A Five Year Plan of Enhanced HCV Monitoring, Primary Care-Based Workforce Development, Rapid Scale-up of HCV Treatment and Public Health Policy Action in HIV Positive Individuals Within Australia.
试验速览
- 阶段
- 不适用
- 入组人数
- 492
- 试验地点
- 18
- 主要终点
- HCV viraemia
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis C (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact on the proportion of people with HCV within the HIV-HCV coinfected population of Australia.
It is hypothesised that a rapid scale-up of hepatitis C treatment with interferon-free therapies in individuals with HIV-HCV coinfection will assist in controlling HCV infection in this population.
详细描述
This project has seven major components which will occur independently but are linked to the central theme of controlling and eliminating HCV infection from the majority of the Australian HIV positive population.
Database of HIV-HCV individuals (CEASE-D):
Surveillance of HIV-HCV positive individuals will occur through the enrolment into the CEASE-D observational study database. The proportion with HCV viraemia in this population will be determined through three cross-sectional surveys; at enrolment (2014-2016), follow-up 1 (2017-2018) and follow-up 2 (2019-2020). Participation will involve providing informed consent, collection of limited clinic and demographic information, a dried blood spot sample, patient completed CEASE questionnaires and FibroScan® (where available). It is estimated that approximately 1000 HIV-HCV coinfected individuals will be enrolled into the CEASE-D database.
Modelling (CEASE-M):
Mathematical modeling will be undertaken to examine various treatment strategies, including HCV treatment scale-up timelines. The data from the first cross-sectional survey of the HCV surveillance phase (CEASE-D) will inform components of the modeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •18 years of age or older
- •Voluntarily signed the informed consent form
- •HIV positive
- •HCV antibody positive
- •Adequate English and mental health status to provide written informed consent and comply with study procedures
- •CEASE-T (ISTEP):
- •18 years of age or older
- •Voluntarily signed the informed consent form
- •HIV positive
- •HCV RNA positive
- •Adequate English and mental health status to provide written informed consent and comply with study procedures
- •Undergoing DAA therapy HCV treatment.
- •18 years of age or older
- •Voluntarily signed the informed consent form
- •HIV positive
- •Undergone IFN-free DAA therapy for HCV
- •On treatment virological failure or post-treatment recurrent viraemia as defined by either:
- •Non-response: Failure of viral suppression on IFN-free DAA therapy
- •Virological breakthrough on IFN-free DAA therapy
- •Post-treatment recurrent viraemia: Detectable HCV RNA post-treatment following an end-of-treatment response (ETR, undetectable HCV RNA at end of treatment)
- •DBS Sub-study Population:
- •18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV positive 4) HCV antibody positive 5) Adequate English and mental health status to provide written informed consent and comply with study procedures 6) Under follow-up within I-STEP post-treatment for HCV
- •DBS Sub-study Controls:
- •18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV negative 4) HCV antibody positive 5) Undergoing DAA therapy for HCV and requiring confirmation of SVR post therapy 6) Adequate English and mental health status to provide written informed consent and comply with study procedures
- •18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV positive 4) HCV antibody positive 5) Adequate English and mental health status to provide written informed consent and comply with study procedures 6) Under follow-up within I-STEP post-treatment for HCV
排除标准
- •Inability or willingness to comply with protocol requirements
- •Inability or willingness to comply with protocol requirements
- •Inability or willingness to comply with protocol requirements
- •DBS Sub-study:
- •Inability or willingness to comply with protocol requirements
- •Inability or willingness to comply with protocol requirements
结局指标
主要结局
HCV viraemia
时间窗: 5 years
Proportion of HCV viraemia within the Australian HIV-HCV population over a five year period
次要结局
- Needs, behaviour and attitudes towards HCV treatment(5 years)
- HCV treatment response rates(5 years)
- Factors associated with HCV treatment and retreatment(5 years)
- HCV treatment uptake(5 years)
- Rates of HCV retreatment(5 years)
- HCV transmission history(5 years)