Condition category
Infections and Infestations
Date applied
19/12/2018
Date assigned
24/01/2019
Last edited
25/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
An estimated 200,000 people in the UK have been infected with the Hepatitis C Virus (HCV), which is an important cause of liver disease, cancer and death. Most HCV infections in the UK are in people who inject drugs. New HCV drugs cure over 90% of patients within 12 weeks with few side-effects, but are expensive (over £20,000) and currently restricted to people with moderate or severe liver disease.

Mathematical models suggest that HCV “Treatment as Prevention”, i.e. treating people who inject drugs and have mild liver disease for HCV, can reduce the overall number of new HCV infections in the population, even though some people who inject drugs may also become re-infected. Further, if HCV treatment is increased sufficiently, then HCV will eventually be “eliminated” from the UK population. However, the findings from these models need to be tested out in patients. – This is what we aim to address.

Who can participate?
WS1 and 3: People who are injecting drug users, who have had a diagnosis of HCV are eligible to participate. They must be over the age of 18 years old, able to consent (for example, not intoxicated by alcohol) and not have any mental health or behavioural problems which would affect their participation.

What does the study involve?
WS1: Quantitative: completion of a short questionnaire containing questions on living circumstances and drug use. There are also five questions about how healthy participants feel. The completion of these questionnaires will be completed at the start of treatment, completion of treatment, 12 weeks post treatment and one-year post treatment.

WS3: Qualitative:
Treatment completers: A one-to-one interview with either a peer or academic researcher after completion of treatment.

Treatment refusers: A one-to-one interview with either a peer or academic researcher after refusal of treatment.

Staff: Focus groups, facilitated by academic staff, in the latter stages of up-scaling treatment.

What are the possible benefits and risks of participating?
The study may not benefit participants directly, but it is hoped that the results will help improved the treatment of Hepatitis C within the PWID population.

WS1: Quantitative: There are no anticipated risks associated with completing the short questionnaires. Any side effects of the medication or tests undertaken will be explained fully by the doctor, nurse or pharmacist involved the care of participants, but these are standard risks that are not associated solely with this study.

WS3: Qualitative: Participants may find that talking about their experiences upsetting. If this happens, they will be able to take a break from the interview, after which the researcher will ask if they are prepared to continue. If additional support is required, the researcher can arrange for them to speak to one of the service staff in addition to offering a list of local services that may help.

Where is the study run from?
The research programme is being coordinated in Bristol, with researchers across Scotland and England collaborating on each of the work streams.

Participants for WS1 and 3 are being recruited in Dundee. WS1 is being coordinated from Dundee and WS3 from Glasgow.

When is the study starting and how long is it expected to run for?
The grant started in February 2018. Recruitment and follow-up will continue for two years. WS1-4 will all feed into inform the protocol for WS5, which is scheduled to be completed in 2020.

The programme of research will be completed in 2023.

Who is funding the study?
The study is funded by NIHR.

Who is the main contact?
Jade Meadows, jade.meadows@bristol.ac.uk

Trial website

https://www.bristol.ac.uk/population-health-sciences/projects/epitope/

Contact information

Type

Public

Primary contact

Mrs Jade Meadows

ORCID ID

Contact details

Population Health Sciences
Bristol Medical School
Oakfield House (OF22)
Bristol
BS8 2BN
Bristol
BS8 2BN
United Kingdom
0117 331 3320
jade.meadows@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WS 1 and 3: Sponsor: 1-005-18, R&D:2016GA10

Study information

Scientific title

Evaluating the Population Impact of hepatitis C direct-acting antiviral Treatment as Prevention for people who inject drugs: a non-randomised trial

Acronym

EPIToPe

Study hypothesis

HCV Treatment scale-up for PWID, and resulting HCV Treatment as Prevention (TasP) could enhance other primary interventions and reduce HCV incidence and chronic prevalence to negligible levels (i.e. towards elimination as a major public health concern)

Ethics approval

East of Scotland REC 1, 20/11/2018, ref. 18/ES/0128.

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hepatitis C

Intervention

Work stream (WS) 1: the removal of any restrictions of access to treatment by disease stage and scaling-up treatment in PWID. Treatment of hepatitis C (HCV) will be offered to active drug users across 4 novel treatment pathways: pharmacy, needle exchange services, prisons and drug treatment centres. Participants will be recruited over a one-year period. Participants will be followed up at 12 weeks and one-year post treatment. In addition, to the novel pathways being offered, an up-scale of the numbers being offered treatment is also planned.

WS 5: an increase in HCV treatment for PWID with mild disease as with WS1.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The utility status of HCV infection and the change in utility with treatment and cure will be measured using the EQ5D5L questionnaire at treatment start, treatment end, 12 weeks following end of treatment and one year following treatment.

Secondary outcome measures

1. The experiences and perceptions of service providers will be measured using qualitative interviews and/or focus groups during the latter stages of treatment scale -up during 2018-2019.
2. The experiences and perceptions of individuals undergoing HCV treatment will be measured using qualitative interviews post treatment and around one year later.
3. The experiences and perceptions of individuals refusing HCV treatment will be measured using qualitative interviews once following refusal of treatment.

Overall trial start date

01/02/2018

Overall trial end date

31/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. HCV diagnosis
2. Injecting drug use
3. Aged 18 years or over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

WS1 and 3 : 500

Participant exclusion criteria

1. Mental health or behavioural problems e.g. psychosis, aggressiveness.

Recruitment start date

15/01/2019

Recruitment end date

30/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Tayside
NHS Tayside Address Kings Croos Clepington Road Dundee DD3 8EA SCOTLAND
Dundee
DD3 8EA
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

TASC
Residency Block
Level 3
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Month - Paper
12 Paper_3: Trial methods
18 Draft Paper_8: Chronic HCV 2010-2016
18 Paper_14: Providers perspectives
24 Draft Paper_4: Can rapid scale-up be achieved
24 Draft Paper_7: Health utilities
24 Draft Paper_9: Chronic HCV 2010-2019/20
24 Draft Paper_15: Patient perspectives on TasP
30 Dissemination Event & Draft Paper_18: Manual
33 Draft Paper_27: Progress report
33 Draft Paper_27: Protocol
48 Draft Paper_6: Re-infection rates
56 Draft Paper_13: Addiction outcomes of HCV SVR vs untreated PWID
60 Paper_28: Qualitative insights
60 Paper_29: Evaluation outcomes
60 Paper_30: Cost-effectiveness

IPD sharing statement: our aim is to store data in a publicly available repository, however plans will have to be made for the qualitative and linked data. The data sharing plans for the current study will be made available at a later date.

Intention to publish date

15/02/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/01/2019: Internal review.