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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kirby Institute
- Enrollment
- 1,801
- Locations
- 34
- Primary Endpoint
- Proportion of HCV RNA positive who initiate HCV treatment
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •for participants:
- •a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Arms & Interventions
Point-of-care RNA (Intervention)
Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
Intervention: Xpert HCV Viral Load Fingerstick (Diagnostic Test)
Dried Blood Spot (Intervention)
Blood samples will be tested for HCV RNA from dried blood spot cards.
Intervention: Aptima HCV Quant DX Assay (Diagnostic Test)
Standard of Care (Control)
Sites will continue with their standard of care for hepatitis C testing.
Outcomes
Primary Outcomes
Proportion of HCV RNA positive who initiate HCV treatment
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported