The Impact of Nurse-Driven Targeted HIV Screening in 8 Emergency Departments: Study Protocol for the DICI-VIH Cluster-Randomized Two-Period Crossover Trial

Background

In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone.

Methods/Design

DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France’s new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in the control and targeted groups respectively, a sample size of 140,000 patients was estimated corresponding to 8,750 patients per ED and per period. Inclusions started in June 2014. Results are expected by mid-2016.

Discussion

The DICI-VIH study is the first large randomized controlled trial designed to assess nurse-driven targeted HIV screening. This study can provide valuable information on HIV screening in health care settings.

Below:  DICI-VIH questionnaire

Below:  DICI-VIH flow diagram following CONSORT

Below:  DICI-VIH flow chart

Full article at:   http://goo.gl/gTxZgV

By:  Judith Leblanc, Alexandra Rousseau, Gilles Hejblum, Isabelle Durand-Zaleski, Pierre de Truchis, France Lert,Dominique Costagliola, Tabassome Simon, and Anne-Claude Crémieux

Assistance Publique – Hôpitaux de Paris (AP-HP), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Clinical Research Center of East of Paris (CRC-Est), F75012 Paris, France

Université Paris Saclay - Université Versailles Saint-Quentin, Doctoral School of Public Health (EDSP), UMR 1173, F92380 Garches, France

AP-HP, Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Clinical Research Unit of East of Paris (URC-Est), F75012 Paris, France

Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75012 Paris, France

AP-HP, Hôpital Hôtel-Dieu, URC Eco Île-de-France, F75004 Paris, France

Université Paris Diderot, Univ Paris 07, INSERM, ECEVE, UMR 1123, F75019 Paris, France

AP-HP, Hôpital Henri-Mondor, Santé publique, F94010 Créteil, France

AP-HP, Hôpital Raymond-Poincaré, Infectious Disease Department, F92380 Garches, France

Université Paris Sud, Univ Paris 11, INSERM, Centre for research in Epidemiology and population health, U 1018, F94800 Villejuif, France

AP-HP, Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Department of clinical pharmacology and Clinical Research Center of East of Paris (CRC-Est), F75012 Paris, France

Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR 1148, F75018 Paris, France

Université Versailles Saint-Quentin, UMR 1173, F92380 Garches, France

Judith Leblanc, Phone: +33 1 49 28 22 02, Email: rf.phpa@cnalbel.htiduj.

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