Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Intention to treat by Completion Rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV infection
- •HCV RNA > 1,000 IU/mL
- •Aged 18 to 80
- •Willingness and capacity to provide informed consent
排除标准
- •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.
- •Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
- •History of current or past hepatocellular carcinoma
- •Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
- •Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
- •Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
- •Significant co-morbid illness that precludes inclusion in the opinion of the investigator
- •Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
- •Pregnancy/breast-feeding/inability to use contraception
- •Use of concomitant contraindicated drugs
结局指标
主要结局
Intention to treat by Completion Rates
时间窗: 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).
次要结局
- Sustained Virologic Response by modified Intention-to-Treat(24 months)
- Hepatitis C Community seroprevalence in downtown Toronto(18 months)
- Community Pharmacist Decompensation Identification(18 months)
- Quality of Life and Substance Use(24 months)
- Patient Understanding and Satisfaction(24 months)
- Sustained Virologic Response by Intention-to-Treat(24 months)
- Sustained Virologic Response by Per Protocol analysis(24 months)
- Community Pharmacist Fibrosis Identification(18 months)
- Community Appointment Adherence(24 months)
- Medication Adherence(18 months)
- Substance Use(24 months)
- Minimum Mean Time-to-Treatment(18 months)
- Reinfection(24 months)
- Patient empowerment(24 months)