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

The investigators will conduct a study to trial a new, simplified, and lower cost clinical pathway and determine its feasibility, effectiveness, cost-effectiveness and acceptability in Armenia, Georgia, and Tanzania.

This is a non-randomised, quasi-experimental, prospective comparative trial with approximately 350 participants initiated onto hepatitis C treatment in each arm. Arm one is a simplified care model (following global guidance) with hepatitis C treatment commencing after a rapid hepatitis C antibody test and a confirmatory positive hepatitis C ribonucleic acid (RNA) test. Arm two will involve same day treatment commencement following a positive rapid antibody test without confirmatory RNA testing prior to treatment initiation (RNA testing will be completed after treatment is provided). In arm two, the decision to treat will be based on the result of an early read time (< 5 mins) of a rapid antibody test which previous research findings suggest correlates strongly with a hepatitis C RNA positive test result. All positive participants will be treated with sofosbuvir (400mg) and velpatasvir (100mg), self-administered orally once per day for 12 weeks. Hepatitis C cure will be assessed by sustained virological response (SVR) laboratory testing.

The first primary outcome is feasibility, measured throughout the care cascade. Primary outcomes compared across the two arms will be the proportion of participants 1) commencing treatment and 2) achieving SVR. Test concordance and validity of the early read time will be assessed against laboratory RNA test results (which will also guide decisions to continue or cease treatment in Arm 2). A mixed effects model will be used to assess study outcomes and infectious diseases modelling will determine cost-effectiveness. The acceptability and feasibility of the models will be assessed through thematic analysis of participant and practitioner interviews, and site assessments.

• 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), also known as OraQuick® HCV RDT: Administered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.

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. [3 years]: 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. [3 years]
• The proportion of participants who achieve SVR following hepatitis C treatment in simplified care Arm vs same-day treatment Arm. [3 years]
• The comparative cost and cost-effectiveness of simplified care vs same-day treatment models of care. [3 years]

Secondary outcomes

• Participant acceptability of the hepatitis C simplified care and same-day treatment care models. [3 years]: Measured through interviews and surveys
• Practitioner acceptability of hepatitis C simplified care and same-day treatment care models [3 years]: Measured through interviews
• The time to treatment initiation among participants in simplified care Arm vs same-day treatment Arm [3 years]
• The proportion of participants who complete hepatitis C treatment in simplified care Arm vs same-day treatment Arm [3 years]
• The proportion of participants whose hepatitis C antibody test result at 5-min read-time concords with RNA test results. [3 years]
• Identification of the optimal "cut-off" read-time for hepatitis C antibody test to predict RNA positivity [3 years]
• The proportion of participants "overtreated" for hepatitis C in the same-day treatment Arm. [3 years]

Sex: All, ages: 18 Years to any

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

• Results publication: Draper BL, Flynn M, Schroeder S, Wisse E, Aikaeli F, Han ZM, Ayako M, Bajis S, Butsashvili M, Davtyan K, Kordzadze T, Lamand P, Luhmann N, Sargsyan K, Senkoro M, Scott N, Stone J, Vickerman P, Voloshin A, Walker J, Madden A, Stoove MA, Hellard M, Pedrana A; CUTTS HepC Consortium, Hepatitis C Models of Care Study Team. Non-randomised trial of a hepatitis C same-day test and treat model using antibody test only for people who inject drugs in Armenia, Georgia and Tanzania: a CUTTS HepC study protocol. BMJ Open. 2026 Mar 24;16(3):e114119. doi: 10.1136/bmjopen-2025-114119. PMID 41876153

• Margaret Hellard, Principal investigator, Burnet