HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting

HIV Infections Clinical Trial

— HIV-HOTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282328
• Other study ID #: CET 26-2024
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Silvia Nozza, MD
• Phone: +0039 0226437934
• Email: nozza.silvia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• Hiv
• HIV Infections

Intervention

Diagnostic Test:
• HIV test
Bedside rapid capillary HIV test

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Castagna Antonella

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HIV infection	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	Month 20
Secondary	Number of HIV-IC	The number/categories of HIV-IC will be assessed. HIV-IC will be defined according to ECDC HIV-IC guidelines	Month 20
Secondary	Number of Behavioral Risk Factors	The number/type of behavioral risk factors will be assessed. Presence of behavioral risk factors for HIV infection will be evaluated by means of a questionnaire designed for the trial	Month 20
Secondary	CD4+ lymphocytes	CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis	Month 20
Secondary	HIV-RNA	HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis	Month 20