Targeted HIV Screening, Emergency Departments Clinical Trial
— DICI-VIHOfficial 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.
| Status | Completed |
| Enrollment | 148327 |
| Est. completion date | December 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - Patients at EDs, aged 18-64 years old and not being seen at ED for post exposure prophylaxis |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| France | Clinical Research Center (Centre de Recherche Clinique de l'Est Parisien, CRC-Est), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris (AP-HP) | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with newly identified HIV infection among the number of 18-64 years patients visited EDs (apart from being seen at ED for prophylaxis after exposure to HIV) during the inclusion periods | At the end of the expected total duration of the inclusion periods : up to 9 months in each center | No | |
| Secondary | Linkage into care of patients with newly diagnosed infection (Follow-up visit with an on-site infectious disease specialist) | In the 3 months after the HIV screening at the emergency department | No | |
| Secondary | Number of new HIV positive tests among the total number of tests | At the end of the expected total duration of the inclusion periods : up to 9 months in each center | No | |
| Secondary | Early detection of HIV (Proportion of patients with CD4>500/mm3, >350/mm3 and >200/mm3, and without HIV-related symptoms at presentation) | In the 3 months after the HIV screening at the emergency department | No | |
| Secondary | 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) | At the end of the expected total duration of the inclusion periods : up to 9 months in each center | No | |
| Secondary | Acceptability of the nurse-driven HIV screening by the caregivers (Interviews with nurses, nurse managers, physician doctors and hospital managers) | Before and after the expected total duration of the inclusion periods : up to 9 months in each center | No | |
| Secondary | Cost-effectiveness of the 2 compared strategies | At the end of the expected total duration of the inclusion periods : up to 9 months in each center | No | |
| Secondary | Acceptability of the nurse-driven HIV screening by the patients (additional questionnaire proposed to patients in 4 centers) | Questionnaire proposed at ED for each patient after the main study questionnaire during inclusion period. Analysis after the expected total duration of the inclusion periods : up to 9 months in each center | No |