Clinical trial NCT06282328: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting
Official title: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hiv
HIV Infections
AIDS
Keywords: HIV
Screening
HIV Testing
HIV Screening
HIV Indicator Conditions
HIV IC
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals admitted to various Units of San Raffaele Hospital (medical or surgical area).

Brief 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.

Detailed description: Study Objective:

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.

Study Design:

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.

Study Duration:

The overall study duration is 24 months, with recruitment lasting 20 months, data extraction and review taking 2 months, statistical analysis requiring 1 month, and result writing taking 1 month.

Study Procedure:

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.

Additional Procedures or Analyses:

* 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 (using Cobas 6800®) and Western Blot for HIV confirmation will be performed on venous blood samples on the same day at the San Raffaele Hospital virology laboratory in Milan.
* If HIV infection is confirmed, an infectious disease specialist will assess the patient within 48 hours of diagnosis and request viral load determination (HIV-RNA), CD4+ lymphocyte count. The individual will also be directed to follow-up care at the Infectious Diseases Unit of San Raffaele Hospital, with subsequent linkage to care and start of antiretroviral therapy (ART), according to clinical practice.
* If the capillary HIV test result is negative, the patient will be informed of the negative result.

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.

Primary outcomes:
measure: Prevalence of HIV infection
timeFrame: Month 20
Secondary outcomes:
measure: Number of HIV-IC
timeFrame: Month 20
measure: Number of Behavioral Risk Factors
timeFrame: Month 20
measure: CD4+ lymphocytes
timeFrame: Month 20
measure: HIV-RNA
timeFrame: Month 20
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: Vita-Salute San Raffaele University
name: Silvia Nozza, MD
role: PRINCIPAL_INVESTIGATOR
References: