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临床试验/NCT07487506
NCT07487506招募中不适用

REACH - Responsive Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers

IRCCS Sacro Cuore Don Calabria di Negrar1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年4月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Prevalence of infections and infectious diseases

研究概览

简要总结

A single-centre, non-profit experimental clinical trial. The aim of the study is to estimate the prevalence of a range of infections and infectious diseases in a cohort of asylum seekers staying in initial reception centres, who have been in Italy for at least 2 months but no more than 36 months. The infections of interest are: latent tuberculosis and active tuberculosis, HIV, HBV, HCV, syphilis, strongyloidiasis, schistosomiasis, filariasis, and intestinal helminthiasis.

详细描述

A single-centre, non-profit experimental clinical trial. The aim of the study is to estimate the prevalence of a range of infections and infectious diseases in a cohort of asylum seekers staying in initial reception centres, who have been in Italy for at least 2 months but no more than 36 months. The infections of interest are: latent tuberculosis and active tuberculosis, HIV, HBV, HCV, syphilis, strongyloidiasis, schistosomiasis, filariasis, and intestinal helminthiasis.

All migrants will undergo, on a single occasion:

  • Medical history: travel history, focusing primarily on identifying the migration route; recent and past medical history, with the aim of identifying risk factors, signs and symptoms of the main communicable and non-communicable diseases;
  • Measurement of vital signs (blood pressure, oxygen saturation, heart rate) and weight;
  • Physical examination;
  • Blood sampling for the following tests: complete blood count with differential, ALT, creatinine + eGFR, urea, blood glucose; serology for HCV, HIV, Treponema, HBV marker, Quantiferon test, Strongyloides serology, Schistosoma serology (if indicated), filarial serology (if indicated);
  • Urine collection for a complete urinalysis and a urological parasitological examination (if indicated);
  • Stool collection for a faecal parasitological examination

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

入选标准

  • All asylum seekers residing in reception centers who are 18 years of age or older, have been in Italy for at least 2 months but no more than 36 months, who express their consent to undergo screening.

排除标准

  • Individuals under the age of 18; Asylum seekers who have been in Italy for less than 2 months or for more than 36 months; Refusal to consent to participate in the study

结局指标

主要结局

Prevalence of infections and infectious diseases

时间窗: At baseline

Estimation of the prevalence of a range of infections and infectious diseases in a cohort of asylum seekers staying in initial reception centres, who arrived in Italy between 2 and 36 months ago. The infections of interest are: latent tuberculosis and active tuberculosis, HIV, HBV, HCV, syphilis, strongyloidiasis, schistosomiasis, filariasis and intestinal helminthia

次要结局

  • Proportion of infections of interest, stratified by macro-geographical area of origin(At baseline)

研究者

发起方
IRCCS Sacro Cuore Don Calabria di Negrar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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