SuperDOT-C

  • Research type

    Research Study

  • Full title

    A cluster randomised trial of pharmacy led HCV therapy versus conventional treatment pathways for HCV positive patients receiving daily OST in pharmacies in Health Boards within NHS Scotland.

  • IRAS ID

    202859

  • Contact name

    John/F Dillon

  • Contact email

    j.f.dillon@dundee.ac.uk

  • Sponsor organisation

    University of Dundee

  • Clinicaltrials.gov Identifier

    NCT02706223

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers.
    The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff.
    Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy.
    The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.

  • REC name

    East of Scotland Research Ethics Service REC 1

  • REC reference

    16/ES/0055

  • Date of REC Opinion

    27 May 2016

  • REC opinion

    Further Information Favourable Opinion