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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03935906
Ethics application status
Date submitted
15/04/2019
Date registered
2/05/2019

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
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.
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).
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.
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.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Assess the impact of baseline blood tests on treatment decisions.
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
Accrual to date
Final
210
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised Individual Participant Data (IPD) will be retained by the study team. Access to IPD will be granted to researchers who supply a methodologically sound proposal. Access will be granted in line with prevailing recommendations via a reputable online controlled access repository. Requests for data access should be sent to the corresponding author (ORCID: 0000-0002-7586-7712). Data which may be shared include all IPD collected during the trial which underlie the final published results, after de-identification; the study protocol; the SAP; the Data Management Plan (DMP).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Post-publication of final results for a period of 3 years.
Available to whom?
Researchers who supply a methodologically sound proposal.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03935906