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

April 30, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Hepatitis C in Prison: Study of Rapid Diagnosis and Treatment

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Internal Medicine Service, Cochin Hospital (Consultation and Ambulatory Care Unit (UCSA) within the Paris-La Santé Penitentiary Center (CPPLS))

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) from the state of liberty or transferred from another prison who have a positive HCV serology

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All inmates entering the CPPLS
Patients with positive HCV serology
Other: Xpert® HCV Viral test
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.
Other: FibroScan® test
A non invasive test made on a small area of skin coated with a gel
Other Names:
  • Presence of liver fibrosis Presence and importance of fat overload in the liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay to treat inmates with chronic HCV infection.
Time Frame: up to 8 days from incarceration
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
Time Frame: At the inclusion
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
Time Frame: At the inclusion
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
Time Frame: At the inclusion
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Benjamin ANDREW SILBERMANN, MsD, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

December 10, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190948
  • 2019-A01418-49 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic HIV Infection

Clinical Trials on Xpert® HCV Viral test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe