RECRUITING Early Phase 1 ClinicalTrials.gov

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

Sponsor: Médecins du Monde • ClinicalTrials.gov ID: NCT06159504

Registry updated: 2026-10-09

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

sofosbuvir/velpatasvir (SOF/VEL) (Drug)
400mg of SOF and 100mg of VEL self administered daily as a tablet.
Shortened read time of rapid diagnostic test for hepatitis C virus. (Diagnostic test)
Administered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.

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

Conditions

Hepatitis C RDT

Locations

National Institute for Infectious Diseases — Yerevan, Armenia

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment