The Copenhagen Test and Treat Hepatitis C in a Mobile
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Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-039724 on 9 November 2020. Downloaded from 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) Jeffrey Victor Lazarus ,1 Anne Øvrehus,2 Jonas Demant,3 Louise Krohn- Dehli,4 Nina Weis 4,5 To cite: Lazarus JV, ABSTRACT Strengths and limitations of this study Øvrehus A, Demant J, et al. Introduction Injecting drug use is the primary driver of The Copenhagen test and hepatitis C virus (HCV) infection in Europe. Despite the ► This protocol presents one of the first studies glob- treat hepatitis C in a mobile need for more engagement with care, people who inject clinic study: a protocol for an ally to employ a peer-led integrated model of care, drugs (PWID) are hard to reach with HCV testing and intervention study to enhance with the latest point-of- care technology, to target treatment. We initiated a study to evaluate the efficacy for the HCV cascade of care people who inject drugs for hepatitis C testing, treat- testing and linkage to care among PWID consulting peer- for people who inject drugs ment and care outside of addiction treatment. (T’N’T HepC). based testing at a mobile clinic in Copenhagen, Denmark. BMJ Open ► The study will use both antibody rapid detection Methods and analysis In this intervention study, we will 2020;10:e039724. doi:10.1136/ tests and RNA point- of-care testing in order to sim- bmjopen-2020-039724 recruit participants at a single community- based, peer- run plify and expedite hepatitis C diagnosis. mobile clinic. In a single visit, we will first offer participants ► Prepublication history for ► This study’s point- of- care testing directly reaches a point- of- care HCV antibody test, and if they test positive, this paper is available online. marginalised populations, including people who in- then they will receive an HCV RNA test. If they are HCV- To view these files, please visit ject drugs, undocumented migrants and homeless RNA+, we will administer facilitated referrals to designated the journal online (http:// dx. doi. individuals, and involves close collaboration among ‘fast- track’ clinics at a hospital or an addiction centre org/ 10. 1136/ bmjopen- 2020- on- site nurses, community-based organisations and 039724). for treatment. The primary outcomes for this study are the infectious disease departments of two major http://bmjopen.bmj.com/ the number of tested and treated individuals. Secondary university hospitals in Copenhagen, Denmark. Received 23 April 2020 outcomes include individuals lost at each step in the care ► Since this study involves marginalised populations Revised 06 October 2020 cascade. Accepted 08 October 2020 that may be reluctant to continue care, there may Ethics and dissemination The results of this study could be potential loss to follow-up, which the implement- provide a model for targeting PWID for HCV testing and ing community- based organisation is working to treatment in Demark and other settings, which could help mitigate. achieve WHO HCV elimination targets. The Health Research Ethics Committee of Denmark and the Danish Data Protection Agency confirmed (December 2018/January fact, the estimated prevalence of HCV in on September 29, 2021 by guest. Protected copyright. 2019) that this study did not require their approval. Study PWID is 53.2% in Western Europe and 64.7% findings will be disseminated through peer- reviewed 5 publications, conference presentations and social media. in Eastern Europe. Moreover, researchers estimate that almost half of HCV infections among PWID in Europe are undiagnosed6 INTRODUCTION and that more than 90% of incident infec- Owing to the high efficacy and safety of tions in Europe are in PWID.7 direct- acting antivirals (DAAs), in 2016 the Despite the need for HCV testing and treat- © Author(s) (or their World Health Organization (WHO) estab- ment in PWID, this population is considered employer(s)) 2020. Re- use lished an ambitious goal to reduce the inci- hard to reach in both of these areas.8 Further- permitted under CC BY-NC. No commercial re- use. See rights dence of hepatitis C virus (HCV) by 80% and more, coverage of harm reduction services to and permissions. Published by to treat 80% of eligible persons with HCV by prevent HCV transmission among PWID is defi- BMJ. 2030.1–3 Targeting people who inject drugs cient in most settings worldwide.9 In Australia, For numbered affiliations see (PWID) is a practical approach to achieving where specific measures have been taken to end of article. this goal as unsafe injecting drug use is the ameliorate the cascade of care among PWID, Correspondence to main contributor to the spread of HCV in a 2017 study showed that 89% of PWID had Dr Jeffrey Victor Lazarus; Europe, with an increasing prevalence