A Multi-centre, Practice-level, Cluster Randomized Controlled Trial to Compare Point-of-care HCV RNA Testing, Dried Blood Spot Testing, and Standard of Care to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,801
- 试验地点
- 34
- 主要终点
- Proportion of HCV RNA positive who initiate HCV treatment
研究概览
简要总结
This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis:
- HCV testing from collected dried blood spots sent to a central laboratory
- HCV testing using a point-of-care device at the NSP site
- HCV testing using standard of care at the NSP site
详细描述
The TEMPO study will compare dried blood spot testing and point-of-care HCV RNA testing to standard of care as strategies to enhance HCV treatment uptake among people with HCV and recent injecting drug use attending NSP services. Peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study.
The study is a cluster randomized controlled trial. The sites (clusters) will be primary NSPs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia.
Eighteen NSPs (the clusters) will be randomly allocated to receive point-of-care HCV RNA testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters).
At screening, participants will be tested for HCV infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation.
Screening will continue until a total of 150 HCV RNA positive participants (~25 participants per site) are enrolled in the dried blood spot arm, 150 HCV RNA positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. Hence a total of 450 HCV RNA positive participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •for participants:
- •Attendees of the NSP service are eligible for inclusion if the following criteria are met:
- •Provided written informed consent
- •≥ 18 years of age
- •Recent injecting drug use - defined as self-reported use within the previous six months.
排除标准
- •for participants:
- •a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
研究组 & 干预措施
Point-of-care RNA (Intervention)
Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
干预措施: Xpert HCV Viral Load Fingerstick (Diagnostic Test)
Dried Blood Spot (Intervention)
Blood samples will be tested for HCV RNA from dried blood spot cards.
干预措施: Aptima HCV Quant DX Assay (Diagnostic Test)
Standard of Care (Control)
Sites will continue with their standard of care for hepatitis C testing.
结局指标
主要结局
Proportion of HCV RNA positive who initiate HCV treatment
时间窗: 12 weeks from Enrolment
To compare the proportion of HCV RNA positive participants who initiate HCV treatment at 12 weeks following enrolment between those who receive point-of-care HCV RNA testing, dried blood spot testing, and standard of care.
次要结局
未报告次要终点