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

NCT06159504 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: CUTTS HepC / HCV MoC
• Study Type: interventional
• Target: 3,040
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Hepatitis C; RDT

Keywords

Point of care (PoC); Nucleic acid testing; Qualitative interviews; Feasibility; Acceptability; Cost-effectiveness; Modelling

Outcome Measures

Primary Outcomes (4)

• 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.

  Measured through case report forms, interviews and study site checks.

  3 years

• 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 (7)

• Participant acceptability of the hepatitis C simplified care and same-day treatment care models.

  3 years

• Practitioner acceptability of hepatitis C simplified care and same-day treatment care models

  3 years

• 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

Study Arms (2)

Arm 1 - simplified care model

ACTIVE COMPARATOR

Arm 1 will receive DAA medication at the second appointment following the return of RNA HCV results. They will receive sofosbuvir (400mg) and velpatasvir (100mg).

Drug: sofosbuvir/velpatasvir (SOF/VEL)

Arm 2 - short read time

EXPERIMENTAL

Arm 2 will begin DAA treatment after the first appointment following a shortened RDT read time of 5 minutes rather than 20 minutes. They will receive sofosbuvir (400mg) and velpatasvir (100mg).

Drug: sofosbuvir/velpatasvir (SOF/VEL); Diagnostic Test: Shortened read time of rapid diagnostic test for hepatitis C virus.

Interventions

sofosbuvir/velpatasvir (SOF/VEL) DRUG

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

Arm 1 - simplified care model; Arm 2 - short read time

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.

Also known as: OraQuick® HCV RDT

Arm 2 - short read time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Médecins du Monde: lead
• UNITAID: collaborator
• Burnet Institute: collaborator
• University of Bristol: collaborator
• International Network of People who Use Drugs: collaborator

Study Sites (1)

National Institute for Infectious Diseases

Yerevan, Armenia

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; velpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Margaret Hellard

  Burnet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridget Draper

CONTACT

+61 413 272 698; bridget.draper@burnet.edu.au

Margaret Hellard

CONTACT

margaret.hellard@burnet.edu.au

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two study groups will be running in tandem/parallel to one another at the same time.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

AR (1)