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The Copenhagen test and treat hepatitis C in a mobile clinic study: a protocol for an intervention study to enhance the HCV cascade of care for people who inject drugs (T’N’T HepC)
  1. Jeffrey Victor Lazarus1,
  2. Anne Øvrehus2,
  3. Jonas Demant3,
  4. Louise Krohn-Dehli4,
  5. Nina Weis4,5
  1. 1Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain
  2. 2Department of Infectious Diseases, Odense University Hospital, Odense, Denmark
  3. 3Users Academy, Copenhagen, Denmark
  4. 4Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark
  5. 5Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Jeffrey Victor Lazarus; jeffrey.lazarus{at}isglobal.org

Abstract

Introduction Injecting drug use is the primary driver of hepatitis C virus (HCV) infection in Europe. Despite the need for more engagement with care, people who inject drugs (PWID) are hard to reach with HCV testing and treatment. We initiated a study to evaluate the efficacy for testing and linkage to care among PWID consulting peer-based testing at a mobile clinic in Copenhagen, Denmark.

Methods and analysis In this intervention study, we will recruit participants at a single community-based, peer-run mobile clinic. In a single visit, we will first offer participants a point-of-care HCV antibody test, and if they test positive, then they will receive an HCV RNA test. If they are HCV-RNA+, we will administer facilitated referrals to designated ‘fast-track’ clinics at a hospital or an addiction centre for treatment. The primary outcomes for this study are the number of tested and treated individuals. Secondary outcomes include individuals lost at each step in the care cascade.

Ethics and dissemination The results of this study could provide a model for targeting PWID for HCV testing and treatment in Demark and other settings, which could help achieve WHO HCV elimination targets. The Health Research Ethics Committee of Denmark and the Danish Data Protection Agency confirmed (December 2018/January 2019) that this study did not require their approval. Study findings will be disseminated through peer-reviewed publications, conference presentations and social media.

  • Hepatology
  • Public health
  • Infectious diseases
  • Viral hepatitis
  • People who inject drugs
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @JVLazarus

  • Contributors JVL and JD conceived of the study. JVL and AØ drafted this protocol with input from NW, JD and LK-D. All authors reviewed subsequent versions and approved the final protocol for submission to the international review board.

  • Funding The mobile clinic is supported by the Danish Helsefonden (Health-Fund) and Sundhedsstyrelsen (Danish Health Authority). This study was supported by AbbVie (grant number SA-02643), Gilead Science (grant number 220001768) and MSD (financial educational grant signed 5/7/2019). JVL is supported by a Spanish Ministry of Science, Innovation and Universities Miguel Servet grant (Instituto de Salud Carlos III/ESF, European Union [CP18/00074]) and further acknowledges support from the Spanish Ministry of Science, Innovation and Universities to ISGlobal through the “Centro de Excelencia Severo Ochoa 2019-2023” Programme (CEX2018-000806-S), and from the Government of Catalonia through the CERCA Programme."

  • Competing interests JVL reports grants, personal fees and other from AbbVie and Gilead Sciences, personal fees from CEPHEID, GSK, Intercept and Janssen, and grants and personal fees from MSD, outside the submitted work. AØ reports grants, personal fees and other from AbbVie, Gilead Sciences and MSD, outside the submitted work. JD reports grants from AbbVie, Gilead Sciences and MSD, outside the submitted work. LK-D has nothing to disclose. NW reports unrestricted grants and personal fees from AbbVie and Gilead Sciences, grants and personal fees from MSD and grants from Bristol Myers Squibb, outside the submitted work.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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