Hepatitis CSuperDOT-CNCT02706223
Testing and Treating Hepatitis C in Community Pharmacies
A study testing Pharmacist Led and Nurse led in people with Hepatitis C, run by University of Dundee at 3 sites in United Kingdom.
Trial summary
Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pharmacist Led and Nurse led
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HCV PCR positive,
- Stable OST dose for greater than 12 weeks prior to study enrolment
Who cannot join
- Evidence of current or previous decompensated liver disease,
- Currently receiving HCV eradication treatment
- HIV infection,
- HBsAg positive with detectable HBV DNA,
- Pregnancy
- Cirrhosis or high fibrosis score
- Genotype deemed unsuitable for treatment with available study drugs
- Unable or unwilling to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
NHS Grampian
Aberdeen, AB25 2ZN
NHS Tayside
Dundee, DD1 9SY
NHS Greater Glasgow and Clyde
Glasgow, G$ 0SF
About this study
Official title: A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland
Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers.
The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff.
Read more
Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy.
The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.
Read the detailed description
The SuperDOT-C study will evaluate a new pathway of care for patients on OST who are already receiving OST therapy on a daily basis from a pharmacist. Newer therapies for HCV have recently become much simpler to initiate and supervise with much improved effectiveness and as described below it is now proposed to extend the role of community pharmacists into initiating HCV therapy alongside the existing OST The SuperDOT-C study will utilise this existing environment and relationship to smooth the pathway into HCV therapy with co-administration of OST alongside the anti-HCV therapy under the supervision of the pharmacist compared with the established pathway of referral to another site and treatment with a nurse led ant-HCV treatment program. This new pathway may have positive effects on the movement towards HCV cure at multiple levels. The planned pathway is different to current care at each point, from testing and diagnosis through adherence to cure. In the planned pathway, the patient interacts with the pharmacist on a daily basis, as compared to intermittent interaction with a secondary care team member. The result being that the patient has a shorter care pathway, with less travelling and better access to anti-HCV treatment. The daily interaction with the pharmacy provides opportunities to assess and support the patient, provide sound advice and care, with the added benefit of being able to directly observe treatment, (DOT), thus potentially improving adherence.
- Conditions
- Hepatitis C
- Being tested
- Pharmacist Led, Nurse led
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist LedOther
Trial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects
Nurse ledOther
Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Led | Experimental | This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists Receives: Other: Pharmacist Led |
| Nurse Led | Experimental | This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses Receives: Other: Nurse led |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy
Blood test result; PCR - based measurement of levels of hepatitis C virus.
Measured: 12 week SVR, (12 weeks post completion of HCV treatment)
Secondary outcomes (6)
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
Health economics analysis
Measured: Span of study ie 24 months
To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment
Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway
Measured: Span of study ie 24 months
To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway
Comparison of compliance rates of antiviral medications between pharmacist and conventional pathway.
Measured: Span of study ie 24 months
To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients
Compare the acceptability of the pharmacist pathway as compare to conventional pathway of care
Measured: Span of study ie 24 months
To measure re-infection rate at 1 year after end of treatment in patients with SVR
Comparison of the rate of reinfections with HCV between pharmacist and conventional pathways
Measured: Span of study ie 24 months
To compare the number of patients who drop out of the study between the two pathways
Comparison of subject drop out rates between pharmacist and conventional pathways
Measured: Span of study ie 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F Dillon, MD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706223
- Sponsor's protocol ID
- 2014GA07
- Acronym
- SuperDOT-C
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Radley A, de Bruin M, Inglis SK, Donnan PT, Hapca A, Barclay ST, Fraser A, Dillon JF. Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):809-818. doi: 10.1016/S2468-1253(20)30120-5. Epub 2020 Jun 8.
PubMed 32526210Hickman M, Dillon JF, Elliott L, De Angelis D, Vickerman P, Foster G, Donnan P, Eriksen A, Flowers P, Goldberg D, Hollingworth W, Ijaz S, Liddell D, Mandal S, Martin N, Beer LJZ, Drysdale K, Fraser H, Glass R, Graham L, Gunson RN, Hamilton E, Harris H, Harris M, Harris R, Heinsbroek E, Hope V, Horwood J, Inglis SK, Innes H, Lane A, Meadows J, McAuley A, Metcalfe C, Migchelsen S, Murray A, Myring G, Palmateer NE, Presanis A, Radley A, Ramsay M, Samartsidis P, Simmons R, Sinka K, Vojt G, Ward Z, Whiteley D, Yeung A, Hutchinson SJ. Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol). BMJ Open. 2019 Sep 24;9(9):e029538. doi: 10.1136/bmjopen-2019-029538.
