Testing and Treating Hepatitis C in Community Pharmacies (SuperDOT-C)

August 29, 2019 updated by: University of Dundee

A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SuperDOT-C study will evaluate a new pathway of care for patients on OST who are already receiving OST therapy on a daily basis from a pharmacist. Newer therapies for HCV have recently become much simpler to initiate and supervise with much improved effectiveness and as described below it is now proposed to extend the role of community pharmacists into initiating HCV therapy alongside the existing OST The SuperDOT-C study will utilise this existing environment and relationship to smooth the pathway into HCV therapy with co-administration of OST alongside the anti-HCV therapy under the supervision of the pharmacist compared with the established pathway of referral to another site and treatment with a nurse led ant-HCV treatment program. This new pathway may have positive effects on the movement towards HCV cure at multiple levels. The planned pathway is different to current care at each point, from testing and diagnosis through adherence to cure. In the planned pathway, the patient interacts with the pharmacist on a daily basis, as compared to intermittent interaction with a secondary care team member. The result being that the patient has a shorter care pathway, with less travelling and better access to anti-HCV treatment. The daily interaction with the pharmacy provides opportunities to assess and support the patient, provide sound advice and care, with the added benefit of being able to directly observe treatment, (DOT), thus potentially improving adherence.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • NHS Grampian
      • Dundee, United Kingdom, DD1 9SY
        • NHS Tayside
      • Glasgow, United Kingdom, G$ 0SF
        • NHS Greater Glasgow and Clyde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist Led
This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists
Other: Pharmacist Led
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
Experimental: Nurse Led
This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses
Other: Nurse led
Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 week SVR, (12 weeks post completion of HCV treatment)
Blood test result; PCR - based measurement of levels of hepatitis C virus.
12 week SVR, (12 weeks post completion of HCV treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
Time Frame: Span of study ie 24 months
Health economics analysis
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
Time Frame: Span of study ie 24 months
Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway
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
Time Frame: Span of study ie 24 months
Comparison of compliance rates of antiviral medications between pharmacist and 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
Time Frame: Span of study ie 24 months
Compare the acceptability of the pharmacist pathway as compare to conventional pathway of care
Span of study ie 24 months
To measure re-infection rate at 1 year after end of treatment in patients with SVR
Time Frame: Span of study ie 24 months
Comparison of the rate of reinfections with HCV between pharmacist and conventional pathways
Span of study ie 24 months
To compare the number of patients who drop out of the study between the two pathways
Time Frame: Span of study ie 24 months
Comparison of subject drop out rates between pharmacist and conventional pathways
Span of study ie 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: John F Dillon, MD, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014GA07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Pharmacist Led

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe