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® (SCANVIRE2)

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.

Study Overview

• Status: Recruiting
• Conditions: Viral Hepatitis

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 Type: Observational
• Enrollment (Estimated): 2300

Contacts and Locations

• Study Contact: Name: Marilyne DEBETTE-GRATIEN, MD; Phone Number: +33555056604; Email: marilyne.gratien@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87000
    • Recruiting
    • Limoges University hospital
    • Principal Investigator: Marilyne DEBETTE-GRATIEN, MD
    • Contact: Marilyne DEBETTE-GRATIEN, MD; Phone Number: 0555056604; Email: marilyne.gratien@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

drug users and vulnerable populations in non-conventional structures

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from enrollment to the end of the subject participation at the end of the day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reinforce screening for hepatitis B (HBV), hepatitis Delta (HDV) and HIV,	Number and proportion of patients who accepted immediate consultation with the hepatologist,	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	from enrollment to the end of the subject participation at the end of the day
Encourage HBV vaccination,	Number of HBV vaccinations offered,	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,	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,	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,	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,	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 ®.	from enrollment to the end of the subject participation at the end of the day

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: marilyne DEBETTE-GRATIEN, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Estimated): June 5, 2035
• Study Completion (Estimated): June 5, 2035

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: HCV; eradication; marginalized patients
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis A; Hepatitis; Hepatitis B
• Other Study ID Numbers: 87RI24_0061 (SCANVIRE2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No