HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting
NCT ID: NCT06282328
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2024-02-14
2025-10-15
Brief Summary
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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.
Detailed Description
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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.
Study Design:
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.
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
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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HIV test
Bedside rapid capillary HIV test
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Individuals with previously known HIV infection.
14 Years
ALL
Yes
Sponsors
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Castagna Antonella
OTHER
Responsible Party
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Castagna Antonella
Prof
Principal Investigators
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Silvia Nozza, MD
Role: PRINCIPAL_INVESTIGATOR
Vita-Salute San Raffaele University
Locations
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IRCCS San Raffaele Scientific Institute
Milan, , Italy
Countries
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Other Identifiers
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CET 26-2024
Identifier Type: -
Identifier Source: org_study_id