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临床试验/NCT05649202
NCT05649202撤回不适用

Hepatitis C in Prison: Study of Rapid Diagnosis and Treatment

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
24
试验地点
2
主要终点
Delay to treat inmates with chronic HCV infection.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

All inmates entering the CPPLS

Patients with positive HCV serology

干预措施: Xpert® HCV Viral test (Other)

All inmates entering the CPPLS

Patients with positive HCV serology

干预措施: FibroScan® test (Other)

结局指标

主要结局

Delay to treat inmates with chronic HCV infection.

时间窗: 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.

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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