Actively Recruiting
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Led by Médecins du Monde · Updated on 2025-07-18
3040
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
M
Médecins du Monde
Lead Sponsor
U
UNITAID
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institute for Infectious Diseases
Yerevan, Armenia
Actively Recruiting
Research Team
B
Bridget Draper
CONTACT
M
Margaret Hellard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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