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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03935906




Registration number
NCT03935906
Ethics application status
Date submitted
15/04/2019
Date registered
2/05/2019
Date last updated
17/06/2019

Titles & IDs
Public title
Reaching mEthadone Users Attending Community pHarmacies With HCV
Scientific title
Reaching mEthadone Users Attending Community pHarmacies With HCV
Secondary ID [1] 0 0
1-025-18
Universal Trial Number (UTN)
Trial acronym
REACH HCV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Reach Pathway
Other interventions - Education-only Pathway

Experimental: Reach Pathway - Community pharmacist will explain the risks of contracting HCV from current or historical intravenous drug use. OST patients will then meet with an outreach hepatology nurse specialist who will perform a diagnostic point-of-care (PoC) HCV test along with venepuncture for safety blood tests and confirmatory HCV RNA on the pharmacy premises. The nurse will return for a subsequent visit to prescribe (in the UK; in Australia prescribing is undertaken by qualified medic) and deliver HCV medication for participants who test positive, which will be dispensed alongside their OST schedule by their community pharmacist. The outreach nurse will return after approximately 14 days to confirm negative results, dispense medication for new patients with positive results (PCR positive but below limit of detection of POC test) and confirm follow up appointments where required. The RNA and PoC test will also be administered for sustained viral response at 12 weeks post treatment (SVR12).

Experimental: Education-only Pathway - The community pharmacist will discuss the risks of contracting HCV through current or historical intravenous drug use. The community pharmacist will then advise participants on the nearest centre for HCV testing and treatment, as is standard of care for the countries included in this study. If they are referred from a REACH pharmacy, they will present a reply slip and/or the Patient Information Sheet to the nurse who will then consent the participant, perform HCV and safety blood tests, and complete the study paperwork. The participant's medication will be delivered to, and dispensed from, their community pharmacy alongside their OST. Participants will return to the local BBV clinic for an SVR12 test after completing treatment.


Other interventions: Reach Pathway
Trial of outreach nurse offering point-of-care Hepatitis C (HCV) testing to opiate substitution therapy patients in community pharmacies, which is hypothesised to improve number of patients tested and cured of HCV.

Other interventions: Education-only Pathway
Trial of community pharmacists advising opiate substitution therapy patients to attend a local blood-borne virus clinic to be tested for Hepatitis C by a specialist nurse, which represents the standard care pathway for HCV patients in the countries included in the study.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SVR12 - Proportion of patients in a population of stable opiate substitution therapy patients achieving Sustained Viral Response at 12 weeks post-treatment in the REACH pathway versus education-only pathway (Intention to Treat analysis).
Timepoint [1] 0 0
12 weeks after participants finish their hepatitis C treatment regimen
Secondary outcome [1] 0 0
Determine whether the REACH pathway compared with the education only pathway leads to more people on opiate substitution therapy who are confirmed HCV RNA positive being treated and cured. - Percentage of patients achieving Sustained Viral Response at 12 weeks post-treatment from the patient population that tested positive for HCV in each arm (modified Intention to Treat analysis).
Timepoint [1] 0 0
12 weeks after participants finish their hepatitis C treatment regimen
Secondary outcome [2] 0 0
Cost-effectiveness analysis of the REACH pathway versus the education-only pathway, from the perspective of the NHS (UK) and Medicare (Australia). - Incremental cost-effectiveness ratio to consider the epidemiological impact of scaling up the intervention to all pharmacies in a specific setting in Australia, Scotland and Wales; and cost-benefit calculations (e.g. cost per HCV diagnosis; cost per SVR12; cost per HCV infection averted; number needed to screen).
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Determine whether the REACH pathway compared with the education-only pathway leads to more people on opiate substitution therapy being tested for HCV. - Proportion of patients being tested for HCV in each arm
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Compare adherence and persistence to HCV therapy in the Reach pathway to the education-only pathway. - Proportion of patients adhering to therapy in each arm (taking = 85% of prescribed tablets) as reported in the observed therapy adherence log.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Assess the impact of baseline blood tests on treatment decisions. - Proportion of patients in whom changes in therapy are advised due to blood test results, as recorded at start of HCV therapy.
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
- Over 18 years of age.

