title: The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02127424 (29 April 2014).
authors.affiliation: 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. judith.leblanc@aphp.fr.|Université Paris Saclay - Université Versailles Saint-Quentin, Doctoral School of Public Health (EDSP), UMR 1173, F92380, Garches, France. judith.leblanc@aphp.fr.
authors.forename: Judith
authors.initials: J
authors.lastname: Leblanc
authors.affiliation: AP-HP, Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Clinical Research Unit of East of Paris (URC-Est), F75012, Paris, France. alexandra.rousseau@aphp.fr.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Rousseau
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75012, Paris, France. gilles.hejblum@inserm.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Hejblum
authors.affiliation: AP-HP, Hôpital Hôtel-Dieu, URC Eco Île-de-France, F75004, Paris, France. isabelle.durand-zaleski@aphp.fr.|Université Paris Diderot, Univ Paris 07, INSERM, ECEVE, UMR 1123, F75019, Paris, France. isabelle.durand-zaleski@aphp.fr.|AP-HP, Hôpital Henri-Mondor, Santé publique, F94010, Créteil, France. isabelle.durand-zaleski@aphp.fr.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.affiliation: AP-HP, Hôpital Raymond-Poincaré, Infectious Disease Department, F92380, Garches, France. p.de-truchis@aphp.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: de Truchis
authors.affiliation: Université Paris Sud, Univ Paris 11, INSERM, Centre for research in Epidemiology and population health, U 1018, F94800, Villejuif, France. france.lert@inserm.fr.
authors.forename: France
authors.initials: F
authors.lastname: Lert
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75012, Paris, France. dominique.costagliola@iplesp.upmc.fr.
authors.forename: Dominique
authors.initials: D
authors.lastname: Costagliola
authors.affiliation: 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. tabassome.simon@aphp.fr.|Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR 1148, F75018, Paris, France. tabassome.simon@aphp.fr.
authors.forename: Tabassome
authors.initials: T
authors.lastname: Simon
authors.affiliation: AP-HP, Hôpital Raymond-Poincaré, Infectious Disease Department, F92380, Garches, France. anne-claude.cremieux@aphp.fr.|Université Versailles Saint-Quentin, UMR 1173, F92380, Garches, France. anne-claude.cremieux@aphp.fr.
authors.forename: Anne-Claude
authors.initials: AC
authors.lastname: Crémieux
mesh_terms: D000293:Adolescent; D000328:Adult; D003362:Cost-Benefit Analysis; D018592:Cross-Over Studies; D042241:Early Diagnosis; D004636:Emergency Service, Hospital; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000191:economics; D008875:Middle Aged; D009726:Nurses; D010297:Paris; D010820:Physicians; D012017:Referral and Consultation; D012747:Sexual Partners; D015819:Substance Abuse, Intravenous; D011795:Surveys and Questionnaires; D055815:Young Adult
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