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临床试验/NCT04366492
NCT04366492已完成不适用

Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System

Hasselt University2 个研究点 分布在 1 个国家目标入组 3,045 人开始时间: 2019年4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
已完成
发起方
入组人数
3,045
试验地点
2
主要终点
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)

研究概览

简要总结

To assess the prevalence of blood-borne viral infections in prisons in Belgium, screening will be executed in several prisons in Flanders, Brussels and Wallonia to obtain a geographical representative distribution.

Upon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for HCV Ab, HBsAg and HIV. Screening will be performed first. While awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for HCV, HBV and HIV infection. This questionnaire is filled out directly online, and will be immediately implemented in the encoded database. The database is set-up according to the rules of good clinical practice. (Castor EDC software). The results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •Age ≥ 18 years
  • •Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial
  • •Written informed consent obtained

排除标准

  • •Written informed consent not possible: (language barrier, illiteracy)
  • •Already participated in the study: re-entry within inclusion period in one of the prisons

研究组 & 干预措施

persons in prison

Other

干预措施: Prevalence of blood borne viral infections (HBV/HCV/HIV) (Other)

结局指标

主要结局

Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)

时间窗: day 1

test using whole capillary blood (finger prick testing)

Number of participants with HBsAg+ (Hepatitis B surface Antigen)

时间窗: day 1

test using whole capillary blood (finger prick testing)

Number of participants with HIV Ab+ (human immunodeficiency virus antibody)

时间窗: day1

test using whole capillary blood (finger prick testing)

次要结局

  • .Prevalence of blood-borne viral infections in Belgian prisons(day 1)
  • 5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison(day 1)
  • Analysis of uptake counselling by physician in prison(day 1)
  • Analysis of uptake of anti(retro)viral treatment(day 1)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geert Robaeys

Principal Investigator

Hasselt University

研究点 (2)

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