Article Text
Abstract
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; are not co-infected with HIV and/or hepatitis B; have no decompensated liver disease; are 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 in a pharmacy. Primary trial outcome is number of sustained virological responses 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. Caldicott guardian approval was given on 16 December 2016 to allow NHS Tayside to pass information to the cluster community pharmacies about the HCV test status of patients that they are seeing to provide OST supervision. NHS R&D approvals have been obtained from each health board taking part in the study. Informed consent is obtained before study enrolment and only anonymised data are stored in a secured database, enabling an audit trail. Results will be submitted to international peer-reviewed journals and presented at international conferences.
Trial registration number NCT02706223; Pre-results.
- hepatitis c
- clinical pathways
- community pharmacy
- randomised controlled trial
- direct-acting antivirals
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Footnotes
Contributors AR: study conception, planning and design, protocol preparation, manuscript preparation. MdB: conception, planning and design, protocol preparation manuscript preparation. JFD: study conception and design, protocol preparation, manuscript preparation. SKI: protocol preparation, planning and design, randomisation, study management, manuscript preparation. PTD: study conception, planning and design, statistical advice, protocol preparation, manuscript preparation.
Funding This study was funded in partnership by the Scottish Government, Gilead and Bristol-Myers Squib. The funders have no responsibilities for or authority over study design; collection, management, analysis or interpretation of data; writing of the report; and the decision to submit the report for publication.
Competing interests AR: honorariums from Gilead and Abbvie; Research Grants from Gilead and Roche. JFD: research grants and honorariums from Abbvie, Bristol Myers Squibb, Gilead, Janssen, Merck Roche Sharp & Dohme and Roche. PTD: research grants from Novo Nordisk, GSK, Shire Pharmaceuticals, Gilead and Bristol Myers Squibb; member of the New Drugs Committee of the Scottish Medicines Consortium. SKI and MdB: none.
Patient consent Not required.
Ethics approval Approval was received for this study (15/ES/0086) from East of Scotland Research Ethics Committee 2 on 27 May 2016.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Stephen Thomas Barclay, Andrew Fraser.