Clinical trial NCT06159504: Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Official title: Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hepatitis C
RDT
Keywords: Point of care (PoC)
Nucleic acid testing
Qualitative interviews
Feasibility
Acceptability
Cost-effectiveness
Modelling
Lead sponsor: Médecins du Monde
Sponsor class: OTHER
Collaborators: name: UNITAID
name: Burnet Institute
name: University of Bristol
name: International Network of People who Use Drugs
First posted: 2023-12-06
Enrollment: 3040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups will be running in tandem/parallel to one another at the same time.
Primary purpose: TREATMENT

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:

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.

Detailed description: We 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
measure: The proportion of participants initiating hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
timeFrame: 3 years
measure: The proportion of participants who achieve SVR following hepatitis C treatment in simplified care Arm vs same-day treatment Arm.
timeFrame: 3 years
measure: The comparative cost and cost-effectiveness of simplified care vs same-day treatment models of care.
timeFrame: 3 years
Secondary outcomes:
measure: Participant acceptability of the hepatitis C simplified care and same-day treatment care models.
timeFrame: 3 years
measure: Practitioner acceptability of hepatitis C simplified care and same-day treatment care models
timeFrame: 3 years
measure: The time to treatment initiation among participants in simplified care Arm vs same-day treatment Arm
timeFrame: 3 years
measure: The proportion of participants who complete hepatitis C treatment in simplified care Arm vs same-day treatment Arm
timeFrame: 3 years
measure: The proportion of participants whose hepatitis C antibody test result at 5-min read-time concords with RNA test results.
timeFrame: 3 years
measure: Identification of the optimal "cut-off" read-time for hepatitis C antibody test to predict RNA positivity
timeFrame: 3 years
measure: The proportion of participants "overtreated" for hepatitis C in the same-day treatment Arm.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Burnet
name: Margaret Hellard
role: PRINCIPAL_INVESTIGATOR
References: