NCT03513796

Brief Summary

EVERYONES HCV is a retrospective review of all previous Hepatitis C (HCV) testing and diagnosis in NHS Tayside. The aim of this study is to analyse and compare the different Hepatitis C diagnostic pathways with a view to determining the most cost effective combination of methods of diagnosing HCV infection in a typical developed world population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,949

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 27, 2018

Last Update Submit

March 5, 2021

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Number of HCV tests processed in NHS Tayside between 1999 and 2017

    Total number of HCV IgG and PCR tests processed by NHS Tayside Virology lab between 1999 and 2017

    16 months

Secondary Outcomes (3)

  • Number of HCV tests that are positive in NHS Tayside between 1999 and 2017

    16 months

  • Number of positive HCV tests by requesting source between 1999 and 2017

    16 months

  • Cost of HCV testing in each requesting healthcare environment.

    16 months

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All individuals in NHS Tayside tested for Hepatitis C (HCV) between 1st January 1999 and 31st January 2018

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Tayside

Dundee, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Dillon, MD

    University of Dundee and NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

May 2, 2018

Study Start

June 20, 2018

Primary Completion

December 31, 2018

Study Completion

February 16, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)