Methods and AnalysisWe plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle & syringe programmes (NSPs), pharmacies, and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over two years from 2017/18, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative (NESI) survey in Scotland and the Unlinked Anonymous Monitoring Programme (UAM) in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (also called Causal Inference Models) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale up in HCV treatment to observed changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a “virtual cohort” of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes.
Ethics and DisseminationExtending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683,Super DOT C Trial clinicaltrials.gov:NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (INSERT) and ISCRCTN registration has been completed (INSERT). Our findings will have direct NHS and patient relevance; informing prioritization given to early HCV treatment for PWID. We will present findings to practitioners and policy makers, and support design of an evaluation of HCV TasP in England.
- BTC (Bristol Trials Centre)
- Centre for Surgical Research