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

NCT05649202 | Withdrawn

• 2 other identifiers: APHP1909482019-A01418-49
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic HIV Infection

Keywords

Hepatitis C; DAA; HCV Viral test; liver fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Describe the epidemiological data of the prison population of the Paris-La Santé Penitentiary Center (CPPLS) with positive HCV serology

  At the inclusion

• Evaluate the rate of positive viral loads and describe the HCV genotypes in positive patients

  At the inclusion

• Evaluate liver fibrosis of inmates with a positive HCV viral load

  At the inclusion

• Evaluate the cure rate at 12 weeks after the end of treatment

  12 weeks after the end of treatment

Study Arms (1)

All inmates entering the CPPLS

Patients with positive HCV serology

Other: Xpert® HCV Viral test; Other: FibroScan® test

Interventions

Xpert® HCV Viral test OTHER

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.

All inmates entering the CPPLS

FibroScan® test OTHER

A non invasive test made on a small area of skin coated with a gel

Also known as: Presence of liver fibrosis Presence and importance of fat overload in the liver

All inmates entering the CPPLS

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Major psychiatric disorders with loss of discernment
• Persons under guardianship or curatorship
• Persons not affiliated to a social security scheme

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, 75014, France

Location

Related Publications (12)

• Chiron E, Jauffret-Roustide M, Le Strat Y, Chemlal K, Valentin MA, Serre P, et al. Prévalence de l'infection par le VIH et le virus de l'hépatite C chez les personnes détenues en France. Résultats de l'enquête Prévacar 2010. Bull Epidemiol Hebd 2013 ; 35-36 : 445-50.

  BACKGROUND

• Semaille C, Le Strat Y, Chiron E, Chemlal K, Valantin MA, Serre P, Cate L, Barbier C, Jauffret-Roustide M; Prevacar Group. Prevalence of human immunodeficiency virus and hepatitis C virus among French prison inmates in 2010: a challenge for public health policy. Euro Surveill. 2013 Jul 11;18(28):20524. doi: 10.2807/1560-7917.es2013.18.28.20524.

  PMID: 23870097 BACKGROUND

• Jauffret-Roustide M, Le Strat Y, Couturier E, Thierry D, Rondy M, Quaglia M, Razafandratsima N, Emmanuelli J, Guibert G, Barin F, Desenclos JC. A national cross-sectional study among drug-users in France: epidemiology of HCV and highlight on practical and statistical aspects of the design. BMC Infect Dis. 2009 Jul 16;9:113. doi: 10.1186/1471-2334-9-113.

  PMID: 19607712 BACKGROUND

• Sannier O, Verfaillie F, Lavielle D. [Risk reduction and drug use in detention: study about the detainees of Liancourt Penitentiary]. Presse Med. 2012 Jul;41(7-8):e375-85. doi: 10.1016/j.lpm.2011.12.015. Epub 2012 Mar 2. French.

  PMID: 22386285 BACKGROUND

• Chemlal K, Bouscaillou J, Jauffret-Roustide M, Semaille C, Barbier C, Michon C, et al. Offre de soins en milieu carcéral en France : infection par le VIH et les hépatites. Enquête Prévacar, 2010. Bull Epidemiol Hebd 2012 ; 10-11 : 131-34.

  BACKGROUND

• Michel L, Lions C, Van Malderen S, Schiltz J, Vanderplasschen W, Holm K, Kolind T, Nava F, Weltzien N, Moser A, Jauffret-Roustide M, Maguet O, Carrieri PM, Brentari C, Stover H. Insufficient access to harm reduction measures in prisons in 5 countries (PRIDE Europe): a shared European public health concern. BMC Public Health. 2015 Oct 27;15:1093. doi: 10.1186/s12889-015-2421-y.

  PMID: 26507505 BACKGROUND

• Circulaire DGOS/R1/R4/DSS/1A/1C/2A n° 2015-148 du 29 avril 2015 relative à la facturation des AAD pour les patients pris en charge en ambulatoire dans des unités sanitaires en milieu pénitentiaire. http://social-sante.gouv.fr/fichiers/bo/2015/15-06/ste_20150006_0000_0065.pdf

  BACKGROUND

• Brahmy B. [Difficulties medical care of persons placed under hand of justice]. Rev Prat. 2013 Jan;63(1):93-6. French.

  PMID: 23457838 BACKGROUND

• Juan Jd, de la Hoya PS, Marco A, Anton JJ, Faraco I, Yllobre C, Pozo E, Hoyos C. Multicenter study on the discontinuation and efficacy of chronic hepatitis C treatment in the Spanish penitentiary population (EPIBAND study). Eur J Gastroenterol Hepatol. 2014 Oct;26(10):1083-9. doi: 10.1097/MEG.0000000000000163.

  PMID: 25076064 BACKGROUND

• Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.

  PMID: 29534185 BACKGROUND

• McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.

  PMID: 28275079 BACKGROUND

• Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I, Garg J, Wei LJ, McHutchison JG. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1-3. doi: 10.1016/j.cgh.2014.12.014. Epub 2014 Dec 18.

  PMID: 25528010 BACKGROUND

Related Links

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MeSH Terms

Conditions

Hepatitis C; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin ANDREW SILBERMANN, MsD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: December 13, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)