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

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ClinicalTrials.gov Identifier: NCT02706223
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Dundee

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatitis C Other: Pharmacist Led Other: Nurse led Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway [ Time Frame: Span of study ie 24 months ]
    Health economics analysis

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706223


Locations
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United Kingdom
NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
NHS Tayside
Dundee, United Kingdom, DD1 9SY
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G$ 0SF
Sponsors and Collaborators
University of Dundee
Investigators
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Principal Investigator: John F Dillon, MD University of Dundee
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT02706223    
Other Study ID Numbers: 2014GA07
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections