NCT05042544 The Australian HCV Point-of-Care Testing Program
| NCT ID | NCT05042544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kirby Institute |
| Condition | Hepatitis C |
| Study Type | OBSERVATIONAL |
| Enrollment | 60,000 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60,000 participants in total. It began in 2022-02-23 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
Eligibility Criteria
Inclusion Criteria: 1. Provided informed consent. 2. ≥ 18 years of age. 3. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV). OR: 4. Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services). Exclusion Criteria: a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05042544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis C. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05042544 currently recruiting?
Yes, NCT05042544 is actively recruiting participants. Contact the research team at dsilk@kirby.unsw.edu.au for enrollment information.
Where is the NCT05042544 trial being conducted?
This trial is being conducted at Canberra, Australia, Bathurst, Australia, Broken Hill, Australia, Broken Hill, Australia and 11 additional locations.
Who is sponsoring the NCT05042544 clinical trial?
NCT05042544 is sponsored by Kirby Institute. The trial plans to enroll 60,000 participants.