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NCT Number: NCT07487506

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

Location status: Recruiting

Location contact

Tamara Ursini

CONTACT

[email protected]

0456014874

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Prevalence of infections and infectious diseases

    Time frame: 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

Secondary outcomes

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

    Time frame: At baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elvia Malo, Dr.

CONTACT

[email protected]

0456013111

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

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

Acronym: REACH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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