REACH HCV

• Research type

  Research Study

• Full title

  Reaching methadone users attending community pharmacies with HCV

• IRAS ID

  258349

• Contact name

  John F Dillon

• Contact email

  j.f.dillon@dundee.ac.uk

• Clinicaltrials.gov Identifier

  NCT03935906

• Duration of Study in the UK

  2 years, 6 months, 1 days

• Research summary

  Research Summary
  40 community pharmacies in Scotland, Wales and Australia will be randomised to one of two intervention pathways to determine the best method of offering hepatitis C (HCV) testing and treatment to a patient group at risk of contracting HCV, namely patients who receive opiate substitution therapy (OST), following previous injecting drug use, at a community pharmacy.
  One group of pharmacies will provide their OST patients with educational materials on HCV testing and treatment and will direct them to their nearest testing and treatment centre.
  The second group of pharmacies will be visited by an outreach nurse who will administer point of care (POC) testing, take confirmatory and safety bloods and, where necessary, prescribe direct acting antiviral (DAA) therapy.
  In both arms the participant's community pharmacy will administer the DAA therapy in line with the patient's current OST regimen.
  The primary outcome of the study will be the number and proportion of participants in each arm who achieve a sustained viral response 12 weeks after end of treatment (SVR12). The group with the higher number/proportion of patients who achieve SVR12 will be deemed the most successful.
  Both groups will be analysed for cost effectiveness and acceptability to the patients by asking the participants to complete a short questionnaire, within the study CRF, and EQ5D-5L.

  Summary of Results
  Regular healthcare models struggle to engage those most at risk of hepatitis c. We trialled a new nurse-led pathway which offered point-of-care testing for hepatitis c in community pharmacies and compared clinical outcomes for this group to participants who received conventional care. Those who participated in the new pathway were more likely to receive a hepatitis c test; start treatment, if they were positive; complete that treatment; and obtain a cure. The new pathway made hepatitis c care more accessible.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  19/ES/0025

• Date of REC Opinion

  29 Mar 2019

• REC opinion

  Further Information Favourable Opinion