N/A
N=300
HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting
Hiv · HIV Infections · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT06282328 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Prevalence of HIV Infection — 6 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- HIV test (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Castagna Antonella
- Primary completion
- Oct 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of HIV Infection |
6 | — |
| SECONDARY Number of HIV-IC |
— | — |
| SECONDARY Number of Behavioral Risk Factors |
— | — |
| SECONDARY CD4+ Lymphocytes |
540 | — |
| SECONDARY HIV-RNA |
1,130,000 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT06282328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.