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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV test | Diagnostic Test | Bedside rapid capillary HIV test |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV-IC | The number/categories of HIV-IC will be assessed. HIV-IC will be defined according to ECDC HIV-IC guidelines | Baseline |
| 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 |
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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:
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:
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Individuals admitted to various Units of San Raffaele Hospital (medical or surgical area).
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Nozza, MD | Università Vita-Salute San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Milan | 20127 | Italy |
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Overall 300 participants enrolled and completed the study. No screening failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV Diagnostic Test | Bedside rapid capillary HIV test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV Diagnostic Test | Bedside rapid capillary HIV test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline |
|
|
From enrollment to end of study procedures (same day)
Observational study with added procedure of HIV testing, no longitudinal follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV Diagnostic Test | Bedside rapid capillary HIV test | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Silvia Nozza | IRCCS San Raffaele Scientific Institute | +0039 0226437934 | nozza.silvia@hsr.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2023 | Feb 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000082922 | HIV Testing |
| ID | Term |
|---|---|
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Baseline |
| CD4+ Lymphocytes | CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis | Baseline |
| HIV-RNA | HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| HIV-IC | Participants may present with HIV indicator conditions belonging to group 1, 2, or 3. Accordingly, each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. The list of HIV-ICs is specified in the protocol in line with European guidelines. | Each participant may have no HIV-ICs, HIV-ICs from a single group, HIV-ICs from two groups, or HIV-ICs from all three groups. HIV-ICs comprise a predefined set of clinical conditions into three groups: group 1 includes AIDS-defining conditions; group 2 includes conditions associated with an undiagnosed HIV prevalence above the recommended testing threshold; and group 3 includes conditions for which failure to identify HIV infection may have important implications for clinical management. | Count of Participants | Participants |
|
|
| 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 | Not Posted | Baseline | Participants |
| 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 | Not Posted | Baseline | Participants |
| Secondary | CD4+ Lymphocytes | CD4+ lymphocytes (cells/microL) will be assessed among people with HIV infection at time of diagnosis | Posted | Median | Inter-Quartile Range | cells/microL | Baseline |
|
|
|
| Secondary | HIV-RNA | HIV-RNA levels (copies/mL) will be assessed among people with HIV infection at time of diagnosis | Posted | Median | Inter-Quartile Range | copies/mL | Baseline |
|
|
|
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008919 | Investigative Techniques |