of HCV antibody testing, 57% of these were anti- jeffrey. lazarus@ isglobal. org HCV in PWID during the last decade.4 5 In body positive and, of these, 46% had received Lazarus JV, et al. BMJ Open 2020;10:e039724. doi:10.1136/bmjopen-2020-039724 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-039724 on 9 November 2020. Downloaded from confirmatory HCV RNA testing.10 Only 31% of PWID with a ‘point- of- care’ test where the person examined receives active infection or chronic infection that had been previ- the test result immediately after the test is completed and ously treated had received specialist HCV assessment, 8% not necessarily at a hospital or clinic. Although reflex had received antiviral treatment and 3% were cured.10 As testing (ie, conducting an Anti-HCV Ab test, and if this is such, reaching WHO goals among PWID requires substan- positive then conducting an HCV RNA test with the same tially strengthening the cascade of care from diagnosis to blood sample) is the norm in Copenhagen, for PWID post- treatment follow- up efforts and, especially, increasing most experts recommend administering both anti-HCV efforts to test, link, care and treat PWID.1–3 and HCV RNA tests and providing the responses during a A nationwide campaign for awareness and case finding single visit to avoid loss to follow-up between tests and/or of HCV was shown to be cost- effective among PWID in receiving test results.22 This strategy is feasible in various the Netherlands.11 This aligns with the ‘Find the Missing settings, including harm reduction centres and primary Millions’ campaign of the World Hepatitis Alliance, care and have been shown to be cost-effective in the which was launched in 2018 to diagnose individuals latter.23 24 Other interventions have been assessed with unknowingly living with viral hepatitis.12 Interventions to regard to their enhancement of linkage to care among enhance HCV testing include a wide range of measures PWID infected with HCV, with facilitated referral for such as on- site testing with pretest counselling and educa- HCV assessment and scheduling of specialist appoint- tion or dried blood spot testing, although they are largely ments among others.13 Fast- track clinics, condensing all in the preliminary phases of assessment.13 In the general necessary requirements for testing in a single visit to the practice setting, HCV testing among PWID is feasible prescriber, have proven efficient.25 Further, clinics dedi- but also has some drawbacks. For example, an Austra- cated to vulnerable populations are more sensitive to the lian study with 888 participants found that 93% of PWID stigma and lack of trust PWID might have faced in the attending general practitioners had an antibody test, but healthcare system previously.26 RNA testing was incomplete for more than one-third of DAAs have also proved effective and safe in real- world the antibody- positive individuals.14 studies, including for PWID, when provided through a Within Danish contexts, a regional study on PWID multidisciplinary model of care.27 28 Moreover, the para- connected to addiction services (1996–2015) found a digm is shifting to the use of HCV treatment to prevent prevalence of persons with positive anti- HCV antibodies the spread of the infection (ie, treatment as prevention), (Anti- HCV Ab+) of 64% and 33% for HCV RNA+ (ie, which a mathematical model has demonstrated as achiev- chronically infected).15 Before the DAA era in Denmark, able in Denmark.29 30 However, this is reliant on engaging approximately 20 000 persons had chronic HCV, an esti- many more PWID in care. In a recent nationwide Danish mated 500 persons were newly infected each year and, of study, ongoing substance use and non- adherence to these, 300 would develop chronic HCV.16 In 2015, the esti- medical appointments were the most frequent reasons 31 mated prevalence of people with HCV and active infec- for not starting HCV treatment with DAAs. http://bmjopen.bmj.com/ tion (ie, viraemic) was 0.3%17 and at the end of 2016 the Peer- based testing has been demonstrated to enhance population living with diagnosed chronic HCV was 7581 testing uptake, which can engage individuals who are people, of which the estimated undiagnosed fraction was not in contact with conventional HCV care for testing 24% and so the total diagnosed and undiagnosed number and treatment.13 Moreover, knowledge of HCV status has was estimated to be 9975, corresponding to 0.21% of the been proven to increase sterile syringe use among PWID, adult population.18 which further strengthens prevention approaches.32 As In the city of Copenhagen, drug treatment centres have such, it is expected that a simplified HCV care pathway been obliged to offer HCV testing for all PWID, following protocol with peer- based support services will reach indi- on September 29, 2021 by guest.