Targeted Nurse-driven HIV Screening in Emergency Departments
Condition: Targeted HIV Screening, Emergency Departments
MeSH terms: Emergencies
Study type: Interventional

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.
    

Detailed description: 
      Background :

      Despite easy and free access to HIV testing services and 5 million of tests per year
      performed, late diagnosis remains common in France with one-third of HIV infections diagnosed
      associated with AIDS or CD4 lymphocyte counts of less than 200/μL. To improve early
      detection, the national health agency has promoted non-targeted HIV screening in health care
      settings, including emergency departments (EDs), in addition to diagnostic testing routinely
      performed by physicians. In our previous survey conducted in 2009-2010 in 29 EDs of the
      metropolitan Paris area, 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.

      Primary objective :

      The aim of the present study is to compare the efficacy of two 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 (physician-directed HIV diagnostic
      testing).

      The main outcome measure is the number of patients with newly identified HIV infection among
      the number of 18-64 years patients visited EDs (apart from being seen for prophylaxis after
      exposure to HIV) during the inclusion periods.

      Secondary objectives :

      The linkage into care of patients with newly diagnosed infection, the number of new HIV
      positive tests among the total number of tests, and the early detection will be compared.

      The 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) and its acceptability caregivers in each ED will be evaluated as well as its
      cost-effectiveness.

      Methods :

      Multicenter trial with cluster randomization and cross-over The 2 strategies will be compared
      during 2 randomly assigned periods separated by a month (cluster randomization and
      cross-over). 8 750 patients per ED and per period are expected with 8 EDs (cf. statistical
      plan).

      The study will be performed in 8 EDs of metropolitan Paris, an area in which half of France's
      new HIV patients are diagnosed. The centers will be selected based on the high proportion of
      patients at high risk visiting the EDs.

      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. 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.

      Perspective :

      This project will allow defining the benefit of nurse-driven HIV targeted screening in EDs
      and its potential utility to improve HIV screening in France.
    

Intervention name(s): Nurse-driven HIV targeted screening; Current practice
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Nurse; Nursing; Screening; HIV; Emergency Service Hospital