- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02706223
Testing and Treating Hepatitis C in Community Pharmacies (SuperDOT-C)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Aberdeen, Reino Unido, AB25 2ZN
- NHS Grampian
-
Dundee, Reino Unido, DD1 9SY
- NHS Tayside
-
Glasgow, Reino Unido, G$ 0SF
- NHS Greater Glasgow and Clyde
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Pharmacist Led
This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists
|
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
|
Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Span of study ie 24 months
|
Comparison of subject drop out rates between pharmacist and conventional pathways
|
Span of study ie 24 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John F Dillon, MD, University of Dundee
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2014GA07
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .