Completed

Evaluation of Multiple HCV Diagnosis Pathways for Efficacy, Cost Effectiveness and Cure, in a Regionally Defined General Population

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

Over 16 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: June 2018
See protocol details

Summary

Principal SponsorNHS Tayside
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2018

Actual date on which the first participant was enrolled.

Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. The "serious and significant public health risk" posed by HCV was recognised during a member's debate in the Scottish Parliament in 2004. By December 2006, Health Protection Scotland estimated that 50,000 persons in Scotland had been infected with the Hepatitis C virus and that 38,000 were chronic carriers. Currently, the greatest risk of acquiring the virus in the UK is through injecting drug use. In Scotland, it is estimated that over 85% of individuals who have Hepatitis C were infected in this way. Scotland has taken the lead within the UK in tackling HCV with its Hepatitis C Action Plan. One of the plan's key goals was to identify undiagnosed infections. The plan has identified that access to testing was a significant obstacle in diagnosis. Nearly 75% of undiagnosed cases of HCV within Scotland (16,300) are people who inject drugs (PWIDs) who no longer inject. Given that we have now entered the new era of the curative direct antiviral agents against HCV, it is important that we develop new stratagems to identify and treat those cases The investigators had considered population screening, however this is not justified under World Health Organisation (WHO) criteria due to the relatively low prevalence in Scotland. The way forward will be to prioritise strategies and target different population groups in a logical manner. The question is what is the most cost-effective means to achieve this and with what combination of testing strategies. Tayside has been at the forefront of piloting novel testing methods. The following list includes the current diagnostic pathways which are standard care in NHS Tayside and previously published pilot studies. 1. Standard diagnosis pathway: clinical suspicion at presentation in primary (pathway 1a) or secondary care (pathway 1b) that HCV could be the cause of the presentation or co-incident issue requiring testing 2. Patients on opiate substitution therapy (OST): testing is being done across the Tayside Substance Misuse Services on initial assessment and annually thereafter. 3. Patients on opiate substitution therapy (OST). Opportunistic testing done for clients receiving OST in participating dispensing pharmacies. 4. Testing in needle exchanges 5. Patients previously on OST or in drug treatment: review of methadone prescription records, dating back to the 1980s, to identify patients at increased risk of HCV 6. Prisons: opt-out testing upon entry is standard practice for all prisoners in the region 7. Community outreach to ethnic minorities, including testing in the mosques 8. General Practice: Electronic record trawl and health promotion 1. Record trawl with specially designed search tools to identify patients at increased risk of HCV infection and GP follow up offer of testing. 2. Health promotion message and easy access HCV testing for selected general practices in Tayside. 9. Targeted General Practice screening in Glasgow: 1. Targeting to GPs in areas with high social deprivation, as these are associated with higher HCV prevalence 2. Targeting to GPs with in areas with high social deprivation, with patients who have a history of IVDU and fall within the ages of 30-64 10. GP record unification. 24 general practices in Tayside unified their HCV testing records with the secondary care HCV records to identify patients never referred or lost to follow up. Whilst this is not a novel diagnosis pathway, the outcomes will provide important information regarding linkage to care for other pathways. The investigators intend to retrospectively compare and evaluate the existing and pilot studies that have been conducted in NHS Tayside along with two general practice based studies from Glasgow to determine the optimum and most cost effective bundle of diagnostic activities to bring the different HCV communities to diagnosis and accessing of treatment.

Official TitleEvaluation of Multiple HCV Diagnosis Pathways for Efficacy, Cost Effectiveness and Cure, in a Regionally Defined General Population
NCT03513796
Principal SponsorNHS Tayside
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1949 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, ChronicHepatitis, Viral, HumanHepatitis CInfectionsLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsHepatitis C, ChronicDisease Attributes

Criteria

1 inclusion criteria required to participate
All individuals in NHS Tayside tested for Hepatitis C (HCV) between 1st January 1999 and 31st January 2018

1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

NHS Tayside

Dundee, United KingdomOpen NHS Tayside in Google Maps
CompletedOne Study Center