About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
sofosbuvir/velpatasvir (SOF/VEL)
Drug400mg of SOF and 100mg of VEL self administered daily as a tablet.
Shortened read time of rapid diagnostic test for hepatitis C virus.
Diagnostic testAdministered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.
Treatment groups
Trial outcomes
Primary outcomes
The feasibility of implementing a hepatitis C simplified care (Arm 1) and same-day treatment (Arm 2) care models in community and harm reduction settings in the three study countries.
Measured through case report forms, interviews and study site checks.
The proportion of participants initiating hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
The proportion of participants who achieve SVR following hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
The comparative cost and cost-effectiveness of simplified care vs same-day treatment models of care.
Secondary outcomes
Participant acceptability of the hepatitis C simplified care and same-day treatment care models.
Measured through interviews and surveys
Practitioner acceptability of hepatitis C simplified care and same-day treatment care models
Measured through interviews
The time to treatment initiation among participants in simplified care Arm vs same-day treatment Arm
The proportion of participants who complete hepatitis C treatment in simplified care Arm vs same-day treatment Arm
Sponsors and contacts
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Médecins du Monde
Lead sponsor
UNITAID
Collaborator
Burnet Institute
Collaborator
University of Bristol
Collaborator
International Network of People who Use Drugs
Collaborator