Study on the Prevalence of Hepatitis C In a psychiatRic Population (SaPHIR)
|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: NCT04600479|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : October 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Diagnostic Test: Evaluation of the prevalence of HCV, HBV and HIV viral infections||Not Applicable|
Participation in the SaPHIR study will be offered to patients admitted to one of the inpatient or outpatient adult psychiatric units of the hospitals participating in the study (around Nantes), provided that the realization of the RDTs will be possible.
- Cross-sectional assessment of prevalence : evaluation of the prevalence of HCV, HBV and HIV viral infections All patients admitted to one of the inpatient or outpatient adult psychiatric units of the hospitals participating in the study, whatever the psychiatric diagnosis and without age limit, may be included in the study, provided that the realization of the RDTs will be possible. Only patients who will accept the realization of the HCV RDT will be included, in order to be able to respond to the primary objective of the study. The agreement to realize the two other RDTs is optional. However, for patients who already had a HCV serology performed less than 3 months before inclusion, the HCV RDT will not be performed and the data collected for the study will be based on the previous serology.
- Cohort follow-up of HCV positive patients : evaluation of care pathway and barriers to care for hepatitis C 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||796 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on the Prevalence of Hepatitis C In a psychiatRic Population|
|Estimated Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
Experimental: prevalence and follow-up of HCV positive patients
Diagnostic Test: Evaluation of the prevalence of HCV, HBV and HIV viral infections
- Estimation of the prevalence of chronic hepatitis C in a psychiatric population [ Time Frame: 33 months ]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.
- Effectiveness of the care pathway of the HCV-infected patient [ Time Frame: 33 months ]Percentage of patients who accepted the RDT screening Percentage of patients screened positive Percentage of patients who accepted venous sampling to achieve the C viral load Percentage of patients diagnosed positive by carrying out the C viral load Percentage of patients (diagnosed as positive) having started a care procedure Percentage of patients referred to specialists Percentage of compliant patients Percentage of patients considered cured 12 weeks after the end of treatment
- Prevalence of hepatitis C in a psychiatric population (cured hepatitis and chronic active hepatitis) [ Time Frame: 33 months ]The estimate of the prevalence of hepatitis C will be based on the percentage of patients with positive screening by RDT (anti-HCV Ab), among all the patients included in the study.
- Prevalence of active hepatitis B in a psychiatric population [ Time Frame: 33 months ]The estimate of the prevalence of active hepatitis B will be based on the percentage of patients with positive screening by RDT (HBs Ag), among all patients included in the study. The percentage of patients with a confirmation of the diagnosis of hepatitis B by B viral load (PCR) on venous blood will also be documented.
- Prevalence of HIV in a psychiatric population [ Time Frame: 33 months ]The estimate of the prevalence of HIV infection will be based on the percentage of patients screened by RDT (recombinant proteins gp41 / gp 46), among all patients included in the study. The percentage of patients with a confirmation of the diagnosis of HIV infection by HIV screening (combined anti-HIV1, anti-HIV2 and anti-HIV P24 (HIV1)) on venous blood will also be documented.
- Prevalence of HCV-HBV-HIV co-infections in a psychiatric population [ Time Frame: 33 months ]The estimate of the prevalence of HIV-HCV-HBV co-infections will be based on the percentages of patients co-infected with VHC-VHB, VHC-VIH, VIH-VHB or VHC-VHB-VIH, among all patients included in the study.
- Prevalence of hepatitis C in the sub-population of IDU patients [ Time Frame: 33 months ]The estimate of the prevalence of hepatitis C in the sub-population of IDU will be based on the percentages of IDU patients with positive screening by RDT (anti-HCV ab), among all the patients included in the study.
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): NCT04600479
|Contact: Marie Grall Bronnec||(0)2 40 84 61 16 ext +firstname.lastname@example.org|
|Contact: Gaëlle Challet||(0)188.8.131.52.20 ext +email@example.com|