NCT06159504 Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
| NCT ID | NCT06159504 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Médecins du Monde |
| Condition | Hepatitis C |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,040 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 3,040 participants in total. It began in 2024-10-03 with a primary completion date of 2026-12.
⚠ 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 goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania. The main questions it aims to answer are: 1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries? 2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test? 3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody/confirmatory RNA test) model? Participants will: * be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2) * if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. * if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. Researchers will compare cure and participant retention rates between the two groups.
Eligibility Criteria
Inclusion Criteria: * 18 years or older * Able and willing to provide informed consent in local language * Not currently on or previously had treatment for hepatitis C * Attending site for needle / syringe program, OR self-reports ever injecting drugs Exclusion Criteria: * Self-reported history of decompensate cirrhosis of the liver * Women who are pregnant or breast-feeding * Self-report other significant co-morbidities such as uncontrolled HIV infection, history of renal dysfunction, tuberculosis infection, or chronic hepatitis B infection * Unable / unwilling to stop any contraindicated medications / supplements
Contact & Investigator
Margaret Hellard
PRINCIPAL INVESTIGATOR
Burnet
Frequently Asked Questions
Who can join the NCT06159504 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.
What phase is the NCT06159504 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06159504 currently recruiting?
Yes, NCT06159504 is actively recruiting participants. Contact the research team at bridget.draper@burnet.edu.au for enrollment information.
Where is the NCT06159504 trial being conducted?
This trial is being conducted at Yerevan, Armenia.
Who is sponsoring the NCT06159504 clinical trial?
NCT06159504 is sponsored by Médecins du Monde. The principal investigator is Margaret Hellard at Burnet. The trial plans to enroll 3,040 participants.