Theme: Clinical Research Year: 2016
DOT-C: A PILOT TRIAL OF DIRECTLY OBSERVED ANTI HCV THERAPY IN A POPULATION RECEIVING OPIATE SUBSTITUTION THERAPY (OST) FROM A PHARMACY – UPTAKE OF TESTING RESULTS
Radley A1, Dillon J2.
1. Directorate of Public Health NHS Tayside.
2. University of Dundee Medical School
Background: Patients at high risk of Hepatitis C (HCV) infection should be offered HCV testing. Less than 10% of OST patients are tested for HCV and of these fewer than 20% enter treatment. Currently, test-positive patients are referred to nurse-led conventional care pathways delivered from secondary care. Pharmacists have daily interactions with OST patients in Primary Care. Utilising the capacity offered by pharmacy delivery of treatment, may support eradication strategies designed to clear all HCV infection from populations. This phase II study is designed to pilot systems to evaluate whether a pharmacist-led HCV treatment pathway increases the uptake of testing and treatment in OST patients compared to the conventional pathway.
Methods: DOT-C is a cluster randomised trial of directly observed anti HCV therapy in a pharmacy-led pathway versus conventional care, for HCV positive patients receiving pharmacist-delivered OST. Community pharmacies participating in the trial provide the 8 clusters. Each pharmacy is randomised to either the conventional NHS care pathway or pharmacist-led pathway. Patient entry into the trial is by reactive Dried Blood Spot Test (DBST) undertaken at the pharmacy attended for OST. Patients are either referred to the conventional pathway or assessed and treated in the pharmacy.
Results: During December 2015-February 2016, 159 DBST were taken from 285 previously untested patients who used the 8 pharmacies. The DBSTs identified 18 new reactive tests which were referred through the conventional pathway and 29 new reactive tests for assessment through the pharmacist-led pathway. Across the cohort, 7% of patients known to have HCV were re-tested and 7% of patients who had been tested within 12 months were re-tested.
Conclusion: DOT-C has established a workable design and approach to enable the planned definitive phase III multicenter randomized controlled trial using a community pharmacy pathway to treat HCV in patients participating in an OST program.
Trial Registration: UKCRN ID 19636Download abstract Download poster