HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting (HIV-HOTE)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Hiv; AIDS
• Intervention / Treatment: Diagnostic test: HIV test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20127
    • IRCCS San Raffaele Scientific Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 minors whose parents or legal guardians provide specific written informed consent for the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HIV-IC	The number/categories of HIV-IC will be assessed. HIV-IC will be defined according to ECDC HIV-IC guidelines	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	Baseline
CD4+ Lymphocytes	CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis	Baseline
HIV-RNA	HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis	Baseline

Collaborators and Investigators

• Sponsor: Castagna Antonella
• Investigators: Principal Investigator: Silvia Nozza, MD, Vita-Salute San Raffaele University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Screening; HIV Testing; HIV Screening; HIV Indicator Conditions; HIV IC
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Microbiological Techniques; HIV Testing
• Other Study ID Numbers: CET 26-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No