The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trialReportar como inadecuado

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* Corresponding author 1 URCEST-CRCEST - Plateforme de recherche clinique de l-est parisien 2 I2C - Infection et inflammation chronique 3 iPLESP - Institut Pierre Louis d-Epidémiologie et de Santé Publique 4 Inserm U1123 - ECEVE - Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables 5 Hôpital Hotêl-Dieu Paris 6 Hôpital Henri Mondor 7 Hôpital Raymond Poincaré 8 CESP - Centre de recherche en épidémiologie et santé des populations 9 LVTS - Laboratoire de Recherche Vasculaire Translationnelle

Abstract : BackgroundIn 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-DesignDICI-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.DiscussionThe 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.

Keywords : Decision support techniques Emergency service Hospital HIV infections Prevention and control

Autor: Judith Leblanc - Alexandra Rousseau - Gilles Hejblum - Isabelle Durand-Zaleski - Pierre De Truchis - France Lert - Dominique Cost



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