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临床试验/NCT04959643
NCT04959643Unknown不适用

Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年10月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Rate of performed TROD

研究概览

简要总结

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.

详细描述

Context :

Even if the rate of under-screening for viral hepatitis B and C is getting better, the situation is still concerning. In France, it has been estimated that about 100 000 people have a positive serology for hepatitis C, and that 75,000 are unaware of it. People in vulnerable situations such as migrants or people in very precarious situations have an increased risk of having been infected by one of these two viral hepatitises.

The Précavir study established the effecacy of systematic screening for viral hepatitis during a consultation at a continuous health care access center (Permanence d'accès aux soins, PASS). Screening in the same location as the consultation is recommended, as well as the creation of a clear care pathway (Roudot-Thoraval et al. BEH 14-15 2017).

According to another study conducted in the Ile de France region, in consultations dedicated to migrants, the prevalences of hepatitis B and C were 6.8% and 1.8% respectively; whereas the vast majority of infected persons were unaware of their positivity (Revault et al. BEH 14-15; 2017). These vulnerable populations are a priority for individuals and for public health in terms of viral hepatitis screening, care and prevention.

Systematic screening for hepatitis C is justified by the now universal access to treatment and by the remarkable efficacy (>95%) of new treatments against the hepatitis C virus. These pan-genotypic treatments are prescribed for a short amount of time and have very few adverse effects. Systematic screening as well as the implementation of treatment against hepatitis C are essential in a view to obtain the elimination of hepatitis C in 2030 for the WHO and in 2025 for France. To this date, without screening and systematic initiation of treatment, the various models are unanimous that this objective cannot be achieved. We must therefore take advantage of all medical opportunities to offer this simple and cost-effective screening.

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
All
接受健康志愿者

入选标准

  • People of 18 years old and more
  • Non objection to be a participant of the study

排除标准

  • Exclusion period determined by a previous study
  • Judicial protection (sauvegarde de justice, tutelle or curatelle)
  • Impossibility of offering clear information to the subject

结局指标

主要结局

Rate of performed TROD

时间窗: Inclusion visit

Proportion of performed TROD out on the number of people it has been offered.

次要结局

  • Signs of portal hyperpressure of people with hepatitis.(Inclusion visit)
  • Prevalence of hepatits B in the population(Inclusion visit)
  • Sex(Inclusion visit)
  • Housing status(Inclusion visit)
  • Signs of hepatocellular insuffisance of people with hepatitis.(Inclusion visit)
  • Care Cascade for HBV(3 months)
  • Life location in the last 6 months(Inclusion visit)
  • Age(Inclusion visit)
  • Care Cascade for HCV(6 months)
  • Social care access(Inclusion visit)
  • Smoking status of people(Inclusion visit)
  • Alcohol high use(Inclusion visit)
  • Usage of a care facility in Montpellier in the last year(Inclusion visit)
  • Knowing of the serological status(Inclusion visit)
  • Prevalence of hepatits C in the population(Inclusion visit)
  • Weight of people with hepatitis(Inclusion visit)
  • Height of people with hepatitis(Inclusion visit)
  • Cardiac frequency of people with hepatitis.(Inclusion visit)
  • Blood pressure of people with hepatitis(Inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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