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Evaluating Treatment as Prevention Among People Who Inject Drugs in Dundee for HCV (ERAPID HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03356405
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to conduct an evaluation of hepatitis C treatments in NHS Tayside in order to empirically test the "treatment as prevention" models. This will be done by analysing the records of patients who have been tested and treated for hepatitis C using NHS Tayside databases. There will be no interventions carried out as part of this study.

Condition or disease
Hepatitis C Viral

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Evaluating Treatment as Prevention Among People Who Inject Drugs in Dundee for HCV
Anticipated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. The number of HCV positive tests recorded in NHS Tayside. [ Time Frame: 6 years ]
    The number of reactive DBST conducted in NHS Tayside.


Secondary Outcome Measures :
  1. The number of patients engaged in treatment and SVR12 during the treatment phase [ Time Frame: 6 years ]
    The numbers of patients who are treated for HCV and the number who achieve an SVR12.

  2. The cost of treatment [ Time Frame: 6 years ]
    The cost of treating HCV infection in PWID will be measured.

  3. Re-infection with HCV following treatment [ Time Frame: 6 years ]
    Annual routine offer of HCV testing


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All individuals in NHS Tayside eligible for HCV testing and treatment according to Scottish Intercollegiate Guidelines Network guidelines.
Criteria

Inclusion Criteria:

  • All individuals in NHS Tayside eligible for HCV testing and treatment according to Scottish Intercollegiate Guidelines Network guidelines.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356405


Contacts
Contact: Sarah Inglis, PhD 01382 383219 s.k.inglis@dundee.ac.uk
Contact: John Dillon, MD 01382 632176 j.dillon@nhs.net

Locations
United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
More Information

Responsible Party: John Dillon, Professor John Dillon, University of Dundee
ClinicalTrials.gov Identifier: NCT03356405     History of Changes
Other Study ID Numbers: 2016GA08
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases