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

2019年8月29日 更新者: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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

356

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
实验性的: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Span of study ie 24 months
Comparison of subject drop out rates between pharmacist and conventional pathways
Span of study ie 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:John F Dillon, MD、University of Dundee

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月1日

初级完成 (实际的)

2019年1月1日

研究完成 (实际的)

2019年3月1日

研究注册日期

首次提交

2016年3月4日

首先提交符合 QC 标准的

2016年3月9日

首次发布 (估计)

2016年3月11日

研究记录更新

最后更新发布 (实际的)

2019年8月30日

上次提交的符合 QC 标准的更新

2019年8月29日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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