Targeted HIV Screening, Emergency Departments Clinical Trial
Official title:
Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening