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 | Unknown

• 3 other identifiers: APHP1905022019-A02364-53ANRS 14055
• Study Type: interventional
• Target: 487,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiv; Nurse's Role

Keywords

Emergency service, Hospital; HIV; Mass screening; Nurses; Prevention and control; Key populations; Targeted screening

Outcome Measures

Primary Outcomes (1)

• Proportion of new HIV diagnoses among included patients.

  At the end of the expected total duration of the inclusion period: 11 months in each ED

Secondary Outcomes (4)

• 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

• 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

• Proportions of patients with a new diagnosis

  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

Study Arms (2)

Nurse-driven HIV screening for key populations+UD

EXPERIMENTAL

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

Procedure: Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing; Other: Physician-directed diagnostic testing

Physician-directed diagnostic testing alone

ACTIVE COMPARATOR

Other: Physician-directed diagnostic testing

Interventions

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

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.

Nurse-driven HIV screening for key populations+UD

Physician-directed diagnostic testing OTHER

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

Nurse-driven HIV screening for key populations+UD; Physician-directed diagnostic testing alone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- Not applicable

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Emergencies

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• judith LEBLANC

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith LEBLANC, RN, PhD

CONTACT

00 33 1 49 28 22 02; judith.leblanc@aphp.fr

Anne-Claude CREMIEUX, Md, PhD

CONTACT

00 33 1 49 28 22 02; anne-claude.cremieux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 6, 2020

Record last verified: 2020-03