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

NCT06282328 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-03-30

Study results available
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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

Interventions

DIAGNOSTIC_TEST

HIV test

Bedside rapid capillary HIV test

Sponsors & Collaborators

  • Castagna Antonella

    lead OTHER

Principal Investigators

  • Silvia Nozza, MD · Vita-Salute San Raffaele University

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06282328 on ClinicalTrials.gov