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

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

doi:10.1186/s12879-016-1377-6

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.Trial registrationClinicalTrials.gov: NCT02127424 (29 April 2014).

Highlights

In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings
Additional analyses Factors associated with patient refusal of nurse-driven targeted HIV screening In half the centres, all patients who have completed the DICI-VIH questionnaire, are at risk of HIV exposure and eligible for nurse-driven targeted HIV screening are considered over randomly selected 32-h observation periods of Emergency Departments (EDs) activity during 7 consecutive days
The patient characteristics reported in the DICI-VIH questionnaire, history of HIV testing and perceived HIV risk will be compared between patients refusing to be tested and patients accepting the rapid test in the context of nurse-driven targeted HIV screening

Summary

Introduction

In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. In 2010, mirroring what had already been suggested in other countries [10, 11], national recommendations encouraged French healthcare staff to conduct non-targeted screening among the 15 to 70 year old population, in order to reach patients who wouldn’t voluntarily get tested [12, 13]. In this context, nurses were given the possibility of offering, performing and delivering the result of an HIV rapid test [14]

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Conclusion