Eliminate Hepatitis C/EC Partnership Evaluation Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Uptake of treatment amongst PWID
研究概览
简要总结
The Eliminate Hepatitis C (EC) Partnership project is a multi-site, multi-year project aiming to enhance and extend hepatitis C virus (HCV) care and treatment among people who inject drugs (PWID) through nurse-led models of care in the community and the prison system. The project will implement and evaluate a health service intervention to enhance HCV response by improving health promotion, offering training and education to service providers, streamlining clinical pathways, utilising data systems and surveillance and implementing the results of ongoing research and evaluation.
Health services data will be used to assess the impact of the EC nurse-led support, to enhance the clinical pathway and increase HCV testing, linkage to care and treatment uptake in community and prison settings. This will include provider and client interviews and a sentinel surveillance system (ACCESS) that will track and monitor impact indicators including HCV testing, linkage to care and treatment uptake at the service and population level.
Overall, evaluation data will be used to monitor the uptake of HCV treatment in PWID, monitor the effectiveness of community- and prison-based treatment program and assess the cost and feasibility of treating >1160 PWID in community-/prison-based program and assess changes in HCV prevalence in Victoria and modelling the impact of treating PWID to inform HCV elimination models in Australia and globally.
详细描述
An estimated 71 million people are living with hepatitis C virus (HCV) world-wide, at significant risk of morbidity and mortality from liver cirrhosis, liver failure and hepatocellular carcinoma. However, the development of well-tolerated, highly-efficacious curative direct-acting antiviral treatment (DAAs) has contributed to a global push to eliminate HCV as a public health threat. The World Health Organization has developed a global strategy for elimination that calls for 90% of people living with HCV to be diagnosed and 90% of those diagnosed to be treated by 2030.
In 2015, prior to the DAAs being released, it was estimated that around 230,000 people living with HCV in Australia. Like in many other high-income countries, the group most affected by HCV in Australia are people who inject drugs (PWID), making this a key population group for Australia's HCV elimination efforts.
Despite the availability of DAAs through Australia's Pharmaceutical Benefits Scheme (PBS), numerous barriers exist for PWID to access HCV care and particularly to accessing tertiary-based care. As such, targeting community-based services that provide comprehensive care packages for PWID, including the provision of opioid substitution therapy (OST), counselling, a needle and syringe program (NSP) for the delivery of HCV treatment should increase PWIDs' engagement in HCV care. The EC Partnership program has been funded to increase capacity of community and prison services to provide HCV testing and treatment with DAA treatments by streamlining clinical pathways and reducing barriers to access.
The EC Partnership project is a multi-site, multi-year project aiming to enhance and extend hepatitis C virus (HCV) care and treatment among people who inject drugs (PWID) through nurse-led models of care in the community and the prison system. Specifically the project aims to:
- Increase demand for HCV treatment among PWID;
- Increase the capacity of community services to provide HCV testing & treatment with PBS listed DAAs;
- Increase the capacity to provide HCV testing & treatment in prison with PBS listed DAAs;
- Streamline clinical pathways (tailored for different types of settings) to increase access to PBS listed DAAs; and
- Establish an integrated HCV surveillance system to more accurately monitor trends in HCV prevalence and incidence over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The level of recruitment is clinics rather than individuals. Eligible clinics are those with a high HCV caseload, with a focus on drug and alcohol community clinics and general practitioners.
- •Eligibility criteria for individuals providing information in the form of interviews will be:
- •18 years of age or older; AND
- •Willing and able to provide informed, written consent to participate; AND
- •Either of:
- •staff of a participating EC site who are involved in hepatitis C care; OR
- •clients of a participating EC site who attend the site for screening and management of hepatitis C.
排除标准
- 未提供
结局指标
主要结局
Uptake of treatment amongst PWID
时间窗: 5 years
The number of PWID who commence HCV treatment across EC partnerships sites over time and compared to tertiary care models
次要结局
- Changes in HCV prevalence and incidence in Victoria(5 years)
- Treatment effectiveness relative to tertiary care services(5 years)
- Costs of scaling up treatment for PWID(5 years)
- Projected impact on HCV elimination targets(5 years)