• Inglis, Sarah K.
• Donnan, Peter T.
• Dillon, John F.
• Bruin, Marijn De
• Radley, Andrew

Abstract

<b>Introduction</b>: 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 &amp; treat’ pathway increases cure rates for HCV.<br/><br/><b>Methods and Analysis</b>: 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.<br/><br/><b>Ethics and Dissemination</b>: 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.<br/><b><br/>ClinicalTrials.gov Identifier</b>: NCT02706223

Topics

• impedance spectroscopy
• cluster
• laser emission spectroscopy