Clinical trial 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®
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®
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Viral Hepatitis
Keywords: HCV
eradication
marginalized patients
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drug users and vulnerable populations in non-conventional structures

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.

Eligibility criteria: 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

Primary outcomes:
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®.
timeFrame: from enrollment to the end of the subject participation at the end of the day
Secondary outcomes:
measure: Reinforce screening for hepatitis B (HBV), hepatitis Delta (HDV) and HIV,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Reinforce education to prevent the risk of viral transmission,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Encourage HBV vaccination,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Evaluate the feasibility of PCR (GeneXpert/Buvard),
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Reinforce education to prevent the risk of viral transmission,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Provide social support,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Offer rapid treatment to HCV-positive patients in precarious situations,
timeFrame: from enrollment to the end of the subject participation at the end of the day
measure: Assess associated co-morbidities: alcohol, cannabis, drug misuse, associated psychiatric pathologies,
timeFrame: from enrollment to the end of the subject participation at the end of the day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Limoges
name: Véronqiue LOUSTAUD-RATTI, MD
role: PRINCIPAL_INVESTIGATOR
References: