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

29 augusti 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

356

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Span of study ie 24 months
Comparison of subject drop out rates between pharmacist and conventional pathways
Span of study ie 24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Dundee

Utredare

  • Huvudutredare: John F Dillon, MD, University of Dundee

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2016

Primärt slutförande (Faktisk)

1 januari 2019

Avslutad studie (Faktisk)

1 mars 2019

Studieregistreringsdatum

Först inskickad

4 mars 2016

Först inskickad som uppfyllde QC-kriterierna

9 mars 2016

Första postat (Uppskatta)

11 mars 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2014GA07

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

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