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

NCT06282328 | Completed Results

• 1 other identifier: CET 26-2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; HIV Infections; AIDS

Keywords

HIV; Screening; HIV Testing; HIV Screening; HIV Indicator Conditions; HIV IC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of HIV-IC

  Baseline

• Number of Behavioral Risk Factors

  Baseline

• CD4+ Lymphocytes

  Baseline

• HIV-RNA

  Baseline

Interventions

HIV test DIAGNOSTIC_TEST

Bedside rapid capillary HIV test

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Castagna Antonella: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20127, Italy

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Silvia Nozza
• Organization: IRCCS San Raffaele Scientific Institute

nozza.silvia@hsr.it

+0039 0226437934

Study Officials

• Silvia Nozza, MD

  Vita-Salute San Raffaele University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: February 14, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)