Targeted Nurse-driven HIV Screening in Emergency Departments

NCT02127424 | Completed

• 1 other identifier: K130601
• Study Type: interventional
• Target: 148,327
• Locations: 1 country
• Sites: 1

Brief Summary

To reduce late HIV diagnosis that remains common in France, the national health agency has promoted non-targeted HIV screening in health care settings, including emergency departments (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at high-risk. Our findings, consistent with results from other international groups, suggest that a targeted strategy could be feasible, efficient and cost-effective with fewer tests required. However, the feasibility and the efficacy of this strategy remain unknown in France. The main aim of the present study is to compare the efficacy of 2 strategies: 1) the combination of the nurse-driven HIV targeted screening and the current practice (physician-directed HIV diagnostic testing) versus 2) the current practice alone. The strategies will be compared during 2 randomly assigned periods (cluster randomization and cross-over) in 8 EDs of metropolitan Paris. During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years old, identified as high-risk by a self-administered questionnaire, not know to be HIV positive, not being seen for post-exposure prophylaxis or unstable medical illness, and accepting to participate by providing an informed consent. In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious disease specialist will be arranged within the following 48 hours.

Conditions

Targeted HIV Screening, Emergency Departments

Keywords

Nurse; Nursing; Screening; HIV; Emergency Service Hospital

Outcome Measures

Primary Outcomes (1)

• Number of patients with newly identified HIV infection among the number of 18-64 years patients visited EDs (apart from being seen at ED for prophylaxis after exposure to HIV) during the inclusion periods

  At the end of the expected total duration of the inclusion periods : up to 9 months in each center

Secondary Outcomes (7)

• Linkage into care of patients with newly diagnosed infection (Follow-up visit with an on-site infectious disease specialist)

  In the 3 months after the HIV screening at the emergency department

• Number of new HIV positive tests among the total number of tests

  At the end of the expected total duration of the inclusion periods : up to 9 months in each center

• Early detection of HIV (Proportion of patients with CD4>500/mm3, >350/mm3 and >200/mm3, and without HIV-related symptoms at presentation)

  In the 3 months after the HIV screening at the emergency department

• Feasibility of the nurse-driven HIV screening (Proportion of : filled-questionnaires, proposition of the nurse-driven HIV screening, acceptation by patients and HIV rapid tests done by nurses)

  At the end of the expected total duration of the inclusion periods : up to 9 months in each center

• Acceptability of the nurse-driven HIV screening by the caregivers (Interviews with nurses, nurse managers, physician doctors and hospital managers)

  Before and after the expected total duration of the inclusion periods : up to 9 months in each center

Study Arms (2)

Combination of the nurse-driven HIV targeted screening and the

EXPERIMENTAL

Nurses will offer screening to all patients at EDs, aged 18-64 years old, identified as high-risk by a self-administered questionnaire, not know to be HIV positive, accepting to participate by providing an informed consent and not being seen at ED for post-exposure prophylaxis or unstable medical illness. The questionnaire was previously tested in one ED. In case of reactive rapid test result, blood specimen will be collected for standard enzyme-linked immunosorbent assay and Western blot confirmation. A follow-up visit with an on-site infectious disease specialist will be arranged within the following 48 hours.

Procedure: Nurse-driven HIV targeted screening

Current practice (no intervention)

ACTIVE COMPARATOR

Physician-directed HIV diagnostic testing

Procedure: Current practice

Interventions

Nurse-driven HIV targeted screening PROCEDURE

Combination of the nurse-driven HIV targeted screening and the

Current practice PROCEDURE

Current practice (no intervention)

Eligibility Criteria

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

You may qualify if:

• Patients at EDs, aged 18-64 years old and not being seen at ED for post exposure prophylaxis

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (1)

Clinical Research Center (Centre de Recherche Clinique de l'Est Parisien, CRC-Est), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris (AP-HP)

Paris, 75012, France

Location

Related Publications (2)

• Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Cremieux AC; DICI-VIH (Depistage Infirmier CIble du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.

  PMID: 29092761 DERIVED

• Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Cremieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.

  PMID: 26831332 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: December 19, 2013
• First Posted: April 30, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 1, 2016

Record last verified: 2016-04

Locations

FR (1)