RecruitingEarly Phase 1NCT06159504

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


Sponsor

Médecins du Monde

Enrollment

3,040 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a simplified treatment pathway to make hepatitis C treatment easier to access for people who inject drugs, delivered through needle exchange and harm reduction programs. **You may be eligible if...** - You are 18 years or older - You attend a needle and syringe program or currently inject drugs - You have not been previously treated for hepatitis C - You are able to provide informed consent **You may NOT be eligible if...** - You have advanced liver disease (decompensated cirrhosis) - You are pregnant or breastfeeding - You have uncontrolled HIV, serious kidney problems, tuberculosis, or chronic hepatitis B - You are taking medications that interact with the study treatment and cannot stop them Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsofosbuvir/velpatasvir (SOF/VEL)

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

DIAGNOSTIC_TESTShortened 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

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NCT06159504


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