Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area?
试验速览
- 阶段
- 不适用
- 入组人数
- 487,000
- 主要终点
- Proportion of new HIV diagnoses among included patients.
研究概览
简要总结
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale.
The aim is to evaluate the impact of a wide implementation of nurse-driven HIV screening by rapid test in key populations combined with usual physician-directed diagnostic testing (intervention strategy) compared to diagnostic testing alone (control strategy) in the usual practice of the EDs.
The strategies will be compared during two periods in 18 EDs of Paris metropolitan area following a stepped-wedge cluster randomized trial.
During intervention period, nurses will suggest performing an HIV rapid test to patients belonging to key populations according to the answers to a self-administered questionnaire.
详细描述
Background:
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations of the National Health Authority (HAS) and expert group support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale in a context where local institutions are taking initiatives to curb the epidemic ("Pour une Ile-de-France sans sida", "Vers Paris sans sida").
Our hypothesis is that nurse-driven HIV screening for key populations can be integrated to the consultants' care pathway as usual practice of the ED and assured over the long term in the Paris metropolitan area; this strategy combined with physician-directed diagnostic testing could reduce undiagnosed infections and help control the epidemic.
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 64 years and visiting a participating ED for reasons other than a potential exposure to HIV within less than 48 hours
排除标准
- •Not applicable
结局指标
主要结局
Proportion of new HIV diagnoses among included patients.
时间窗: At the end of the expected total duration of the inclusion period: 11 months in each ED
次要结局
- Effectiveness of the screening processes used by the caregivers, particularly the integration of the electronic questionnaire, and used by the patients as well as acceptability(At the end of the expected total duration of the inclusion period: 11 months in each ED)
- Estimation through modelling of the number of new HIV diagnoses for different levels of coverage of the screening strategy in the Paris metropolitan area.(At the end of the expected total duration of the inclusion period: 11 months in each ED)
- Feasibility of the screening strategy and its implementation(At the end of the expected total duration of the inclusion period: 11 months in each ED)
- Proportions of patients with a new diagnosis(At the end of the expected total duration of the inclusion period: 11 months in each ED)