An interventional study of Reach Pathway and Education-only Pathway in Hepatitis C, sponsored by University of Dundee. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of Dundee · Not applicable, Interventional, and Treatment
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.
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.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's enrollment of 1,410 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Dundee is the lead sponsor of 113 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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 other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Reach 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: Education-only 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.
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.
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).
Time frame: 12 weeks after participants finish their hepatitis C treatment, up to 14 weeks from Baseline.
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).
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.
Percentage of patients being tested for HCV in each arm
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
Number of Participants Tested for HCV
Count of number of eligible participants tested for HCV
Time frame: 16 months
Number of Participants Treated for HCV
Number of eligible participants treated for HCV
Time frame: 12 months
Number of Participants Achieved SVR
Number of eligible participants who achieved SVR (cured of HCV infection)
Time frame: 12 weeks after end of treatment
At pharmacies participating in the trial, there were 1,410 clients in receipt of opioid agonist therapy at baseline.
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 762 | 648 |
| Completed | 762 | 648 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 387 | 267 |
| Completed | 387 | 267 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 168 | 133 |
| Completed | 168 | 133 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 148 | 62 |
| Completed | 148 | 62 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 144 | 17 |
| Completed | 144 | 17 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 23 | 6 |
| Completed | 23 | 6 |
| Not completed | 0 | 0 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 22 | 5 |
| Completed | 19 | 4 |
| Not completed | 3 | 1 |
| Milestone | Reach Pathway | Education-only Pathway |
|---|---|---|
| Started | 18 | 2 |
| Completed | 18 | 2 |
| Not completed | 0 | 0 |
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).
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| SVR12 | 18 | 2 |
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).
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| 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. | 18 | 02 |
Percentage of patients being tested for HCV in each arm
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| Determine Whether the REACH Pathway Compared With the Education-only Pathway Leads to More People on Opiate Substitution Therapy Being Tested for HCV. | 144 | 17 |
Percentage of patients adhering to therapy in each arm (taking ≥ 85% of prescribed tablets) as reported in the observed therapy adherence log.
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| Compare Adherence and Persistence to HCV Therapy in the Reach Pathway to the Education-only Pathway. | 19 | 4 |
Percentage of patients in whom changes in therapy are advised due to blood test results, as recorded at start of HCV therapy.
| Participants | Reach Pathway (Treatment Initiators) | Education-only Pathway (Treatment Initiators) |
|---|---|---|
| Assess the Impact of Baseline Blood Tests on Treatment Decisions. | 4 | 1 |
Count of number of eligible participants tested for HCV
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| Number of Participants Tested for HCV | 144 | 17 |
Number of eligible participants treated for HCV
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| Number of Participants Treated for HCV | 22 | 5 |
Number of eligible participants who achieved SVR (cured of HCV infection)
| Participants | Reach Pathway | Education-only Pathway |
|---|---|---|
| Number of Participants Achieved SVR | 18 | 2 |
Collected over From date of consent to maximum 30 days following paricipant's final study visit/study exit date.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reach Pathway (Consented to Test) | 0/148 (0%) | 1/148 (0.7%) | 5/148 (3.4%) |
| Education-only Pathway (Consented to Test) | 0/62 (0%) | 0/62 (0%) | 2/62 (3.2%) |
| Event | Reach Pathway (Consented to Test) | Education-only Pathway (Consented to Test) |
|---|---|---|
| Recreational drug overdoseInjury, poisoning and procedural complications | 1/148 | 0/62 |
| Event | Reach Pathway (Consented to Test) | Education-only Pathway (Consented to Test) |
|---|---|---|
| Pyrexia of unknown origin.Immune system disorders | 0/148 | 1/62 |
| Back pain secondary to fall from bicycle.General disorders | 0/148 | 1/62 |
| Bilateral radial wrist fractures secondary to fall.Musculoskeletal and connective tissue disorders | 1/148 | 0/62 |
| Psychosis in the background of increasing paranoia and delusions; secondary to drug misuse.Psychiatric disorders | 1/148 | 0/62 |
| Cellulitis left lower leg.Infections and infestations | 1/148 | 0/62 |
| Right Leg deep vein thrombosis.Vascular disorders | 1/148 | 0/62 |
| Assault: multiple wounds left side of faceSocial circumstances | 1/148 | 0/62 |
Baseline trial data were only collected from participants who agreed to a HCV test, this was part of the design of the study and a purposeful choice.
| Age, Continuous(years) | Consented Population REACH Pathway | Consented Population Education-Only Pathway | Total |
|---|---|---|---|
| Median | 42.1 ± 8.5 | 43.7 ± 9.8 | 42.6 ± 8.9 |
| Sex: Female, Male(Participants) | Consented Population REACH Pathway | Consented Population Education-Only Pathway | Total |
|---|---|---|---|
| Female | 52 | 21 | 73 |
| Male | 96 | 41 | 137 |
| Race and Ethnicity Not Collected(Participants) | Consented Population REACH Pathway | Consented Population Education-Only Pathway | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Post-publication of final results for a period of 3 years.
Access criteria: Researchers who supply a methodologically sound proposal.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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