Same-visit testing and treatment for Hepatitis C
Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
This study is testing if getting tested and treated for Hepatitis C on the same day can help people who inject drugs start treatment and get cured more effectively.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Macfarlane Burnet Institute for Medical Research and Public Health Ltd Academic / other |
| Locations | 6 sites (Clayton South, Victoria and 5 other locations) |
| Trial ID | NCT05016609 on ClinicalTrials.gov |
What this trial studies
The QuickStart Study evaluates the effectiveness of three different models of point-of-care testing and same-day treatment for Hepatitis C among people who inject drugs in primary healthcare settings across Australia. This cluster cross-over randomized controlled trial will involve 30 primary care services, each enrolling approximately 60 participants. The study aims to determine how these models impact the initiation of treatment and the overall cure rates for Hepatitis C. Participants will undergo rapid testing and, if diagnosed, will receive treatment according to standard care protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are current or former people who inject drugs, aged 18 years or older, who have not previously received treatment for Hepatitis C.
Not a fit: Patients who are currently pregnant, breastfeeding, or engaged in treatment for Hepatitis C may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the rates of Hepatitis C treatment initiation and cure among people who inject drugs.
How similar studies have performed: Other studies have shown promising results with similar point-of-care testing and treatment approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * current or former PWID (i.e., injected drugs at least once) * aged 18 years or over * attending a participating PHC for any reason * no previous treatment with DAAs for HCV * failed interferon based treatment for HCV in the past (i.e., did not achieve cure) * Medicare eligible * able to speak and understand English Exclusion Criteria: * women known to be currently pregnant or who are breastfeeding * individuals self-reporting to be currently engaged in treatment for HCV * unable to provide informed consent * tested for HCV in the past 3 months
Where this trial is running
Clayton South, Victoria and 5 other locations
- Mediclinic Australia — Clayton South, Victoria, Australia (Recruiting)
- Innerspace — Collingwood, Victoria, Australia (Recruiting)
- Corio Community Health Centre — Corio, Victoria, Australia (Recruiting)
- Cohealth Fitzroy — Fitzroy, Victoria, Australia (Recruiting)
- Homeless Healthcare — Highgate, Western Australia, Australia (Recruiting)
- Cockburn Wellbeing — Success, Western Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Joseph Doyle, MBBS, PhD — Burnet Institute
- Study coordinator: Caitlin Douglass, BHSc(Hons)
- Email: caitlin.douglass@burnet.edu.au
- Phone: +61404707275
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.