Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV).

Autor: Fadnes LT; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway. lars.fadnes@uib.no.; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. lars.fadnes@uib.no., Aas CF; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Vold JH; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Ohldieck C; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway., Leiva RA; Department of Medicine, Haukeland University Hospital, Bergen, Norway., Chalabianloo F; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Skurtveit S; Norwegian Centre for Addiction Research, University of Oslo, Oslo, Norway.; Department of Mental Disorders, Norwegian Institute of Public Health, Oslo, Norway., Lygren OJ; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; ProLAR Nett, Oslo, Norway., Dalgård O; Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway.; Institute for Clinical Medicine, University of Oslo, Oslo, Norway., Vickerman P; University of Bristol, Bristol, UK., Midgard H; Department of Gastroenterology, Oslo University Hospital, Oslo, Norway., Løberg EM; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; Department of Clinical Psychology Medicine, University of Bergen, Bergen, Norway.; Division of Psychiatry, Haukeland University Hospital, Bergen, Norway., Johansson KA; Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2019 Nov 08; Vol. 19 (1), pp. 943. Date of Electronic Publication: 2019 Nov 08.
DOI: 10.1186/s12879-019-4598-7
Abstrakt: Background: A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial.
Methods: INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID.
Discussion: This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up.
Trial Registration: ClinicalTrials.gov.no. NCT03155906.
Databáze: MEDLINE
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