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Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-07-27
Primary completion: 2025-12-31
Study completion finish: 2025-12-31
Study type
HEALTH_SERVICES_RESEARCH
Phase
NA
Trial ID
NCT04014179
Intervention or treatment
DIAGNOSTIC_TEST: Xpert HCV Viral Load Fingerstick
DIAGNOSTIC_TEST: Aptima HCV Quant DX Assay
Conditions
- • Hepatitis C
- • Hepatitis C, Chronic
Find a site
Closest Location:
Bankstown NSP
Research sites nearby
Select from list below to view details:
Bankstown NSP
Bankstown, New South Wales, Australia
WSLHD Drug Health - Blacktown NSP
Blacktown, New South Wales, Australia
Coffs Harbour Primary NSP
Coffs Harbour, New South Wales, Australia
Gosford NSP
Gosford, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dried Blood Spot (Intervention)
| DIAGNOSTIC_TEST: Aptima HCV Quant DX Assay
|
EXPERIMENTAL: Point-of-care RNA (Intervention)
| DIAGNOSTIC_TEST: Xpert HCV Viral Load Fingerstick
|
NO_INTERVENTION: Standard of Care (Control)
| Not specified |
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Proportion of HCV RNA positive who initiate HCV treatment | 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. | 12 weeks from Enrolment |
Secondary outcome
Frequently Asked Questions
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