Hepatitis CREACH-HCVNCT03935906
Reaching mEthadone Users Attending Community pHarmacies With HCV
A study testing Reach Pathway and Education-only Pathway in people with Hepatitis C, run by University of Dundee at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Reach Pathway and Education-only Pathway
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Oct 2019to 14 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Public Health Wales
Cardiff, Wales
NHS Tayside
Dundee, Scotland
About this study
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.
Read more
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.
Read the detailed description
The REACH HCV study is an international, cluster-randomised non-clinical trial with two arms. The unit of randomisation is the community pharmacy, so all participants in a given pharmacy are allocated to one of two pathways for HCV testing and treatment. There are three participating hubs located in: Scotland, Wales and Australia respectively.
The sample size is 140 participants, equally split between the three participating hubs, and the trial population is patients receiving opiate substitution therapy (OST) in community pharmacies.
Arm 1 (REACH arm): The community pharmacist will take the opportunity to explain the risks of contracting HCV from current or historical intravenous drug use. The OST patients will then meet with an outreach hepatology nurse specialist who will consent the patients and perform a diagnostic point-of-care (PoC) HCV test along with venepuncture for safety laboratory blood tests and confirmatory HCV RNA. The outreach 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 those patients who test positive, which will be dispensed to participants 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).
Arm 2 (Education-only arm): 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.
All eligible HCV-infected participants will receive treatment with 100mg glecaprevir/40mg pibrentasvir (Maviret) a pan-genotypic Direct Acting Antiviral (DAA) for between 8-16 weeks, depending on blood test results. The study is planned to run for a total of two years, with one year clinical phase and one year follow-up phase.
- Conditions
- Hepatitis C
- Being tested
- Reach Pathway, Education-only Pathway
- Keywords
- Point of Care, Direct Acting Antivirals, Community Pharmacy, Opiate Substitution Therapy
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach PathwayOther
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.
Education-only PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reach Pathway | Experimental | 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). Receives: Other: Reach Pathway |
| Education-only Pathway | Experimental | 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. Receives: Other: Education-only Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Percentage 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).
Measured: 12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.
Secondary outcomes (7)
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).
Measured: 12 weeks after participants finish their hepatitis C treatment regimen
Determine Whether the REACH Pathway Compared With the Education-only Pathway Leads to More People on Opiate Substitution Therapy Being Tested for HCV.
Percentage of patients being tested for HCV in each arm
Measured: Up to 30 weeks
Compare Adherence and Persistence to HCV Therapy in the Reach Pathway to the Education-only Pathway.
Percentage of patients adhering to therapy in each arm (taking ≥ 85% of prescribed tablets) as reported in the observed therapy adherence log.
Measured: Up to 16 weeks
Assess the Impact of Baseline Blood Tests on Treatment Decisions.
Percentage of patients in whom changes in therapy are advised due to blood test results, as recorded at start of HCV therapy.
Measured: 2 weeks
Number of Participants Tested for HCV
Count of number of eligible participants tested for HCV
Measured: 16 months
Number of Participants Treated for HCV
Number of eligible participants treated for HCV
Measured: 12 months
Number of Participants Achieved SVR
Number of eligible participants who achieved SVR (cured of HCV infection)
Measured: 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start8 Oct 2019
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Wales, Burnet Institute
- Responsible party
- Principal investigator, John Dillon, University of Dundee
- Investigators
- Brendan Healy, PhD, Principal investigator, Public Health WalesJoseph Doyle, PhD, Principal investigator, Macfarlane Burnet Institute for Medical Research and Public HealthJohn F Dillon, PhD, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935906
- Sponsor's protocol ID
- 1-025-18
- Acronym
- REACH-HCV
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2019
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Byrne CJ, Radley A, Inglis SK, Beer L, Palmer N, Duc Pham M, Allardice K, Wang H, Robinson E, Hermansson M, Semizarov D, Healy B, Doyle JS, Dillon JF. Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial. Aliment Pharmacol Ther. 2022 Jun;55(12):1512-1523. doi: 10.1111/apt.16953. Epub 2022 May 10.
