Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
- Conditions
- Hepatitis C, ChronicHepatitis C
- Interventions
- Diagnostic Test: Xpert HCV Viral Load FingerstickDiagnostic Test: Aptima HCV Quant DX Assay
- Registration Number
- NCT04014179
- Lead Sponsor
- Kirby Institute
- 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:
1. HCV testing from collected dried blood spots sent to a central laboratory
2. HCV testing using a point-of-care device at the NSP site
3. 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.
HCV RNA negative participants will have no further assessments or visits as part of the study protocol.
Participants who are HCV RNA positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. If eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (PBS) approved pan-genotypic HCV DAA treatment. Participants will be encouraged to take the first dose on the day of treatment work-up where possible. On-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice.
All HCV RNA positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Point-of-care RNA (Intervention) Xpert HCV Viral Load Fingerstick Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay. Dried Blood Spot (Intervention) Aptima HCV Quant DX Assay Blood samples will be tested for HCV RNA from dried blood spot cards.
- Primary Outcome Measures
Name Time Method Proportion of HCV RNA positive who initiate HCV treatment 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Coffs Harbour Primary NSP
🇦🇺Coffs Harbour, New South Wales, Australia
Liverpool Southwest NSP
🇦🇺Liverpool, New South Wales, Australia
UC Adelaide
🇦🇺Adelaide, South Australia, Australia
Wonggangga Turtpandi Aboriginal Primary Health Care Services
🇦🇺Adelaide, South Australia, Australia
Bankstown NSP
🇦🇺Bankstown, New South Wales, Australia
WSLHD Drug Health - Blacktown NSP
🇦🇺Blacktown, New South Wales, Australia
Gosford NSP
🇦🇺Gosford, New South Wales, Australia
Lismore Primary NSP
🇦🇺Lismore, New South Wales, Australia
Kempsey Primary NSP
🇦🇺Kempsey, New South Wales, Australia
Grafton Primary NSP
🇦🇺Grafton, New South Wales, Australia
Tweed Primary NSP
🇦🇺Tweed Heads, New South Wales, Australia
WSLHD Drug Health - Mt Druitt NSP
🇦🇺Mount Druitt, New South Wales, Australia
Orana Centre
🇦🇺Wollongong, New South Wales, Australia
Inala
🇦🇺Inala, Queensland, Australia
Alcohol and Drug Harm Reduction Biala
🇦🇺Brisbane, Queensland, Australia
Kobi House
🇦🇺Toowoomba, Queensland, Australia
Severin St NSP (Youth Link)
🇦🇺Cairns, Queensland, Australia
Northern DASSA
🇦🇺Elizabeth, South Australia, Australia
Noarlunga Health Precinct
🇦🇺Noarlunga, South Australia, Australia