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SCANVIR: Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

Sponsor
University Hospital, Limoges (Other)
Overall Status
Recruiting
CT.gov ID
NCT05361603
Collaborator
(none)
1,500
Enrollment
1
Location
152.7
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Information on screening, the days are announced by :

    • Mailing to health professionals in the Haute-Vienne Department,

    • Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),

    • Flyers and posters in health care facilities,

    • Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),

    • Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.

    1. Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :

    Each patient presenting during the screening day will have an individualized welcome.

    Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).

    1. The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.

    2. One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.

    3. Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD

    4. Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.

    5. A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.

    Method for routine management of patients according to results :
    1. HCV HBV HIV TROD are negative and FibroScan® > 7.1 KPa:

    The patient meets directly with the hepatologist to screen for risk factors for chronic liver disease (alcohol, medications ...).

    1. The HCV HBV HIV TROD are negative and the FibroScan ® < 7.1 KPa :

    The nurse at the facility reviews with the patient the modes of transmission of the viruses and discusses with him/her risk reduction and harm reduction and what to do in case of recent exposure.

    1. Positive HCV TROD:

    The hepatologist offers to do an immediate and on-site HCV RNA by delocalized PCR (GeneXpert). If the HCV RNA is positive, HCV treatment is started immediately (excluding comorbidity). An appointment is proposed 3 months after treatment to control the cure by delocalized PCR on site (RVS12)

    1. HIV or HBV TROD positivity:

    The hepatologist proposes to do immediately and on site a complete blood test (HIV serology, HBV serologies (HBsAg, HBcAb, HBsAb) by the nurse present, assesses other risk factors and schedules an appointment for the results and management.

    For all situations, a prevention action to reduce the risks of transmission of HCV and HBV will be carried out at the same time.

    An anti-viral B vaccination may be offered.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan
    Actual Study Start Date :
    May 24, 2017
    Anticipated Primary Completion Date :
    Dec 9, 2022
    Anticipated Study Completion Date :
    Feb 14, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Number of RTDs performed compared to the number proposed [up to 10 years]

      Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®

    2. Number of FibroScan® performed compared to the number proposed [up to 10 years]

      Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®

    Secondary Outcome Measures

    1. Number of days actually completed and the number of participants per session [up to 10 years]

      Evaluate the feasibility of simultaneous screening for viral hepatitis B, C and HIV in drug users in non-conventional structures using a dual screening method TROD and FibroScan®

    2. Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist [up to 10 years]

      Evaluate the acceptability of risk reduction methods as part of the care pathway.

    3. Number of patients who had social care [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    4. Number of anti-viral B vaccinations offered and carried out [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    5. Number of GeneXperts performed compared to the number proposed [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    6. The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    7. Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients, [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    8. The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients [up to 10 years]

      Evaluate the impact of screening in terms of patient care.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult 18 and over

    • Patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector

    • Patient who agreed to participate to the research

    Exclusion Criteria:
    • Patient doesn't agree to participate to the research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Limoges Limoges Haute Vienne France 87042

    Sponsors and Collaborators

    • University Hospital, Limoges

    Investigators

    • Principal Investigator: Marilyne DEBETTE-GRATIEN, MD, Hôpital Dupuytren

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT05361603
    Other Study ID Numbers:
    • I17011_SCANVIR
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Limoges
    hepatitis C
    Elimination
    HBV
    HIV
    PWID
    Addiction
    Care structure
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis B
    Hepatitis
    Alcoholism
    Behavior, Addictive

    Study Results

    No Results Posted as of May 4, 2022