InfectionsREACHNCT07487506
Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers
A study testing 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 people with Infections, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, Verona, 37024
Tamara Ursini, 0456014874, tamara.ursini@sacrocuore.it
About this study
Official title: REACH - Responsive 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.
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
- Conditions
- Infections
- Being tested
- Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examination
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical history, measurement of vital signs and weight, Blood sample for blood testing, Collection of urine and collection of stool for a coproparasitological examinationDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Screening Cohort | Experimental | Screening for:
* Tuberculosis
* Syphilis
* HIV
* HBV
* HCV
* Intestinal helminthiasis
* Strongyloidiasis
* Schistosomiasis
* Filariasis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start8 Apr 2025
- Primary completion8 Sep 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487506
- Sponsor's protocol ID
- 2024-48
- Acronym
- REACH
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH - Responsive Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers
- ClinicalTrials.gov ID
- NCT07487506
- Acronym / sponsor ID
- REACH / 2024-48
- Conditions
- Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening Cohort | Experimental | 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 examinationScreening for: * Tuberculosis * Syphilis * HIV * HBV * HCV * Intestinal helminthiasis * Strongyloidiasis * Schistosomiasis * Filariasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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 | Diagnostic test | Screening Cohort |
Primary outcome
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
1 secondary outcome
Proportion of infections of interest, stratified by macro-geographical area of origin
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Infections, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo, Dr. (0456013111, elvia.malo@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of infections and infectious diseases (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.