Improving Hepatitis C testing and treatment for people who inject drugs
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
This study is testing two new ways to test for Hepatitis C in people who inject drugs to see if they can help more of them get treated compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kirby Institute Government |
| Locations | 19 sites (Bankstown, New South Wales and 18 other locations) |
| Trial ID | NCT04014179 on ClinicalTrials.gov |
What this trial studies
This project evaluates two innovative strategies for Hepatitis C virus (HCV) testing compared to standard care among individuals who inject drugs at needle and syringe programs in Australia. The study compares dried blood spot testing and point-of-care testing to enhance the uptake of HCV treatment following diagnosis. Participants will be randomly assigned to one of three testing methods, and peer support will be provided to facilitate engagement and linkage to care. The goal is to enroll a total of 450 HCV RNA positive participants across various sites.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently injected drugs and are attending needle and syringe programs.
Not a fit: Patients who do not inject drugs or are not attending needle and syringe programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the number of individuals diagnosed with Hepatitis C who initiate treatment.
How similar studies have performed: Other studies have shown success with similar approaches in enhancing HCV testing and treatment uptake among high-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for participants: Attendees of the NSP service are eligible for inclusion if the following criteria are met: 1. Provided written informed consent 2. ≥ 18 years of age 3. 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.
Where this trial is running
Bankstown, New South Wales and 18 other locations
- Bankstown NSP — Bankstown, New South Wales, Australia (Not_yet_recruiting)
- WSLHD Drug Health - Blacktown NSP — Blacktown, New South Wales, Australia (Recruiting)
- Coffs Harbour Primary NSP — Coffs Harbour, New South Wales, Australia (Recruiting)
- Gosford NSP — Gosford, New South Wales, Australia (Not_yet_recruiting)
- Grafton Primary NSP — Grafton, New South Wales, Australia (Recruiting)
- Kempsey Primary NSP — Kempsey, New South Wales, Australia (Recruiting)
- Lismore Primary NSP — Lismore, New South Wales, Australia (Withdrawn)
- Liverpool Southwest NSP — Liverpool, New South Wales, Australia (Recruiting)
- WSLHD Drug Health - Mt Druitt NSP — Mount Druitt, New South Wales, Australia (Recruiting)
- Tweed Primary NSP — Tweed Heads, New South Wales, Australia (Withdrawn)
- Orana Centre — Wollongong, New South Wales, Australia (Recruiting)
- Alcohol and Drug Harm Reduction Biala — Brisbane, Queensland, Australia (Recruiting)
- Severin St NSP (Youth Link) — Cairns, Queensland, Australia (Not_yet_recruiting)
- Inala — Inala, Queensland, Australia (Not_yet_recruiting)
- Kobi House — Toowoomba, Queensland, Australia (Recruiting)
- UC Adelaide — Adelaide, South Australia, Australia (Active_not_recruiting)
- Wonggangga Turtpandi Aboriginal Primary Health Care Services — Adelaide, South Australia, Australia (Active_not_recruiting)
- Northern DASSA — Elizabeth, South Australia, Australia (Active_not_recruiting)
- Noarlunga Health Precinct — Noarlunga, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Elise Tu, PhD
- Email: etu@kirby.unsw.edu.au
- Phone: 61-2-9385-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.