Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Диагностический тест Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination
  * Intake and Information * Obtaining informed consent: Each participant will sign the informed consent form and data processing consent form, ensuring the voluntary nature of the screening * Conducting the screening: All migrants will undergo, on a single occasion: * Medical history: travel history, focused primarily on identifying the migration route; recent and past medical history, including both physiological and pathological aspects, with the aim of identifying risk factors, signs, and sy

Первичные конечные точки

• Prevalence of infections and infectious diseases [Срок оценки: At baseline]

Вторичные конечные точки (1)

• Proportion of infections of interest, stratified by macro-geographical area of origin [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Италия · 1 центр

• IRCCS Sacro Cuore Don Calabria — Negrar

Идентификаторы

NCT: NCT07487506 · 2024-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