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

ConditionInfections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination

    Diagnostic test

    * 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 symptoms of major communicable and non-communicable diseases; * Measurement of vital signs (blood pressure, oxygen saturation, heart rate) and weight; * Physical examination; * Blood draw for the following tests: complete blood count with differential, ALT, creatinine + eGFR, urea, blood glucose; * Urine collection for a complete urinalysis and a urological parasitological examination; * Stool collection for a coprological parasitological examination

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Screening CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of infections and infectious diseases

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

Time frame
At baseline

Secondary outcomes

1

Proportion of infections of interest, stratified by macro-geographical area of origin

Estimate of the proportion of infections of interest, stratified by macro-geographical area of origin of asylum seekers

Time frame
At baseline

Other outcomes

Sponsors and contacts

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