Study on the Prevalence of Hepatitis C In a psychiatRic Population

NCT04600479 | Completed

• 1 other identifier: RC20_0022
• Study Type: interventional
• Target: 796
• Locations: 1 country
• Sites: 3

Brief Summary

Viral hepatitis, especially hepatitis C, is a major public health issue. Nowadays, very few studies in France have evaluated the prevalence of hepatitis C in a psychiatric environment. In 2019, at the time of new treatments for HCV, it therefore seems essential to update the available data by estimating the prevalence of chronic active hepatitis C in psychiatric population. In addition to an update of epidemiological data, it is of high importance to assess the effectiveness of the care pathway for patients in whom chronic active hepatitis C is diagnosed, including the cascade of care, currently too inefficient despite treatments that are themselves ultra-efficient. Indeed, it is essential that once hepatitis is detected, it is formally diagnosed, then that the patient actually starts care and is adherent to treatment (take his treatment according to the prescription and until the end: this implies that the patient accepts his or her illness and understands the value of the prescribed treatments), to hope to cure the infection. In this context, the SaPHIR study will allow to test a systematic screening of patients in an adult psychiatric environment, through rapid diagnostic tests (RDT). The objective is to promote the adherence of patients, and to assess possible obstacles in order to optimize the screening (RDTs), diagnosis (confirmation of only positive RDTs by venous sampling) and care management circuits in routine practice. In addition, the study envisages a combined HCV-HBV-HIV screening, taking into account the cross-infection risk (same mode of contamination, same risk population, frequent co-infections, more severe liver pathology in case of co-infection, etc.), thus making it possible to take care of the patient as a whole. The results of the SaPHIR study can ultimately be sent to the French health authorities to improve screening and care circuits, and their coverage by social security.

Conditions

Hepatitis C

Keywords

Hepatitis C; psychiatry; Hepatitis B; HIV; care pathway

Outcome Measures

Primary Outcomes (1)

• Estimation of the prevalence of chronic hepatitis C in a psychiatric population

  The prevalence estimate will be based on the percentage of patients in whom the viral C RNA is detected (greater than 15 IU / mL) in venous blood by the polymerase chain reaction (PCR) technique, among the patients admitted to one of the inpatient or outpatient adult psychiatric units of the hospitals participating in the study (around Nantes). The viral C RNA will be considered undetected in the case of a negative HCV RDT screening.

  33 months

Secondary Outcomes (6)

• Effectiveness of the care pathway of the HCV-infected patient

  33 months

• Prevalence of hepatitis C in a psychiatric population (cured hepatitis and chronic active hepatitis)

  33 months

• Prevalence of active hepatitis B in a psychiatric population

  33 months

• Prevalence of HIV in a psychiatric population

  33 months

• Prevalence of HCV-HBV-HIV co-infections in a psychiatric population

  33 months

Study Arms (1)

prevalence and follow-up of HCV positive patients

EXPERIMENTAL

1. Cross-sectional assessment of prevalence : evaluation of the prevalence of HCV, HBV and HIV viral infections 2. Cohort follow-up of HCV positive patients : evaluation of care pathway and barriers to care for hepatitis C

Diagnostic Test: Evaluation of the prevalence of HCV, HBV and HIV viral infections

Interventions

Evaluation of the prevalence of HCV, HBV and HIV viral infections DIAGNOSTIC_TEST

1. Assessment of prevalence HCV, HBV and HIV prevalence estimations. Sociodemographic and clinical data will be collected from the patient's medical record and through self-questionnaires completed by the patient. A systematic screening by 3 RDTs (HCV, HBV and HIV) will be proposed in the specific framework of the SaPHIR study.This is a screening performed on capillary blood (TOYO VHC ®, TOYO VHB ® and INSTI HIV 1 / HIV 2 ®), to obtain a result in less than 30 minutes. In case of confirmation of the diagnosis of viral hepatitis or HIV infection, the final result will be transmitted and explained to the patient by the referring doctor, who will organize the adapted care pathway and prescribe the DAA for the simple patients. The complex patients will be referred to the specialist to consider starting an appropriate treatment. 2. Evaluation of care pathway and barriers to care for hepatitis C. Only patients with positive HCV RDT participating in this follow-up.

prevalence and follow-up of HCV positive patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cross-sectional assessment of prevalence
• Patients with all the following characteristics can be included:
• Patient admitted to one of the inpatient or outpatient adult psychiatric units of the hospitals participating in the study
• Patient accepting the realization of the HCV RDT (or patient with positive HCV serology performed less than 3 month ago)
• Cohort follow-up of HCV positive patients:
• Patients who are included in the cross-sectional assessment of prevalence of the SaPHIR study and having a positive HCV RDT (or positive HCV serology performed less than 3 months ago) will participate in the follow-up of the study.

You may not qualify if:

• Cross-sectional assessment of prevalence:
• Patients with at least one of the following characteristics cannot be included:
• Minors under 15 years of age (all units involved in the recruitment are adult psychiatry units, for which the minimum age limit is 15 years and 3 months);
• Pregnant or lactating woman;
• Participating simultaneously in another interventional research on a drug (so as not to interfere with the biological assays);
• Not mastering the reading and writing of the French language well enough.
• Patient placed under judicial protection
• Cohort follow-up of HCV positive patients Patients who are included in the cross-sectional assessment of prevalence of the SaPHIR study, with negative RDT HCV (or negative HCV serology performed less than 3 months ago) cannot participate in the follow-up of the study.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHS de Blain

Blain, France

Location

CH Georges Daumézon

Bouguenais, France

Location

CHU Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis B

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; Hepadnaviridae Infections; DNA Virus Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: November 26, 2020
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

FR (3)