Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Médecins du Monde
Collaborators:
Burnet Institute International Network of People who Use Drugs UNITAID University of Bristol
Treatments:
Sofosbuvir Sofosbuvir-velpatasvir drug combination Velpatasvir