Hepatitis C Clinical Trial
— dHEPassOfficial title:
Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital
A high number of people are infected by viral hepatitises B and C without knowing it, especially vulnerable population such as the ones who come in consultation in continuous health care access center (Permanence d'accès aux soins, PASS). Now that these infections can be rapidly treated, it is essential to diagnose them the quickest possible. The Identification and Diagnostic Orientation Test (Test de repérage et d'orientation diagnostique, TROD) technique is a rapid tool allowing to screen for hepatitis B and C by a simple capillary sample. The study aims to evaluate the accptability of a systematic screening using TROD for hepatitis B and C in adults in a PASS consultation in Montpellier. We also want to estimate the prevalence of theses infections in the population, to describe the HBV and HCV care cascades, to evaluate the acceptability of vaccinal catch-up for HBV, and to describe people with hepatits.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | October 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People of 18 years old and more - Non objection to be a participant of the study Exclusion Criteria: - Exclusion period determined by a previous study - Judicial protection (sauvegarde de justice, tutelle or curatelle) - Impossibility of offering clear information to the subject |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier, St Eloi Hospital, | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Gilead Sciences |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of performed TROD | Proportion of performed TROD out on the number of people it has been offered. | Inclusion visit | |
Secondary | Prevalence of hepatits B in the population | Number of positive TROD for hepatitis B out on the number of people with a performed TROD | Inclusion visit | |
Secondary | Prevalence of hepatits C in the population | Number of positive TROD for hepatitis C out on the number of people with a performed TROD. | Inclusion visit | |
Secondary | Care Cascade for HBV | Number of people with positive AgHBs, number of AgHBs+ people knowing their status, number fo AgHBs+ people treated, number of AgHBs+ people treated with an indetectable viral load or significative diminution | 3 months | |
Secondary | Care Cascade for HCV | Number of people with TROD VHC+, number of people knowing their VHC+ status, number of people with VHC ARN, number of treated people with VHC ARN, Numberof people with undetectable VHC ARN 12 weeks after the hepatitis antiviral treatment ending related to the number of people treated with hepatitis C antiviral treatment. | 6 months | |
Secondary | Age | Year of birth is collected. Age is calculed as the difference between the the year of inclusion visit and the year of birth.the serological status, actual medication. | Inclusion visit | |
Secondary | Sex | Male, Female or undetermined. | Inclusion visit | |
Secondary | Social care access | Access to social care is asked : Yes/No. If yes, the participant can precise his social security and complementary health insurance statuses. | Inclusion visit | |
Secondary | Housing status | Permanent housing/ Temporary housing / Homelessness asked by the investigator.. | Inclusion visit | |
Secondary | Life location in the last 6 months | France / Eastern Europe / Russia and ex-USSR / Africa (multiple answers possible). | Inclusion visit | |
Secondary | Smoking status of people | Non-smoker / Former smoker / Actual smoker. | Inclusion visit | |
Secondary | Alcohol high use | More than 10 glasses a week : Yes/no. | Inclusion visit | |
Secondary | Usage of a care facility in Montpellier in the last year | Yes/No. | Inclusion visit | |
Secondary | Knowing of the serological status | Last known serological status for hepatitis B | Inclusion visit | |
Secondary | Knowing of the serological status | Last known serological status for hepatitis C. | Inclusion visit | |
Secondary | Weight of people with hepatitis | Weight in kilograms. | Inclusion visit | |
Secondary | Height of people with hepatitis | Height in centimeters. | Inclusion visit | |
Secondary | Cardiac frequency of people with hepatitis. | In beats per minutes. | Inclusion visit | |
Secondary | Blood pressure of people with hepatitis | Systolic blood pressure measured in mmHg. | Inclusion visit | |
Secondary | Blood pressure of people with hepatitis | Diastolic blood pressure measured in mmHg. | Inclusion visit | |
Secondary | Signs of hepatocellular insuffisance of people with hepatitis. | Yes/No. Determined by the investigator. | Inclusion visit | |
Secondary | Signs of portal hyperpressure of people with hepatitis. | Yes/No. Determined by the investigator. | Inclusion visit |
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