Simplified hepatitis C testing with same-day treatment 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

This project will test whether a simplified pathway that starts hepatitis C treatment the same day after a quick antibody test helps people who inject drugs in Armenia, Georgia, and Tanzania get treated and cured faster than the usual antibody-plus-RNA pathway.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 3040 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Médecins du Monde (other)
• Locations: 1 site (Yerevan)
• Trial ID: NCT06159504 on ClinicalTrials.gov

What this trial studies

This is a non-randomised, quasi-experimental prospective comparison of two simplified care pathways delivered in community and harm-reduction settings across Armenia, Georgia, and Tanzania. One arm follows a standard simplified model with a rapid antibody test followed by a confirmatory HCV RNA test before treatment, while the other arm starts treatment the same day based on an early (<5 minute) read of the rapid antibody test with RNA testing done after treatment initiation. Approximately 350 participants per arm will receive 12 weeks of oral sofosbuvir/velpatasvir and be followed to measure treatment start rates, sustained virological response (SVR12), feasibility across the care cascade, cost-effectiveness, and acceptability using qualitative interviews. Outcomes will compare treatment uptake, cure rates, concordance between early antibody reads and RNA, and the economic implications of the two approaches.

Who should consider this trial

Good fit: Adults (18+) who inject drugs or attend needle/syringe programs, able to consent in the local language, not currently or previously treated for hepatitis C, and meeting the study's medical eligibility criteria are the ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have a history of decompensated cirrhosis, uncontrolled significant comorbidities (for example uncontrolled HIV, renal dysfunction, active tuberculosis, or chronic hepatitis B), or cannot stop contraindicated medications are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the same-day antibody-driven pathway could lower barriers to care, speed treatment starts, reduce loss-to-follow-up, and lower program costs for people who inject drugs.

How similar studies have performed: Point-of-care HCV testing and same-day treatment models have improved uptake in some settings and early-read antibody results have been correlated with RNA positivity, but starting treatment without pre-treatment RNA confirmation is relatively novel and not yet widely validated.

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

Where this trial is running

Yerevan

• National Institute for Infectious Diseases — Yerevan, Armenia (RECRUITING)

Study contacts

• Principal investigator: Margaret Hellard — Burnet
• Study coordinator: Bridget Draper

Conditions: Hepatitis C, RDT, Point of care, Nucleic acid testing, Qualitative interviews, Feasibility, Acceptability, Cost-effectiveness