- Previous or current injecting drug user.

- Stable OST dose for greater than 12 weeks prior to study enrolment.

- Glecaprevir/pibrentasvir treatment naïve.

- Able to voluntarily sign and date an informed consent form prior to initiation of any
screening or study specific procedures.

- Able to understand and adhere to study visit schedule and all other protocol
requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Female who is pregnant, planning to become pregnant or breastfeeding or
unwilling/unable to take appropriate birth control.

- Known current HIV infection.

- Known current HBV infection. Serological: patients with a positive HBsAg or isolated
positive anti-HBC will be excluded from the study and followed up in secondary care.

- Previous treatment with glecaprevir/pibrentasvir.

- Currently taking any concomitant medication that has a warning of'do not
co-administer' with glecaprevir and/or pibrentasvir as defined by the Liverpool Hep
drug interactions website and product SmPC.

- Clinically significant abnormalities that make candidate unsuitable for this study in
the opinion of the investigator including but not limited to:

- Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic,
psychiatric or other medical disease or disorder, which is unrelated to existing HCV
infection.

- History of either current or previous decompensated liver disease or symptoms/signs of
decompensation e.g. ascites noted on physical exam, use of beta-blockers for portal
hypertension, hepatic encephalopathy or oesophageal variceal bleeding.

- Candidate is deemed unsuitable to receive study drugs by the study investigator, for
any reason according to clinical judgement.

- Unable or unwilling to provide informed consent.

- History of severe, life-threatening or other significant sensitivity to any excipients
of the study drugs.

- Drug-drug Interaction which may have safety concerns with any concomitant medication
the patient is receiving including non-prescribed and/or recreational drugs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Burnet Institute - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Scotland
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
University of Dundee
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Public Health Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Burnet Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Hepatitis C Virus (HCV) is a blood-borne virus that damages the liver and is a major public
health threat globally. Most individuals infected with HCV are unaware of it and show no
symptoms until presenting with incurable, fatal end-stage disease. In Scotland and Australia
approximately 0.7% of the general population has chronic HCV with 0.4% in Wales, and they are
at risk of developing cirrhosis and hepatocellular carcinoma. The clinical challenge is to
identify those infected and bring them into treatment before the disease advances.

The greatest risk factor for acquiring HCV in many countries is through injecting drug use.
On the road to recovery from drug use, many will receive long-term opiate substitution
therapy (OST), commonly with methadone or buprenorphine. Internationally, OST is routinely
dispensed by a community pharmacist. HCV testing can be offered by GPs, drugs workers, drug
agencies, social workers, community pharmacies and needle exchange sites. Once patients are
diagnosed, they are referred to a hospital-based service to receive anti-HCV treatment. In
this pathway, less than 10% of the OST population is tested per year, and cumulative rates of
testing are less than 50% of those on OST.

Highly effective Directly Acting Antiviral (DAA) treatment combinations are now available and
achieve HCV cure rates in excess of 95%, with once or twice daily tablets for 8-24 weeks.

The REACH HCV study will compare efficacy of an education-only HCV referral and treatment
pathway against a nurse-led point-of-care device testing and treatment pathway among OST
patients in community pharmacies in Scotland, Wales and Australia. Eligible participants will
be treated using DAAs.
Trial website
https://clinicaltrials.gov/show/NCT03935906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brendan Healy, PhD
Address 0 0
Public Health Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christopher J Byrne, MSc
Address 0 0
Country 0 0
Phone 0 0
00441382383217
Fax 0 0
Email 0 0
c.x.byrne@dundee.ac.uk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03935906