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

NCT07487506 | Recruiting

• 1 other identifier: 2024-48
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections

Outcome Measures

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

  At baseline

Secondary Outcomes (1)

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

  At baseline

Study Arms (1)

Screening Cohort

EXPERIMENTAL

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

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

Screening Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection; Hematologic Tests

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Elvia Malo, Dr.

CONTACT

0456013111; elvia.malo@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 8, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)