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


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Article Info

DATE

2015-12

AUTHORS

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

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). More... »

PAGES

51

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12879-016-1377-6

DOI

http://dx.doi.org/10.1186/s12879-016-1377-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1040352990

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26831332


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28 schema:description 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).
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35 Department
36 French National Health Agency
37 French emergency departments
38 HIV
39 HIV diagnosis
40 HIV exposure
41 HIV patients
42 Paris
43 acceptability
44 access
45 adult patients
46 agencies
47 care settings
48 consultation
49 control
50 course
51 crossover trial
52 current practice
53 diagnosis
54 diagnostic testing
55 disease
56 disease specialists
57 early HIV diagnosis
58 effectiveness
59 emergency department
60 error
61 exposure
62 group
63 health agencies
64 health care settings
65 high-risk group
66 impact
67 implementation
68 inclusion
69 individuals
70 infectious disease specialists
71 information
72 intervention period
73 late HIV diagnosis
74 main secondary objectives
75 metropolitan Paris
76 multicentre
77 national health agencies
78 new HIV diagnoses
79 new HIV patients
80 new diagnosis
81 non-targeted HIV
82 non-targeted screening
83 objective
84 order
85 patients
86 period
87 place
88 power
89 practice
90 primary objective
91 protocol
92 questionnaire
93 rapid test
94 recommendations
95 results
96 sample size
97 screening
98 secondary objective
99 setting
100 size
101 specialist consultation
102 specialists
103 statistical power
104 strategies
105 study
106 survey
107 test
108 testing
109 trials
110 two-period crossover trial
111 type 1 error
112 valuable information
113 visits
114 years
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