Evaluating undiagnosed HIV infections in hospitalized patients
HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study
This study is trying to find out how many hospitalized patients who show signs of HIV or have risky behaviors actually have undiagnosed HIV infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06282328 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of previously undiagnosed HIV infections among hospitalized individuals who exhibit at least one HIV indicator condition or engage in risky behaviors. Conducted at the San Raffaele Hospital in Milan, the study will collect clinical and laboratory data from patients admitted to various medical or surgical departments over a 24-month period. Participants will complete a questionnaire and provide blood samples to determine the presence of HIV. The study seeks to identify hidden cases of HIV to improve diagnosis and treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 years or older admitted to the hospital with at least one HIV indicator condition or behavioral risk factor for HIV.
Not a fit: Patients who have previously been diagnosed with HIV or who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of HIV in patients who are currently unaware of their infection status.
How similar studies have performed: Other studies have shown success in identifying undiagnosed HIV infections in hospital settings, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- IRCCS San Raffaele Scientific Institute — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Nozza, MD — Vita-Salute San Raffaele University
- Study coordinator: Silvia Nozza, MD
- Email: nozza.silvia@hsr.it
- Phone: +0039 0226437934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.