndrome, cannabis, drugs detected by FibroScan ®.
Measured: from enrollment to the end of the subject participation at the end of the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start5 Jun 2025
- Primary completion5 Jun 2035 (estimated)
- Study completion5 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral HepatitisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- marilyne DEBETTE-GRATIEN, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904820
- Sponsor's protocol ID
- 87RI24_0061 (SCANVIRE2)
- Acronym
- SCANVIRE2
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users and Vulnerable Populations, in Non-conventional Structures "Outside the Walls" by Dual Screening Method RTDs and FibroScan®
- ClinicalTrials.gov ID
- NCT06904820
- Acronym / sponsor ID
- SCANVIRE2 / 87RI24_0061 (SCANVIRE2)
- Conditions
- Viral Hepatitis
- Keywords
- HCV, eradication, marginalized patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 5 Jun 2035 (estimated)
- Study completion
- 5 Jun 2035 (estimated)
- First posted
- 1 Apr 2025 (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 "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. The main objective of the SCANVIR project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for PWIDs and vulnerable populations during dedicated days in addiction care centers.
Detailed description
According to the French recommendations, eliminating hepatitis C virus by 2025 could be a realistic public health goal in this country. A total of 71,466 patients had treatment initiation between 2015 and 2019. It is estimated that 100 000 people are still infected in 2019.
To meet these ambitious objectives, effective screening policies should be intensified and access to treatment promoted through new care strategies for patients who escape the usual care pathways i.e. people who inject drugs (PWIDs), prisoners, migrants and vulnerable populations.
PWIDs represent a large proportion of patients to be screened and treated. It's still not possible to accurately evaluate the number of drug users who are infected with HCV (45 000 people estimated).
Drug users sharing needles and syringes have poor access to treatment. Dealing with PWIDs in addiction care centers (CSAPA and CAARUD in France) is one way to promote HCV testing, and to keep them in the care pathway. This population requires dedicated models that reduce barriers to care: harm reductions policies, access to therapy in real time and follow-up for the detection of reinfection. So the investigator designed and applied a new innovative concept to test, treat and cure PWIDs in their own environment, called the SCANVIR program, initially tested in four French departments with a regional and now national extension.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- drug users and vulnerable populations in non-conventional structures
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 not opposed to research
Key exclusion criteria (2 listed)
- Age under 18
- Patient opposed to 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
Evaluate the acceptability and the feasibility of simultaneous screening for viral hepatitis B, C and HIV among drug users and vulnerable populations in non-conventional structures using a triple method with RTD and FibroScan® and GeneXpert®.
Time frame: from enrollment to the end of the subject participation at the end of the day
Feasibility will be assessed by the number of days and the number of participants in all sessions. the acceptability of TROD and/or Fibroscan will be assessed by the number and proportion of double screenings (TROD and/or Fibroscan) performed in relation to the number of screenings offered
8 secondary outcomes
Reinforce screening for hepatitis B (HBV), hepatitis Delta (HDV) and HIV,
Time frame: from enrollment to the end of the subject participation at the end of the day
Reinforce education to prevent the risk of viral transmission,
Time frame: from enrollment to the end of the subject participation at the end of the day
Encourage HBV vaccination,
Time frame: from enrollment to the end of the subject participation at the end of the day
Evaluate the feasibility of PCR (GeneXpert/Buvard),
Time frame: from enrollment to the end of the subject participation at the end of the day
Reinforce education to prevent the risk of viral transmission,
Time frame: from enrollment to the end of the subject participation at the end of the day
Provide social support,
Time frame: from enrollment to the end of the subject participation at the end of the day
Offer rapid treatment to HCV-positive patients in precarious situations,
Time frame: from enrollment to the end of the subject participation at the end of the day
Assess associated co-morbidities: alcohol, cannabis, drug misuse, associated psychiatric pathologies,
Time frame: from enrollment to the end of the subject participation at the end of the day
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 14 Aug 2025.
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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
University Hospital, Limoges
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 Viral Hepatitis, 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 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 (+33555056604, 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?
Evaluate the acceptability and the feasibility of simultaneous screening for viral hepatitis B, C and HIV among drug users and vulnerable populations in non-conventional structures using a triple method with RTD and FibroScan® and GeneXpert®. (time frame: from enrollment to the end of the subject participation at the end of the day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.