HCV Care Pathway in Ile-de-France

NCT02893046 | Unknown

• 1 other identifier: RARS 28
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C Virus

Keywords

care pathway; hospital- private network; early consultation

Outcome Measures

Primary Outcomes (1)

• Number of patients effectively cared divided by number of patients eligible to care.

  Year 3

Secondary Outcomes (3)

• Number of patients cared in the HCV care pathway in Ile-de-France

  Year 3

• Number of patients effectively treated divided by number of patients eligible to DAA treatment.

  Year 3

• Delay between HCV diagnosis and early consultation

  Year 3

Study Arms (2)

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

Interventions

No intervention OTHER

Population at Risk; Prison population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence Regionale de Sante d'Ile de France: collaborator

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Stéphanie DOMINGUEZ, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie DOMINGUEZ, MD

CONTACT

(0)1 49 81 25 26; stephanie.dominguez@aphp.fr

Antoine BACHELARD, MD

CONTACT

(0)1 49 81 25 26; antoine.bachelard2@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2019
• Last Updated: September 8, 2016

Record last verified: 2016-08

Locations

FR (1)