Hepatitis CSaPHIRNCT04600479
Study on the Prevalence of Hepatitis C In a psychiatRic Population
A study testing Evaluation of the prevalence of HCV, HBV and HIV viral infections in people with Hepatitis C, run by Nantes University Hospital at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Evaluation of the prevalence of HCV, HBV and HIV viral infections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Nov 2020to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHS de Blain
Blain
CH Georges Daumézon
Bouguenais
CHU Nantes
Nantes, 44093
About this study
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.
Read the detailed description
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.
- Conditions
- Hepatitis C
- Being tested
- Evaluation of the prevalence of HCV, HBV and HIV viral infections
- Keywords
- Hepatitis C, psychiatry, Hepatitis B, HIV, care pathway
- Medical subject headings
- Hepatitis C, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the prevalence of HCV, HBV and HIV viral infectionsDiagnostic test
- 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.
- Evaluation of care pathway and barriers to care for hepatitis C. Only patients with positive HCV RDT participating in this follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Evaluation of the prevalence of HCV, HBV and HIV viral infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 33 months
Secondary outcomes (6)
Effectiveness of the care pathway of the HCV-infected patient
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
Measured: 33 months
Prevalence of hepatitis C in a psychiatric population (cured hepatitis and chronic active hepatitis)
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.
Measured: 33 months
Prevalence of active hepatitis B in a psychiatric population
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.
Measured: 33 months
Prevalence of HIV in a psychiatric population
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.
Measured: 33 months
Prevalence of HCV-HBV-HIV co-infections in a psychiatric population
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.
Measured: 33 months
Prevalence of hepatitis C in the sub-population of IDU patients
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.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start26 Nov 2020
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600479
- Sponsor's protocol ID
- RC20_0022
- Acronym
- SaPHIR
- Status last verified
- Apr 2023
- First submitted
- 19 Oct 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prevalence of Hepatitis C In a psychiatRic Population
- ClinicalTrials.gov ID
- NCT04600479
- Acronym / sponsor ID
- SaPHIR / RC20_0022
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, psychiatry, Hepatitis B, HIV, care pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prevalence and follow-up of HCV positive patients | Experimental | Diagnostic Test: Evaluation of the prevalence of HCV, HBV and HIV viral infections1. 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Cross-sectional assessment of prevalence
- 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.
Key exclusion criteria (8 listed)
- Cross-sectional assessment of prevalence:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the prevalence of HCV, HBV and HIV viral infections1. 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. | Diagnostic test | prevalence and follow-up of HCV positive patients |
Primary outcome
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.
6 secondary outcomes
Effectiveness of the care pathway of the HCV-infected patient
Time frame: 33 months
Prevalence of hepatitis C in a psychiatric population (cured hepatitis and chronic active hepatitis)
Time frame: 33 months
Prevalence of active hepatitis B in a psychiatric population
Time frame: 33 months
Prevalence of HIV in a psychiatric population
Time frame: 33 months
Prevalence of HCV-HBV-HIV co-infections in a psychiatric population
Time frame: 33 months
Prevalence of hepatitis C in the sub-population of IDU patients
Time frame: 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the prevalence of HCV, HBV and HIV viral infections in people with Hepatitis C, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the prevalence of chronic hepatitis C in a psychiatric population (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.