HCV Care Pathway in Ile-de-France (ParcoursVHC)

September 1, 2016 updated by: Assistance Publique - Hôpitaux de Paris
The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The current estimation of infected persons with chronic hepatitis C in France is over 200 ,000. It appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. Indeed, these new HCV infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (MSM) and who are supported too late and without real access to treatment.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients newly screened positive for HCV among private practitioners, screening and diagnostic centers, precarious consultations addictology structures, associations of patients or medical units detention centers.

Patients already diagnosed positive for HCV but not monitored in a care sector will also be included in the pathway

Description

Inclusion Criteria:

  • 18 years old and more
  • Positive Hepatitis C virus
  • Patient having expressed a non-objection to participate in this research

Exclusion Criteria: None

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Population at Risk
Population with at least one risk factor of being infected with hepatitis C; MSM population; people in precarious situations and / or attending support from addictions care structures.
Other: No intervention
Prison population
Proposal of participation to a " consultation arrivants " by the staff of medical units correctional
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients effectively cared divided by number of patients eligible to care.
Time Frame: Year 3
Year 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients cared in the HCV care pathway in Ile-de-France
Time Frame: Year 3
Year 3
Number of patients effectively treated divided by number of patients eligible to DAA treatment.
Time Frame: Year 3
Year 3
Delay between HCV diagnosis and early consultation
Time Frame: Year 3
Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Stéphanie DOMINGUEZ, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RARS 28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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