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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®

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®

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06904820
Acronym
SCANVIRE2
Enrollment
2300
Registered
2025-04-01
Start date
2025-06-05
Completion date
2035-06-05
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral Hepatitis

Keywords

HCV, eradication, marginalized patients

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age under 18 * Patient opposed to research

Design outcomes

Primary

MeasureTime frameDescription
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®.from enrollment to the end of the subject participation at the end of the dayFeasibility 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

Secondary

MeasureTime frameDescription
Reinforce education to prevent the risk of viral transmission,from enrollment to the end of the subject participation at the end of the dayNumber and proportion of patients who accepted risk prevention education by the nurse
Encourage HBV vaccination,from enrollment to the end of the subject participation at the end of the dayNumber of HBV vaccinations offered,
Evaluate the feasibility of PCR (GeneXpert/Buvard),from enrollment to the end of the subject participation at the end of the dayNumber of GeneXpert PCRs performed, Number of PCRs performed on blotting paper,
Reinforce screening for hepatitis B (HBV), hepatitis Delta (HDV) and HIV,from enrollment to the end of the subject participation at the end of the dayNumber and proportion of patients who accepted immediate consultation with the hepatologist,
Offer rapid treatment to HCV-positive patients in precarious situations,from enrollment to the end of the subject participation at the end of the dayAbsolute number and proportion of patients treated or not maintained in care,
Assess associated co-morbidities: alcohol, cannabis, drug misuse, associated psychiatric pathologies,from enrollment to the end of the subject participation at the end of the dayNumber 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 ®.
Provide social support,from enrollment to the end of the subject participation at the end of the dayNumber of patients who received social support,

Countries

France

Contacts

Primary ContactMarilyne DEBETTE-GRATIEN, MD
marilyne.gratien@chu-limoges.fr+33555056604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026