Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy:a study protocol for a pragmatic cluster randomised trial

Introduction: Hepatitis C Virus (HCV) infection affects 0.7% of the general population, and up to 40% of people prescribed Opioid Substitution Therapy (OST) in Scotland. In conventional care, less than 10% of OST users are tested for HCV and less than 25% of these initiate treatment. Community pharmacists see this group frequently to provide OST supervision. This study examines whether a pharmacist-led ‘test & treat’ pathway increases cure rates for HCV.Methods and Analysis: This protocol describes a cluster randomised trial where 60 community pharmacies provide either conventional or pharmacy-led care. All pharmacies offer dried blood spot testing (DBST) for HCV. Participants have attended the pharmacy for OST for 3 months; are positive for HCV genotype 1 or 3; not co-infected with HIV and/or hepatitis B; no decompensated liver disease; not pregnant. For conventional care, pharmacists refer HCV positive participants to a local centre for assessment. In the pharmacy-led arm, pharmacists assess participants themselves in the pharmacy. Drug prescribing is by nurse prescribers (conventional arm) or pharmacist prescribers (pharmacy-led arm). Treatment in both arms is delivered as daily modified directly observed therapy (DOT) in a pharmacy. Primary trial outcome is number of sustained viral responses (SVR) at 12 weeks after treatment completion. Secondary trial outcomes are number of tests taken; treatment uptake; completion; adherence; re-infection. An economic evaluation will assess potential cost-effectiveness. Qualitative research interviews with clients and health professionals assess acceptability of a pharmacist-led pathway.Ethics and Dissemination: This protocol has been ethically approved by the East of Scotland Research Ethics Committee 2 (15/ES/0086) and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Informed consent is obtained before study enrolment and only anonymised data is stored in a secured database, enabling an audit trail. Results will be submitted to international peer-reviewed journals and presented at international conferences.ClinicalTrials.gov Identifier: NCT0270622