Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/04/2015
Date assigned
24/04/2015
Last edited
01/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hepatitis C is a virus that can infect the liver. Most people do not have any symptoms as they do not arise until the virus has caused significant damage to the liver. When they do occur, they tend to be vague and similar to a number of other conditions. They include flu-like symptoms, feeling tired and depression. People can get infected with the virus if they come into contact with the blood of an infected person, for example, by sharing drug needles. Due to the condition not having any obvious symptoms, regular testing is recommended for people considered to be in a high risk group, for example drug users. Here, we want to see if we can increase testing and diagnosis of people at an increased risk of hepatitis C virus (HCV) infection in the primary care setting (for example, at GP surgeries).

Who can participate?
Patients that have been approached by their GPs for HCV testing and attending a participating GP practice.

What does the study involve?
Participating GP practices are randomly allocated into one of two groups. Those in group one are given a complex intervention (or programme) consisting mainly of targeted case finding and inviting high risk patients to the practice for a test. Those in group two are not given the intervention and carry on as usual. We also look at how acceptable both patients and health care providers find the intervention and identify potential modifications that may be required to encourage HCV testing in primary care. At the end of the study we compare HCV testing, diagnosis, assessment and treatment rates between intervention and control sites. If the interventions are acceptable, work well and cost-effective then we will encourage their roll-out in primary care.

What are the possible benefits and risks of participating?
Some high risk HCV patients registered at the intervention practices may be given an earlier test or diagnosis as a result of the practice being involved in the study. For the participants involved in the qualitative study, although there may not be any direct benefit from taking part, they will be helping to improve future services and treatment accessibility for people living with HCV. We do not foresee any potential risks to the patients. For the qualitative interviews, the only risk we foresee is related to patient inconvenience related to consent procedures and participation in the interviews.

Where is the study run from?
Primary care practices in the South West of England (UK)

When is the study starting and how long is it expected to run for?
June 2015 to December 2016

Who is funding the study?
Department of Health - National Specialised Commissioning Team (UK)

Who is the main contact?
Dr Kirsty Roberts

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kirsty Roberts

ORCID ID

Contact details

School of Social and Community Medicine
Oakfield House
Oakfield Grove Bristol
Bristol
BS8 2BN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18696

Study information

Scientific title

Evaluation of interventions designed to increase diagnosis and treatment of patients with Hepatitis C virus infection in primary care

Acronym

HepCATT

Study hypothesis

This study will determine whether we can increase testing and diagnosis of individuals at increased risk of HCV infection in primary care with a complex intervention consisting mainly of targeted case finding and inviting high risk patients to the practice for a test. We will also conduct a nested qualitative study with patients and health-care providers to assess the acceptability of the intervention and identify potential modifications that may be required to encourage HCV testing in primary care.

Ethics approval

15/SW/0094

Study design

Randomised; Interventional and Observational; Design type: Diagnosis, Screening, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

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

Condition

Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases

Intervention

HCV test algorithm: The HCV test algorithm will run a search on GP systems to generate a list of individuals with risk markers for HCV infection
1. Increasing patient awareness, displaying Hepatitis C posters and leaflets in the practice waiting rooms
2. Increasing practice awareness
3. An offer of educational training on HCV for practice staff

Intervention type

Other

Phase

Drug names

Primary outcome measures

Number/proportion of patients tested for HCV; Timepoint(s): 12 months

Secondary outcome measures

1. Cost of case finding and testing; Timepoint(s): 12 months
2. Incremental cost per case detected; Timepoint(s): 12 months
3. Number and proportion testing positive (yield); Timepoint(s): 12 months
4. Number/ proportion attending for assessment; Timepoint(s): 12 months
5. Number/ proportion initiating treatment; Timepoint(s): 12 months
6. Number/ proportion referred for specialist assessment; Timepoint(s): 12 months

Overall trial start date

01/07/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

For patient interviews:
1. Individuals approached by their GP for a HCV test in participating intervention practices who are aged over 18 years old
2. Able to provide informed consent and who have a telephone they can be contacted on

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 920; UK Sample Size: 920

Participant exclusion criteria

For the patient interviews:
Unable to provide informed consent

Recruitment start date

01/06/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Primary Care Trust (lead)
Bristol
-
United Kingdom

Trial participating centre

North Somerset Primary Care Trust
Somerset
-
United Kingdom

Trial participating centre

South Gloucestershire Primary Care Trust
Gloucestershire
-
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Department of Health - National Specialised Commissioning Team; Grant Codes: 015/0309

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results of the trial in a peer reviewed journal and at national conferences.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27473371

Publication citations

Additional files

Editorial Notes

01/08/2016: Publication reference added.