Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area?
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 487,000
- Primary Endpoint
- Proportion of new HIV diagnoses among included patients.
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Not applicable
Arms & Interventions
Nurse-driven HIV screening for key populations+UD
Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing (UD)
Intervention: Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing (Procedure)
Nurse-driven HIV screening for key populations+UD
Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing (UD)
Intervention: Physician-directed diagnostic testing (Other)
Physician-directed diagnostic testing alone
Intervention: Physician-directed diagnostic testing (Other)
Outcomes
Primary Outcomes
Proportion of new HIV diagnoses among included patients.
Time Frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
Secondary Outcomes
- 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)