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

Last updated: May 5, 2025
Sponsor: Castagna Antonella
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Hiv Infections

Treatment

HIV test

Clinical Study ID

NCT06282328
CET 26-2024
  • Ages > 14
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 minorswhose parents or legal guardians provide specific written informed consent for thestudy.

Exclusion

Exclusion Criteria:

  • Individuals not providing specific written informed consent for the study.

  • Individuals with previously known HIV infection.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: HIV test
Phase:
Study Start date:
February 14, 2024
Estimated Completion Date:
March 01, 2026

Study Description

Study Objective:

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.

Connect with a study center

  • IRCCS San Raffaele Scientific Institute

    Milan, 20127
    Italy

    Active - Recruiting

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