HivHIV-HOTENCT06282328

HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting

An observational study of Hiv and HIV Infections, run by Castagna Antonella at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors. Read more about this study

Who is it for?: Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for: Hiv, HIV Infections, AIDS
What is being tested?: HIV test
How many people: 300 participants
Where: 1 siteItaly
Study dates: 14 Feb 2024to 15 Oct 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Individuals admitted to various Units of San Raffaele Hospital (medical or surgical area).

Who may be able to join

Individuals admitted to various Units of IRCCS San Raffaele Hospital.
Individuals aged 14 years or older.
Individuals meeting at least one of the following criteria:
Presence of at least one HIV-IC.
Presence of at least one behavioral risk factors for HIV infection.
Individuals providing specific written informed consent for the study, or minors whose parents or legal guardians provide specific written informed consent for the study.

Who cannot join

Individuals not providing specific written informed consent for the study.
Individuals with previously known HIV infection.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS San Raffaele Scientific Institute
Milan, 20127

Other trials in Italy

About this study

Official title: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study

This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.

The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.

Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.

In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day.

Read the detailed description

Study Objective:

Study Design:

Study Duration:

The overall study duration is 24 months, with recruitment lasting 20 months, data extraction and review taking 2 months, statistical analysis requiring 1 month, and result writing taking 1 month.

Study Procedure:

Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.

Additional Procedures or Analyses:

Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.
In case of a positive rapid capillary HIV test result, antigen/antibody testing (using Cobas 6800®) and Western Blot for HIV confirmation will be performed on venous blood samples on the same day at the San Raffaele Hospital virology laboratory in Milan.
If HIV infection is confirmed, an infectious disease specialist will assess the patient within 48 hours of diagnosis and request viral load determination (HIV-RNA), CD4+ lymphocyte count. The individual will also be directed to follow-up care at the Infectious Diseases Unit of San Raffaele Hospital, with subsequent linkage to care and start of antiretroviral therapy (ART), according to clinical practice.
If the capillary HIV test result is negative, the patient will be informed of the negative result.

Conditions: Hiv, HIV Infections, AIDS
Being tested: HIV test
Keywords: HIV, Screening, HIV Testing, HIV Screening, HIV Indicator Conditions, HIV IC
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIV testDiagnostic test
Bedside rapid capillary HIV test

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of HIV Infection
The primary objective of the study is to estimate the prevalence of previously unknown HIV infection (new HIV infection) in the hospital setting among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or with presence of behavioral risk factors
Measured: Baseline

Secondary outcomes (4)

Number of HIV-IC
The number/categories of HIV-IC will be assessed. HIV-IC will be defined according to ECDC HIV-IC guidelines
Measured: Baseline
Number of Behavioral Risk Factors
The number/type of behavioral risk factors will be assessed. Presence of behavioral risk factors for HIV infection will be evaluated by means of a questionnaire designed for the trial
Measured: Baseline
CD4+ Lymphocytes
CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis
Measured: Baseline
HIV-RNA
HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202415 Oct 2025

First posted28 Feb 2024
Study start14 Feb 2024
Primary completion15 Oct 2025
Study completion15 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HivStudies 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: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06282328
Sponsor's protocol ID: CET 26-2024
Acronym: HIV-HOTE
Status last verified: Mar 2026
First submitted: 14 Feb 2024
Last updated: 30 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
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Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
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Recruiting
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Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Hiv trials

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: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study
ClinicalTrials.gov ID: NCT06282328
Acronym / sponsor ID: HIV-HOTE / CET 26-2024
Conditions: Hiv, HIV Infections, AIDS
Keywords: HIV, Screening, HIV Testing, HIV Screening, HIV Indicator Conditions, HIV IC
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Castagna AntonellaUniversity, hospital or other
Study start: 14 Feb 2024 (actual)
Primary completion: 15 Oct 2025 (actual)
Study completion: 15 Oct 2025 (actual)
First posted: 28 Feb 2024 (actual)
Results: Posted 30 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day.

Detailed description

Study Objective:

Study Design:

Study Duration:

The overall study duration is 24 months, with recruitment lasting 20 months, data extraction and review taking 2 months, statistical analysis requiring 1 month, and result writing taking 1 month.

Study Procedure:

Additional Procedures or Analyses:

Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.
In case of a positive rapid capillary HIV test result, antigen/antibody testing (using Cobas 6800®) and Western Blot for HIV confirmation will be performed on venous blood samples on the same day at the San Raffaele Hospital virology laboratory in Milan.
If HIV infection is confirmed, an infectious disease specialist will assess the patient within 48 hours of diagnosis and request viral load determination (HIV-RNA), CD4+ lymphocyte count. The individual will also be directed to follow-up care at the Infectious Diseases Unit of San Raffaele Hospital, with subsequent linkage to care and start of antiretroviral therapy (ART), according to clinical practice.
If the capillary HIV test result is negative, the patient will be informed of the negative result.

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Individuals admitted to various Units of San Raffaele Hospital (medical or surgical area).

Key inclusion criteria (6 listed)

Individuals admitted to various Units of IRCCS San Raffaele Hospital.
Individuals aged 14 years or older.
Individuals meeting at least one of the following criteria:
Individuals providing specific written informed consent for the study, or minors whose parents or legal guardians provide specific written informed consent for the study.

Key exclusion criteria (2 listed)

Individuals not providing specific written informed consent for the study.
Individuals with previously known HIV infection.

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
HIV testBedside rapid capillary HIV test	Diagnostic test	–

Primary outcome

Prevalence of HIV Infection
Time frame: Baseline
The primary objective of the study is to estimate the prevalence of previously unknown HIV infection (new HIV infection) in the hospital setting among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or with presence of behavioral risk factors

4 secondary outcomes

Number of HIV-IC
Time frame: Baseline
Number of Behavioral Risk Factors
Time frame: Baseline
CD4+ Lymphocytes
Time frame: Baseline
HIV-RNA
Time frame: Baseline

Results and safety

Results posted to the registry on 30 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV Diagnostic Test	300	300

Primary outcome: Prevalence of HIV Infection

Time frame: Baseline. Count of participants. Unit: Participants

Measure	HIV Diagnostic Test n = 300
Value	6

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of study procedures (same day). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Diagnostic Test	0 of 300 (0%)	0 of 300 (0%)	0 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hiv

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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. This study is not recruiting at the moment.

Silvia Nozza, MD principal investigator

Università Vita-Salute San Raffaele

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hiv and HIV Infections, run by Castagna Antonella 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 6 inclusion and 2 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: finished, 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?

Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HIV Infection (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282328.

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.