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Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area? DEPIST Trial (ANRS 14055)

NCT04298801 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 487000

Last updated 2020-03-06

No results posted yet for this study

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.

Conditions

  • Hiv
  • Nurse's Role

Interventions

PROCEDURE

Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing

A self-administered questionnaire on HIV exposure factors will be offered to all patients of ages 18-64 able to complete it. This questionnaire will be available in a paper-based format, electronic format on the patient phone or can be conducted verbally by the nurse. According to the answers, the nurses will suggest performing a rapid test to patients belonging to key populations. A finger-stick rapid HIV test will be performed and results will be disclosed by the nurse assisted by a physician if necessary. If needed, a follow-up visit with an infectious disease specialist will be scheduled within 72 hours.

OTHER

Physician-directed diagnostic testing

Throughout the intervention, physicians will prescribe HIV tests to patients with HIV-related symptoms, following usual practice.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • judith LEBLANC · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298801 on ClinicalTrials.gov