Hepatitis C Clinical Trial
— SCANVIROfficial 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
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | February 14, 2030 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Limoges | Limoges | Haute Vienne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
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. — View Citation
Brouard C, Pillonel J, Boussac M, de Lédinghen V, Rachas A, Silvain C, Lydié 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. — View Citation
Brouard C, Saboni L, Gautier A, Chevaliez S, Rahib D, Richard JB, Barin F, Larsen C, Sommen C, Pillonel J, Delarocque-Astagneau E, Lydié 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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Tran A, Shili-Masmoudi S, Moga L, Chevaliez S, Luciani A, Ruiz I, Ganne-Carrié N, Bureau C, Bourlière M, de Lédinghen 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of days actually completed and the number of participants per session | 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® | up to 10 years | |
Secondary | Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist | Evaluate the acceptability of risk reduction methods as part of the care pathway. | up to 10 years | |
Secondary | Number of patients who had social care | Evaluate the impact of screening in terms of patient care. | up to 10 years | |
Secondary | Number of anti-viral B vaccinations offered and carried out | Evaluate the impact of screening in terms of patient care. | up to 10 years | |
Secondary | Number of GeneXperts performed compared to the number proposed | Evaluate the impact of screening in terms of patient care. | up to 10 years | |
Secondary | The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication | Evaluate the impact of screening in terms of patient care. | up to 10 years | |
Secondary | Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients, | Evaluate the impact of screening in terms of patient care. | up to 10 years | |
Secondary | The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients | Evaluate the impact of screening in terms of patient care. | up to 10 years |
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