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NCT Number: NCT06904820

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®

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges University Hospital

Limoges, 87000, France

Location status: Recruiting

Location contact

Marilyne DEBETTE-GRATIEN, MD

CONTACT

[email protected]

0555056604

Marilyne DEBETTE-GRATIEN, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Number and proportion of patients who accepted immediate consultation with the hepatologist,

  2. 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

    Number and proportion of patients who accepted risk prevention education by the nurse

  3. Encourage HBV vaccination,

    Time frame: from enrollment to the end of the subject participation at the end of the day

    Number of HBV vaccinations offered,

  4. Evaluate the feasibility of PCR (GeneXpert/Buvard),

    Time frame: from enrollment to the end of the subject participation at the end of the day

    Number of GeneXpert PCRs performed, Number of PCRs performed on blotting paper,

  5. 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

    Number and proportion of patients who have accepted risk prevention education from the nurse,

  6. Provide social support,

    Time frame: from enrollment to the end of the subject participation at the end of the day

    Number of patients who received social support,

  7. 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

    Absolute number and proportion of patients treated or not maintained in care,

  8. 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

    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 ®.

Study contacts

Contact information is provided by the study sponsor or research team.

Marilyne DEBETTE-GRATIEN, MD

CONTACT

[email protected]

+33555056604

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: SCANVIRE2

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Apr 1, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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