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RECRUITINGEarly Phase 1INTERVENTIONAL

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

Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 years or older - Able and willing to provide willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

sofosbuvir/velpatasvir (SOF/VEL)

400mg of SOF and 100mg of VEL self administered daily as a tablet.

DIAGNOSTIC_TEST

Shortened read time of rapid diagnostic test for hepatitis C virus.

Administered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.

Locations (1)

National Institute for Infectious Diseases
Yerevan, Armenia