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Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania

Study acronym: CUTTS HepC
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Interventions: Shortened read time of rapid diagnostic test for hepatitis C virus. (Diagnostic Test), sofosbuvir/velpatasvir (SOF/VEL) (Drug) to Shortened read time of rapid diagnostic test for hepatitis C virus. (Diagnostic Test), sofosbuvir/velpatasvir (SOF/VEL) (Drug) Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 2 of 7 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2024 to Oct 3, 2024 · Study sites: 0 to 1 · Study description expanded, about 1 wordv2 Show 3 more changesShow less
    • Start date changed from estimate of Mar 2024 to Oct 3, 2024
    • Study sites: 0 to 1
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06159504
Lead Sponsor Médecins du Monde
Collaborators: UNITAID, Burnet Institute, University of Bristol, International Network of People who Use Drugs
Conditions Hepatitis C, RDT
Enrollment 3,040 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov