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

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.

Conditions

• Hepatitis C
• RDT

Interventions

DRUG

sofosbuvir/velpatasvir (SOF/VEL)

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

DIAGNOSTIC_TEST

Shortened 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.

Sponsors & Collaborators

• UNITAID

  collaborator OTHER

• Burnet Institute

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• International Network of People who Use Drugs

  collaborator UNKNOWN

• Médecins du Monde

  lead OTHER

Principal Investigators

• Margaret Hellard · Burnet

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-03

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• Armenia

Study Locations