NCT04809246已完成不适用
Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
研究概览
简要总结
A prospective historically controlled study to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, fast-tracked direct-acting antiviral (DAA) prescription, and linkage to hepatitis care (a 'one-stop-shop' intervention), on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •has provided written, informed consent to participate;
- •is male and ≥18 years of age on enrolment;
- •has been incarcerated within the last six weeks;
- •is HCV DAA treatment naïve;
- •is able and willing to provide informed consent and abide by the requirements of the study.
- •For HCV RNA positive participants commencing treatment:
- •if HIV-1 infected must also meet the following criteria:
- •HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load; and
- •be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the selected DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/ )
排除标准
- •For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
- •untreated HIV co-infection;
- •chronic HBV co-infection;
- •any clinically significant condition, history or concomitant medication known to contraindicate DAA therapy or would not be suitable for management within a prison-based treatment setting;
- •is unable to gain an accurate reading on the fibroscan or the result is invalid;
- •known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).
研究组 & 干预措施
Standard of care
No Intervention
The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care.
'One-stop-shop' intervention
Experimental
Following the control period, the second group (n=300) of participants enrolled in the study will be assigned to the intervention period to receive the 'one-stop-shop' intervention.
干预措施: 'One-stop-shop' hepatitis clinic (Other)
结局指标
主要结局
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
时间窗: 12 weeks from enrolment
次要结局
- The proportion of people who have an end of treatment response(End of Treatment (8 weeks from treatment initiation))
- The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)(Varying, up to end of subject enrolment (estimated to be 12 months from study commencement))
- The proportion of people reinfected at SVR12(Varying, up to 9 months post-enrolment.)
- The proportion of people lost to follow-up(Varying, up to end of study (estimated to be 12 months from study commencement))
- The proportion of participants who complete DAA therapy in prison(End of Treatment (8 weeks from treatment initiation))
- The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)(End of study (estimated to be 12 months from study commencement))
- The proportion of people tested for HCV infection at 12 weeks from enrolment(12 weeks from enrolment)
- The proportion of people who have an HCV treatment response (sustained virological response)(Sustained virological response at 12 weeks post treatment completion)
- The time taken from testing to each step in the care cascade(Varying, up to 9 months post-enrolment.)
- The proportion of people reporting injecting risk behaviours (at ETR and SVR12)(Varying, up to 9 months post-enrolment.)
研究者
研究点 (1)
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