Hepatitis C in Prison: Study of Screening and Rapid Treatment (HEPAPRIS)

Study Overview
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Brief Summary
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Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF. The purpose of this study is to assess the treatment starting delay from the date of incarceration of inmates with chronic HCV infection (hepatitis C).

Detailed Description
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Detainees have specific health needs due to the high prevalence of several pathologies (HIV, HCV, tuberculosis, chronic diseases, addictions, psychiatric disorders associated in some cases with suicide attempts, etc.) and a degraded state of health. Detainees are frequently from the most disadvantaged social groups with low use of the health system prior to incarceration (drug users, people in precarious situations, migrants). Although there is no data available in France about the incidence of HCV on inmates, several studies in France have documented exposure to the risk of transmission of hepatitis C through drug injection practices and sharing of injection equipment. The ANRS-Coquelicot survey focused at the national level on drug users attending the center of reception and support to risk reduction for drug users and the center of Care, Support and Prevention of addiction. In this survey, 12% of drug users reported injecting drugs during one of their incarcerations (61% of these users reported having been incarcerated at least once in their lifetime) and 30% reported sharing their injection equipment on that occasion [5]. These data have been confirmed in local studies that show practices in the reuse and share of injection equipment [6]. The PREVACAR survey showed that 18% of prison staff reported finding syringes in detention in the past 12 months [7]. These data are confirmed by the PRIDE survey in which one-third of caregivers reported having treated abscesses in inmates, probably related to injection practices [8]. Because of this high prevalence and the risk of transmission between inmates, treatment of hepatitis C in prison is highly recommended ([9], [10]). However, there are difficulties in providing treatment. The main obstacle initially identified in 2014-15 was financial. Health care staff still face other challenges, particularly the difficulty of obtaining escorts in sufficient numbers to access technical trays and various consultations of local hospitals, with which the health units operate, and only 50% of medical extractions are carried out [12]. In addition, the conditions of medical extractions, with the almost systematic use of handcuffs and the frequent presence of supervisors at the consultation, while the assessment of the level of security to be implemented must be individualized (conditions noted by the evaluation report of the action plan and by the Controller of places of deprivation of liberty ( notice of 16/07/2015) often result in refusals on the part of detainees. Another obstacle to the treatment of inmates is the short length of incarceration in a detention facility with an unknown release date for persons on a warrant of deposit. The most common causes of discontinued treatment is release (8%) (1.4%)) [13]. The rapid start of treatment for 8 or 12 weeks will prevent the interruption of most treatments. In addition, extra-carceral consultations are offered to all inmates leaving the CPPLS. This possibility is recorded in the welcome booklet and will be recalled when the treatment is started. These consultations are made by UCSA's general practitioners every morning from Tuesday to Friday from 8:30 a.m. to 12:30 p.m., without an appointment, at the Achard Pavilion Polyclinic at Cochin Hospital. In accordance with the recommendations of the French Association for the Liver Study (AFEF) [14] this study proposes to optimize the medical care of prisoners with chronic HCV infection by reducing the time between diagnosis and on the way to AAD treatment, by using of the Xpert test® to determine the presence of viral RNA and also by extractions through a Fibroscan® to assess the degree of liver fibrosis. This study proposes to determine the DAA (Direct-Acting Antiviral) treatment time frame defined by the time between the day of incarceration and the day of the start of DAA treatment.

Official Title
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Hepatitis C in Prison: Study of Rapid Diagnosis and Treatment

Conditions
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Chronic HIV Infection

Intervention / Treatment
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* Other: Xpert® HCV Viral test
* Other: FibroScan® test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (>/= 18 years old), Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) coming from the state of freedom or transferred from another penitentiary establishment Serology HCV positive Exclusion Criteria: Major psychiatric disorders with loss of discernment Persons under guardianship or curatorship Persons not affiliated to a social security scheme

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All inmates entering the CPPLS<br>Patients with positive HCV serology | Other: Xpert® HCV Viral test<br>* an additional sample of 5 ml of blood will be taken for real-time HCV PCR by Xpert®, in addition to the blood samples taken as part of routine care.<br>Other: FibroScan® test<br>* A non invasive test made on a small area of skin coated with a gel<br>* Other names: Presence of liver fibrosis Presence and importance of fat overload in the liver;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay to treat inmates with chronic HCV infection. | The time frame for Direct-Acting Antiviral (DAA) treatment is defined by the time between the day of incarceration and the day of the DAA started. | up to 8 days from incarceration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the epidemiological data of the prison population of the Paris-La Santé Penitentiary Center (CPPLS) with positive HCV serology | Proportion of patients with positive HCV serology and description of clinical characteristics : age, transmission mode, co-infections (HIV, HBV) and comorbidities (alcohol, obesity, diabetes, renal failure), history of anti-HCV treatment. | At the inclusion | 
| Evaluate the rate of positive viral loads and describe the HCV genotypes in positive patients | Proportion of patients with a positive viral load by Xpert® HCV Viral test and proportion of the different HCV genotypes represented | At the inclusion | 
| Evaluate liver fibrosis of inmates with a positive HCV viral load | Proportion of patients with liver fibrosis assessed by FibroScan® test (level F1, F2, F3, F4) among patients with positive HCV viral load | At the inclusion | 
| Evaluate the cure rate at 12 weeks after the end of treatment | Proportion of patients with a negative HCV viral load at 12 weeks after stopping treatment Cures defined as an undetectable viral load 12 weeks after stopping treatment Duration of hepatitis C treatment | 12 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, DAA, HCV Viral test, liver fibrosis