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

NCT05361603 | Recruiting

• 1 other identifier: I17011_SCANVIR
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of RTDs performed compared to the number proposed

  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®

  up to 10 years

• Number of FibroScan® performed compared to the number proposed

  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®

  up to 10 years

Secondary Outcomes (8)

• Number of days actually completed and the number of participants per session

  up to 10 years

• Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist

  up to 10 years

• Number of patients who had social care

  up to 10 years

• Number of anti-viral B vaccinations offered and carried out

  up to 10 years

• Number of GeneXperts performed compared to the number proposed

  up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People followed in unconventional structure care

You may qualify if:

• 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

You may not qualify if:

• Patient doesn't agree to participate to the research

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Chu Limoges

Limoges, Haute Vienne, 87042, France

RECRUITING

Related Publications (9)

• Razavi H, Sanchez Gonzalez Y, Yuen C, Cornberg M. Global timing of hepatitis C virus elimination in high-income countries. Liver Int. 2020 Mar;40(3):522-529. doi: 10.1111/liv.14324. Epub 2019 Dec 23.

  PMID: 31815353 BACKGROUND

• Tran A, Shili-Masmoudi S, Moga L, Chevaliez S, Luciani A, Ruiz I, Ganne-Carrie N, Bureau C, Bourliere M, de Ledinghen V. Non-invasive diagnosis and follow-up of chronic infection with Hepatitis C Virus. Clin Res Hepatol Gastroenterol. 2022 Jan;46(1):101771. doi: 10.1016/j.clinre.2021.101771. Epub 2021 Jul 28.

  PMID: 34332129 BACKGROUND

• Pol S, Lagaye S. The remarkable history of the hepatitis C virus. Genes Immun. 2019 May;20(5):436-446. doi: 10.1038/s41435-019-0066-z. Epub 2019 Apr 25.

  PMID: 31019253 BACKGROUND

• Brouard C, Pillonel J, Boussac M, de Ledinghen V, Rachas A, Silvain C, Lydie N, Chevaliez S, Pioche C, Durand J, Lot F, Delarocque-Astagneau E. French hepatitis C care cascade: substantial impact of direct-acting antivirals, but the road to elimination is still long. BMC Infect Dis. 2020 Oct 15;20(1):759. doi: 10.1186/s12879-020-05478-6.

  PMID: 33059617 BACKGROUND

• Brouard C, Saboni L, Gautier A, Chevaliez S, Rahib D, Richard JB, Barin F, Larsen C, Sommen C, Pillonel J, Delarocque-Astagneau E, Lydie N, Lot F; 2016 Health Barometer Group. HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy. BMC Infect Dis. 2019 Oct 28;19(1):896. doi: 10.1186/s12879-019-4493-2.

  PMID: 31660879 BACKGROUND

• Bajis S, Grebely J, Hajarizadeh B, Applegate T, Marshall AD, Ellen Harrod M, Byrne J, Bath N, Read P, Edwards M, Gorton C, Hayllar J, Cock V, Peterson S, Thomson C, Weltman M, Jefferies M, Wood W, Haber P, Ezard N, Martinello M, Maher L, Dore GJ; LiveRLife Study Group. Hepatitis C virus testing, liver disease assessment and treatment uptake among people who inject drugs pre- and post-universal access to direct-acting antiviral treatment in Australia: The LiveRLife study. J Viral Hepat. 2020 Mar;27(3):281-293. doi: 10.1111/jvh.13233. Epub 2019 Dec 6.

  PMID: 31698545 BACKGROUND

• Chevaliez S. Strategies for the improvement of HCV testing and diagnosis. Expert Rev Anti Infect Ther. 2019 May;17(5):341-347. doi: 10.1080/14787210.2019.1604221. Epub 2019 Apr 22.

  PMID: 30950298 BACKGROUND

• Smookler D, Vanderhoff A, Biondi MJ, Valencia J, Ryan P, Karkada J, Hong R, Sattar I, Mandel E, Gjevori M, Casey J, Fletcher D, Shah H, Hansen BE, Capraru C, Janssen HLA, Lazarus JV, Feld JJ. Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1451-1458.e4. doi: 10.1016/j.cgh.2020.07.058. Epub 2020 Aug 4.

  PMID: 32763480 BACKGROUND

• Debette-Gratien M, Francois S, Chevalier C, Alain S, Carrier P, Rigaud C, Abraham B, Burgevin AL, Courat L, Debenes B, Koffi J, Caux-Nussbaum E, Zattoni-Leroy J, Feuillet-Sow G, Dumont Q, Nubukpo P, Loustaud-Ratti V. Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days. J Viral Hepat. 2023 Apr;30(4):355-361. doi: 10.1111/jvh.13798. Epub 2023 Jan 11.

  PMID: 36597183 DERIVED

MeSH Terms

Conditions

Hepatitis C; Alcoholism; Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Marilyne DEBETTE-GRATIEN, MD

  Hôpital Dupuytren

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyne DEBETTE-GRATIEN, MD

CONTACT

33 5 55 05 87 26; MARILYNE.GRATIEN@chu-limoges.fr

Véronique LOUSTAUD-RATTI, Prof

CONTACT

33 5 55 05 66 84; veronique.loustaud-ratti@unilim.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: May 24, 2017
• Primary Completion: December 9, 2022
• Study Completion (Estimated): February 14, 2030
• Last Updated: May 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)