PubMed 31551376Radley A, de Bruin M, Inglis SK, Donnan PT, Dillon JF. Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy: a study protocol for a pragmatic cluster randomised trial. BMJ Open. 2018 Dec 14;8(12):e021443. doi: 10.1136/bmjopen-2017-021443.
PubMed 30552244
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland
- ClinicalTrials.gov ID
- NCT02706223
- Acronym / sponsor ID
- SuperDOT-C / 2014GA07
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
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), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers.
The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff.
Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy.
The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.
Detailed description
The SuperDOT-C study will evaluate a new pathway of care for patients on OST who are already receiving OST therapy on a daily basis from a pharmacist. Newer therapies for HCV have recently become much simpler to initiate and supervise with much improved effectiveness and as described below it is now proposed to extend the role of community pharmacists into initiating HCV therapy alongside the existing OST The SuperDOT-C study will utilise this existing environment and relationship to smooth the pathway into HCV therapy with co-administration of OST alongside the anti-HCV therapy under the supervision of the pharmacist compared with the established pathway of referral to another site and treatment with a nurse led ant-HCV treatment program. This new pathway may have positive effects on the movement towards HCV cure at multiple levels. The planned pathway is different to current care at each point, from testing and diagnosis through adherence to cure. In the planned pathway, the patient interacts with the pharmacist on a daily basis, as compared to intermittent interaction with a secondary care team member. The result being that the patient has a shorter care pathway, with less travelling and better access to anti-HCV treatment. The daily interaction with the pharmacy provides opportunities to assess and support the patient, provide sound advice and care, with the added benefit of being able to directly observe treatment, (DOT), thus potentially improving adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Led | Experimental | Other: Pharmacist LedThis arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists |
| Nurse Led | Experimental | Other: Nurse ledThis arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HCV PCR positive,
- Stable OST dose for greater than 12 weeks prior to study enrolment
Key exclusion criteria (8 listed)
- Evidence of current or previous decompensated liver disease,
- Currently receiving HCV eradication treatment
- HIV infection,
- HBsAg positive with detectable HBV DNA,
- Pregnancy
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 |
|---|---|---|
| Pharmacist LedTrial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects | Other | Pharmacist Led |
| Nurse ledTrial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses | Other | Nurse Led |
Primary outcome
Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy
Time frame: 12 week SVR, (12 weeks post completion of HCV treatment)
Blood test result; PCR - based measurement of levels of hepatitis C virus.
6 secondary outcomes
Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
Time frame: Span of study ie 24 months
To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment
Time frame: Span of study ie 24 months
To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway
Time frame: Span of study ie 24 months
To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients
Time frame: Span of study ie 24 months
To measure re-infection rate at 1 year after end of treatment in patients with SVR
Time frame: Span of study ie 24 months
To compare the number of patients who drop out of the study between the two pathways
Time frame: Span of study ie 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Derived from this study: PubMed 32526210Radley A, de Bruin M, Inglis SK, Donnan PT, Hapca A, Barclay ST, Fraser A, Dillon JF. Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):809-818. doi: 10.1016/S2468-1253(20)30120-5. Epub 2020 Jun 8.
- Derived from this study: PubMed 31551376Hickman M, Dillon JF, Elliott L, De Angelis D, Vickerman P, Foster G, Donnan P, Eriksen A, Flowers P, Goldberg D, Hollingworth W, Ijaz S, Liddell D, Mandal S, Martin N, Beer LJZ, Drysdale K, Fraser H, Glass R, Graham L, Gunson RN, Hamilton E, Harris H, Harris M, Harris R, Heinsbroek E, Hope V, Horwood J, Inglis SK, Innes H, Lane A, Meadows J, McAuley A, Metcalfe C, Migchelsen S, Murray A, Myring G, Palmateer NE, Presanis A, Radley A, Ramsay M, Samartsidis P, Simmons R, Sinka K, Vojt G, Ward Z, Whiteley D, Yeung A, Hutchinson SJ. Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol). BMJ Open. 2019 Sep 24;9(9):e029538. doi: 10.1136/bmjopen-2019-029538.
- Derived from this study: PubMed 30552244Radley A, de Bruin M, Inglis SK, Donnan PT, Dillon JF. Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy: a study protocol for a pragmatic cluster randomised trial. BMJ Open. 2018 Dec 14;8(12):e021443. doi: 10.1136/bmjopen-2017-021443.
- Individual participant dataSharing planned: Undecided
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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.
John F Dillon, MD principal investigator
University of Dundee
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Led and Nurse led in people with Hepatitis C, run by University of Dundee at 3 sites in United Kingdom.
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 2 inclusion and 8 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 30 Aug 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy (time frame: 12 week SVR, (12 weeks post completion of HCV treatment)). 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 NCT02706223, which also lists 3 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 30 Aug 2019.