HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
IRCCS San Raffaele Scientific Institute
RECRUITING
Milan
Contact Information
Primary
Silvia Nozza, MD
nozza.silvia@hsr.it
+0039 0226437934
Backup
Elisabetta Carini
carini.elisabetta@hsr.it
+0039 0226437934
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Leads: Castagna Antonella

This content was sourced from clinicaltrials.gov