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Pharmacist-led Hepatitis C Management (PHARM-C)

2022年4月19日 更新者:University Health Network, Toronto

Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community

Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade. Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use. Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap. Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care. Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings. While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight. If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues. The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.

研究概览

研究类型

介入性

注册 (预期的)

108

阶段

  • 第四阶段

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。

学习联系方式

研究联系人备份

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M4Y 1G7
        • 招聘中
        • Specialty Rx Solutions
        • 接触:
        • 接触:

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

18年 至 80年 (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:

  1. HCV infection
  2. HCV RNA > 1,000 IU/mL
  3. Aged 18 to 80
  4. Willingness and capacity to provide informed consent

Exclusion Criteria:

  1. Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
  2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
  3. History of current or past hepatocellular carcinoma
  4. Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
  5. Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
  6. Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
  7. Significant co-morbid illness that precludes inclusion in the opinion of the investigator
  8. Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
  9. Pregnancy/breast-feeding/inability to use contraception
  10. Use of concomitant contraindicated drugs

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 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:Community Pharmacist-Led
Patients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight.
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
有源比较器:Academic hepatology
Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology

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
Intention to treat by Completion Rates
大体时间:24 months
Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).
24 months

次要结果测量

结果测量
措施说明
大体时间
Sustained Virologic Response by Intention-to-Treat
大体时间:24 months
Compare Sustained Virologic Response rates by Intention to treat in both sites.
24 months
Sustained Virologic Response by modified Intention-to-Treat
大体时间:24 months
Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)
24 months
Sustained Virologic Response by Per Protocol analysis
大体时间:24 months
Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.
24 months
Hepatitis C Community seroprevalence in downtown Toronto
大体时间:18 months
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
18 months
Community Pharmacist Fibrosis Identification
大体时间:18 months
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
18 months
Community Pharmacist Decompensation Identification
大体时间:18 months
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
18 months
Minimum Mean Time-to-Treatment
大体时间:18 months
Determine the minimum mean time-to-treatment initiation in both groups
18 months
Community Appointment Adherence
大体时间:24 months
Assess appointment adherence in both arms
24 months
Medication Adherence
大体时间:18 months
Assess self-reported medication adherence at both sites
18 months
Quality of Life and Substance Use
大体时间:24 months
Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.
24 months
Substance Use
大体时间:24 months
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
24 months
Patient Understanding and Satisfaction
大体时间:24 months
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
24 months
Reinfection
大体时间:24 months
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
24 months
Patient empowerment
大体时间:24 months
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
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。

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)

2022年4月13日

初级完成 (预期的)

2023年6月1日

研究完成 (预期的)

2023年12月1日

研究注册日期

首次提交

2020年2月20日

首先提交符合 QC 标准的

2020年3月24日

首次发布 (实际的)

2020年3月26日

研究记录更新

最后更新发布 (实际的)

2022年4月27日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2021年12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)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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