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HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting
trial testing HIV test in Hiv in 300 participants. Completed in 15 October 2025.
| Lead sponsor | Castagna Antonella |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 14 February 2024 |
| Primary completion | 15 October 2025 |
| Estimated completion | 15 October 2025 |
| Sites | 1 location across Italy |
Castagna Antonella — full company profile →
14 and older, any sex, with Hiv or HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| HIV Diagnostic Test | 6 |
CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis
| Group | Value | 95% CI |
|---|---|---|
| Reactive HIV Test | 540 | 199 – 760 |
HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis
| Group | Value | 95% CI |
|---|---|---|
| Reactive HIV Test | 1,130,000 | 138,500 – 2,337,500 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing