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RecruitingNCT07487506REACHUpdated Mar 30, 2026

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

An interventional study of Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination in Infections, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2025, registered Mar 2026).
  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Infections

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03

In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's planned enrollment of 250 is above the median of 113 across 1,304 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Screening Cohort

    Screening for: * Tuberculosis * Syphilis * HIV * HBV * HCV * Intestinal helminthiasis * Strongyloidiasis * Schistosomiasis * Filariasis

    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

Interventions

  • Diagnostic testMedical 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 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07487506
Lead sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Responsible party
Sponsor
First posted
Mar 23, 2026
Start date
Apr 8, 2025
Primary completion
Sep 8, 2026 (estimated)
Completion
Sep 8, 2026 (estimated)
Last update
Mar 30, 2026

Study contacts

Elvia Malo, Dr.
Contact
elvia.malo@sacrocuore.it
0456013111

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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