Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination.
- Who it may be relevant to
- Registry conditions: Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
REACH - Responsive Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers
Overview
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.
Detailed description
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
Interventions
- Diagnostic test 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
Primary outcome measures
- Prevalence of infections and infectious diseases [Time frame: At baseline]
Secondary outcome measures (1)
- Proportion of infections of interest, stratified by macro-geographical area of origin [Time frame: At baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Italy · 1 center
- IRCCS Sacro Cuore Don Calabria — Negrar
Identifiers
NCT: NCT07487506 · 2024-48