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临床试验/NCT06528626
NCT06528626招募中不适用

Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to Identify People At Risk or Already Infected with HIV and HCV

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 240,000 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240,000
试验地点
2
主要终点
Implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests

研究概览

简要总结

Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV

详细描述

Objectives: To reduce hidden and incident HIV and HCV infection, through the implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests (RT), in the Health Centers (HC). Methodology: stepped-wedge cluster randomized trial in 8 CS of the community of Madrid, to to know if the implementation of the 2 tools described above, improve risk identification and subsequent screening for HIV and HCV infection. In the standard of care branch (SOC), the health personnel will ask people a series of questions to identify the HIV risk exposition, and also they will be provided pop-up computer alerts of HIV indicator conditions in the electronic medical record, moreover HIV and HCV serological tests will be carried out in the reference laboratory, while in the intervention branch in addition to the SOC, a SQ-R&IC of HIV and HCV will be made available to the HC population, through a quick response (QR) code, as well as HIV and HCV RT. The variables that will be compared are the percentage of HIV and HCV tests performed, of people referred to receive PrEP, and of new HIV and HCV diagnoses or not linked to care that are made during the periods assigned to the EDC branch vs. those in the intervention branch.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate.

排除标准

  • Having already been included in the study, not signing the consent.

结局指标

主要结局

Implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests

时间窗: 3 years

Number of Participants With the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests, Change From Baseline in hidden and incident HIV and HCV infection at 3 Years

次要结局

未报告次要终点

研究者

研究点 (2)

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