An Early Phase 1 interventional study of sofosbuvir/velpatasvir (SOF/VEL) and Shortened read time of rapid diagnostic test for hepatitis C virus. in Hepatitis C and RDT, sponsored by Médecins du Monde. Recruiting at 1 site in Armenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Médecins du Monde · Early Phase 1, Interventional, and Treatment
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:
Participants will:
Researchers will compare cure and participant retention rates between the two groups.
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.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 3,040 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Médecins du Monde is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
Drug pages: Sofosbuvir · Velpatasvir
400mg of SOF and 100mg of VEL self administered daily as a tablet.
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
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.
Time frame: 3 years
The proportion of participants initiating hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
Time frame: 3 years
The proportion of participants who achieve SVR following hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
Time frame: 3 years
The comparative cost and cost-effectiveness of simplified care vs same-day treatment models of care.
Time frame: 3 years
Participant acceptability of the hepatitis C simplified care and same-day treatment care models.
Measured through interviews and surveys
Time frame: 3 years
Practitioner acceptability of hepatitis C simplified care and same-day treatment care models
Measured through interviews
Time frame: 3 years
The time to treatment initiation among participants in simplified care Arm vs same-day treatment Arm
Time frame: 3 years
The proportion of participants who complete hepatitis C treatment in simplified care Arm vs same-day treatment Arm
Time frame: 3 years
The proportion of participants whose hepatitis C antibody test result at 5-min read-time concords with RNA test results.
Time frame: 3 years
Identification of the optimal "cut-off" read-time for hepatitis C antibody test to predict RNA positivity
Time frame: 3 years
The proportion of participants "overtreated" for hepatitis C in the same-day treatment Arm.
Time frame: 3 years
Plan to share: Undecided
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 45 phase 1 interventional studies under Hepatitis C, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 22. This study's planned 26 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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