NCT02706223

Brief Summary

Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers. The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff. Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy. The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

March 4, 2016

Last Update Submit

August 29, 2019

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy

    Blood test result; PCR - based measurement of levels of hepatitis C virus.

    12 week SVR, (12 weeks post completion of HCV treatment)

Secondary Outcomes (6)

  • Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway

    Span of study ie 24 months

  • To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment

    Span of study ie 24 months

  • To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway

    Span of study ie 24 months

  • To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients

    Span of study ie 24 months

  • To measure re-infection rate at 1 year after end of treatment in patients with SVR

    Span of study ie 24 months

  • +1 more secondary outcomes

Study Arms (2)

Pharmacist Led

EXPERIMENTAL

This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists

Other: Pharmacist Led

Nurse Led

EXPERIMENTAL

This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses

Other: Nurse led

Interventions

Pharmacist LedOTHER

Trial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects

Pharmacist Led
Nurse ledOTHER

Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses

Nurse Led

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HCV PCR positive,
  • Stable OST dose for greater than 12 weeks prior to study enrolment

You may not qualify if:

  • Evidence of current or previous decompensated liver disease,
  • Currently receiving HCV eradication treatment
  • HIV infection,
  • HBsAg positive with detectable HBV DNA,
  • Pregnancy
  • Cirrhosis or high fibrosis score
  • Genotype deemed unsuitable for treatment with available study drugs
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G$ 0SF, United Kingdom

Location

Related Publications (3)

  • Radley A, de Bruin M, Inglis SK, Donnan PT, Hapca A, Barclay ST, Fraser A, Dillon JF. Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):809-818. doi: 10.1016/S2468-1253(20)30120-5. Epub 2020 Jun 8.

    PMID: 32526210DERIVED

  • Hickman M, Dillon JF, Elliott L, De Angelis D, Vickerman P, Foster G, Donnan P, Eriksen A, Flowers P, Goldberg D, Hollingworth W, Ijaz S, Liddell D, Mandal S, Martin N, Beer LJZ, Drysdale K, Fraser H, Glass R, Graham L, Gunson RN, Hamilton E, Harris H, Harris M, Harris R, Heinsbroek E, Hope V, Horwood J, Inglis SK, Innes H, Lane A, Meadows J, McAuley A, Metcalfe C, Migchelsen S, Murray A, Myring G, Palmateer NE, Presanis A, Radley A, Ramsay M, Samartsidis P, Simmons R, Sinka K, Vojt G, Ward Z, Whiteley D, Yeung A, Hutchinson SJ. Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol). BMJ Open. 2019 Sep 24;9(9):e029538. doi: 10.1136/bmjopen-2019-029538.

    PMID: 31551376DERIVED

  • Radley A, de Bruin M, Inglis SK, Donnan PT, Dillon JF. Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy: a study protocol for a pragmatic cluster randomised trial. BMJ Open. 2018 Dec 14;8(12):e021443. doi: 10.1136/bmjopen-2017-021443.

    PMID: 30552244DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Practice Patterns, Nurses'

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • John F Dillon, MD

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 11, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

GB(3)