HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting: A Monocentric Observational Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevalence of HIV infection
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Individuals not providing specific written informed consent for the study.
- •Individuals with previously known HIV infection.
结局指标
主要结局
Prevalence of HIV infection
时间窗: Month 20
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
次要结局
- Number of Behavioral Risk Factors(Month 20)
- CD4+ lymphocytes(Month 20)
- Number of HIV-IC(Month 20)
- HIV-RNA(Month 20)
研究者
Castagna Antonella
Prof
IRCCS San Raffaele