HepCare: The Effectiveness of Community Based Interventions With Peer Support to Improve Case Detection, Carry Out Pre-treatment Assessments and Assist Underserved Populations Through HCV Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Successful engagement with community based HCV screening and treatment
研究概览
简要总结
Hepatitis C infection is a major cause of chronic liver disease and death with approximately 3% of the world's population is infected with hepatitis C virus (HCV).
New drug therapies called new direct-acting antivirals (DAAs) have been developed and have proven to be well tolerated with minimal side effects. The current costs of these agents are extremely high, however, they provide an opportunity to cure most patients of HCV if they can access and adhere to treatment. The bigger challenge is to engage and cure underserved groups who are not accessing medical care, or who have other complex problems, including homelessness, incarceration, and substance misuse problems.
Strategies to improve HCV case detection and case management have much to learn from other infectious diseases. Tuberculosis (TB) disproportionately affects in large part the same group of individuals and community models of care have been used with great success. Strategies such as active case finding, community based screening and treatment, directly observed therapy (DOT) and peer support have all shown high rates of case detection and treatment completion.
These strategies are currently being used by the Find&Treat team, UCLH NHS Trust and this study will ain in evaluating it's effectiveness. Previously used to aid homeless patients engage with treatment services for TB, it is now being used with other disease groups such as HCV.
This observational study aims to assess the effectiveness of community based interventions with peer support to improve case detection, carry out pre-treatment assessments and assist underserved populations through HCV treatment by the Find&Treat service.
详细描述
- Introduction
Hepatitis C infection is a major cause of chronic liver disease and death throughout the world1. Approximately 3% of the world's population is infected with hepatitis C virus (HCV)2.
HCV is transmitted by blood and in the UK occurs primarily through injecting drug use. Chronically infected people are at risk of progressive liver disease characterised by hepatocellular inflammation, hepatic fibrosis, cirrhosis and hepatocellular carcinoma (HCC). These complications develop only in a proportion of patients and only after many years or decades of infection3. It has been estimated that up to 20% of chronically infected individuals will develop cirrhosis of the liver over a 20 to 25 year period. Approximately 3% to 4% of patients with cirrhosis will develop HCC per year3.
New drug therapies such as protease and polymerase inhibitors called direct-acting antivirals (DAAs) have been developed in the last ten years and have recently been licensed for use worldwide. These DAAs have proven to be very well tolerated with minimal, and sometimes no, side effects. The current costs of these agents are extremely high, limiting their use to select populations of infected patients. However, they provide an opportunity to cure most patients with HCV if they can access and adhere to treatment. A bigger challenge is to engage and cure those who are not accessing medical care, or who have other complex problems, including homelessness, incarceration, and substance misuse. These underserved populations are disproportionately affected by infectious diseases such as HCV and face many challenges to access testing and adherence to treatment.
There has been previously demonstrated a high prevalence (13% RNA detectable HCV4) of chronic HCV infection among homeless people opportunistically screened at residential hostels and day centres across London. Data from the HALT Hepatitis Study5 showed that 41% of HCV Ab positive recruits were homeless at enrolment and that over 60% of HCV infected patients knew of their status but had disengaged from treatment services. This population therefore includes a high number of undiagnosed cases and previously known HCV positive cases who are not accessing treatment services.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 16 years of age
- •Underserved populations in the community. This is defined as groups whose social circumstances, language, culture or lifestyle make it difficult to access diagnostic and treatment services, self administer treatment or attend regular appointments for clinical follow up. This could include people who are homeless, people who misuse substances, prisoners, vulnerable migrants.
- •Willingness and ability to provide signed informed consent
- •The language ability to understand the PIS and other study information and therefore to able to provide informed consent
排除标准
- •Less 16 years of age
- •Unable to give informed consent
结局指标
主要结局
Successful engagement with community based HCV screening and treatment
时间窗: 18 months
Successful engagement with community based HCV screening and treatment is defined as: i. Successful pre-treatment assessment and a decision to not proceed by the clinician ii. Engagement with treatment support (including offered, start or completion of therapy according to individual circumstance)
次要结局
- Estimate the proportion of homeless people with chronic HCV infection and their degree of liver fibrosis.(18 months)
- Risk factors for HCV infection and for re-infection for those completing treatment or testing negative at recruitment.(18 months)
