Clinical trial NCT05361603: Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Transmission, Intravenous Drug Abuser
Addiction, Alcohol
Addiction Opiate
Hepatitis C Virus Infection, Response to Therapy of
Keywords: hepatitis C
Elimination
HBV
HIV
PWID
Addiction
Care structure
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People followed in unconventional structure care

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.

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.
2. 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 ...).
2. 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.
3. 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)
4. 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.

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 who agreed to participate to the research

Exclusion Criteria:

* Patient doesn't agree to participate to the research

Primary outcomes:
measure: Number of RTDs performed compared to the number proposed
timeFrame: up to 10 years
measure: Number of FibroScan® performed compared to the number proposed
timeFrame: up to 10 years
Secondary outcomes:
measure: Number of days actually completed and the number of participants per session
timeFrame: up to 10 years
measure: Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist
timeFrame: up to 10 years
measure: Number of patients who had social care
timeFrame: up to 10 years
measure: Number of anti-viral B vaccinations offered and carried out
timeFrame: up to 10 years
measure: Number of GeneXperts performed compared to the number proposed
timeFrame: up to 10 years
measure: The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication
timeFrame: up to 10 years
measure: Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients,
timeFrame: up to 10 years
measure: The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Limoges
country: France
facility: Chu Limoges
state: Haute Vienne
Study officials:
affiliation: Hôpital Dupuytren
name: Marilyne DEBETTE-GRATIEN, MD
role: PRINCIPAL_INVESTIGATOR
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