PubMed 35538396Byrne C, Radley A, Inglis SK, Beer LJZ, Palmer N, Pham MD, Healy B, Doyle JS, Donnan P, Dillon JF. Reaching mEthadone users Attending Community pHarmacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV). BMJ Open. 2020 Aug 30;10(8):e036501. doi: 10.1136/bmjopen-2019-036501.
PubMed 32868356
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching mEthadone Users Attending Community pHarmacies With HCV
- ClinicalTrials.gov ID
- NCT03935906
- Acronym / sponsor ID
- REACH-HCV / 1-025-18
- Conditions
- Hepatitis C
- Keywords
- Point of Care, Direct Acting Antivirals, Community Pharmacy, Opiate Substitution Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,410 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Public Health Wales, Burnet Institute
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The REACH HCV study is an international, cluster-randomised non-clinical trial with two arms. The unit of randomisation is the community pharmacy, so all participants in a given pharmacy are allocated to one of two pathways for HCV testing and treatment. There are three participating hubs located in: Scotland, Wales and Australia respectively.
The sample size is 140 participants, equally split between the three participating hubs, and the trial population is patients receiving opiate substitution therapy (OST) in community pharmacies.
Arm 1 (REACH arm): The community pharmacist will take the opportunity to explain the risks of contracting HCV from current or historical intravenous drug use. The OST patients will then meet with an outreach hepatology nurse specialist who will consent the patients and perform a diagnostic point-of-care (PoC) HCV test along with venepuncture for safety laboratory blood tests and confirmatory HCV RNA. The outreach 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 those patients who test positive, which will be dispensed to participants 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).
Arm 2 (Education-only arm): 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.
All eligible HCV-infected participants will receive treatment with 100mg glecaprevir/40mg pibrentasvir (Maviret) a pan-genotypic Direct Acting Antiviral (DAA) for between 8-16 weeks, depending on blood test results. The study is planned to run for a total of two years, with one year clinical phase and one year follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reach Pathway | Experimental | Other: Reach PathwayCommunity 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). |
| Education-only Pathway | Experimental | Other: Education-only PathwayThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach PathwayTrial 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 | Reach Pathway |
| Education-only PathwayTrial 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. | Other | Education-only Pathway |
Primary outcome
SVR12
Time frame: 12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.
Percentage 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).
7 secondary outcomes
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.
Time frame: 12 weeks after participants finish their hepatitis C treatment regimen
Determine Whether the REACH Pathway Compared With the Education-only Pathway Leads to More People on Opiate Substitution Therapy Being Tested for HCV.
Time frame: Up to 30 weeks
Compare Adherence and Persistence to HCV Therapy in the Reach Pathway to the Education-only Pathway.
Time frame: Up to 16 weeks
Assess the Impact of Baseline Blood Tests on Treatment Decisions.
Time frame: 2 weeks
Number of Participants Tested for HCV
Time frame: 16 months
Number of Participants Treated for HCV
Time frame: 12 months
Number of Participants Achieved SVR
Time frame: 12 weeks after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35538396Byrne CJ, Radley A, Inglis SK, Beer L, Palmer N, Duc Pham M, Allardice K, Wang H, Robinson E, Hermansson M, Semizarov D, Healy B, Doyle JS, Dillon JF. Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial. Aliment Pharmacol Ther. 2022 Jun;55(12):1512-1523. doi: 10.1111/apt.16953. Epub 2022 May 10.
- Derived from this study: PubMed 32868356Byrne C, Radley A, Inglis SK, Beer LJZ, Palmer N, Pham MD, Healy B, Doyle JS, Donnan P, Dillon JF. Reaching mEthadone users Attending Community pHarmacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV). BMJ Open. 2020 Aug 30;10(8):e036501. doi: 10.1136/bmjopen-2019-036501.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Healy, PhD principal investigator
Public Health Wales
Joseph Doyle, PhD principal investigator
Macfarlane Burnet Institute for Medical Research and Public Health
John F Dillon, PhD study director
University of Dundee
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach Pathway and Education-only Pathway in people with Hepatitis C, run by University of Dundee at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: 12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.