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

Autor: Håvard Midgard, Kjell Arne Johansson, Christian Ohldieck, Lars Thore Fadnes, Rafael Alexander Mo Leiva, Fatemeh Chalabianloo, Peter Vickerman, Olav Dalgard, Svetlana Skurtveit, Jørn Henrik Vold, Else-Marie Løberg, Christer Frode Aas, Ole Jørgen Scheie Lygren
Rok vydání: 2019
Předmět:
Counseling
Male
Sustained Virologic Response
Cost-Benefit Analysis
Aftercare
Hepacivirus
Chronic hepatitis C
Polymerase Chain Reaction
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Recurrence
Outpatient clinic
030212 general & internal medicine
Substance Abuse
Intravenous
Antiviral Agents/therapeutic use
Delivery of Health Care
Integrated
Norway
Standard treatment
Hepatitis C
Infectious Diseases
030211 gastroenterology & hepatology
Female
medicine.medical_specialty
Referral
Integrated health care
Hepacivirus/genetics
Antiviral Agents
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Hepatitis C/drug therapy
Pharmacotherapy
Delivery of Health Care
Integrated/methods
medicine
Opiate Substitution Treatment
Humans
lcsh:RC109-216
Intensive care medicine
Substance Abuse
Intravenous/complications
Hepatitis
business.industry
medicine.disease
Clinical trial
Treatment Adherence and Compliance
Substance abuse treatment centres
Quality of Life
business
Zdroj: BMC Infectious Diseases
Lim, A G 2019, ' Integrated treatment of hepatitis C virus infection among people who inject drugs : study protocol for a randomised controlled trial (INTRO-HCV) ', BMC Infectious Diseases, vol. 19, no. 1, pp. 943 . https://doi.org/10.1186/s12879-019-4598-7
BMC Infectious Diseases, Vol 19, Iss 1, Pp 1-9 (2019)
19:943
ISSN: 1471-2334
DOI: 10.1186/s12879-019-4598-7
Popis: 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: OpenAIRE
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