Targeted Nurse-driven HIV Screening in Emergency Departments (DICI-VIH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02127424
First received: December 19, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Targeted HIV Screening, Emergency Departments
Procedure: Nurse-driven HIV targeted screening
Procedure: Current practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 [ Time Frame: At the end of the expected total duration of the inclusion periods : up to 9 months in each center ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Linkage into care of patients with newly diagnosed infection (Follow-up visit with an on-site infectious disease specialist) [ Time Frame: In the 3 months after the HIV screening at the emergency department ] [ Designated as safety issue: No ]
  • Number of new HIV positive tests among the total number of tests [ Time Frame: At the end of the expected total duration of the inclusion periods : up to 9 months in each center ] [ Designated as safety issue: No ]
  • Early detection of HIV (Proportion of patients with CD4>500/mm3, >350/mm3 and >200/mm3, and without HIV-related symptoms at presentation) [ Time Frame: In the 3 months after the HIV screening at the emergency department ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: At the end of the expected total duration of the inclusion periods : up to 9 months in each center ] [ Designated as safety issue: No ]
  • Acceptability of the nurse-driven HIV screening by the caregivers (Interviews with nurses, nurse managers, physician doctors and hospital managers) [ Time Frame: Before and after the expected total duration of the inclusion periods : up to 9 months in each center ] [ Designated as safety issue: No ]
  • Cost-effectiveness of the 2 compared strategies [ Time Frame: At the end of the expected total duration of the inclusion periods : up to 9 months in each center ] [ Designated as safety issue: No ]

Estimated Enrollment: 140000
Study Start Date: June 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination of the nurse-driven HIV targeted screening and the
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, accepting to participate by providing an informed consent and not being seen at ED for post-exposure prophylaxis or unstable medical illness. 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.
Procedure: Nurse-driven HIV targeted screening
Active Comparator: Current practice (no intervention)
Physician-directed HIV diagnostic testing
Procedure: Current practice

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at EDs, aged 18-64 years old and not being seen at ED for post exposure prophylaxis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127424

Contacts
Contact: Judith Leblanc, PhDs, registered nurse 01 49 28 22 02 judith.leblanc@sat.aphp.fr
Contact: Anne-Claude CREMIEUX, MD, PhD 01 47 10 77 58 anne-claude.cremieux@rpc.aphp.fr

Locations
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) Recruiting
Paris, France, 75012
Contact: Hélène PIQUET, Registered nurse    01 71 97 00 02    helene.piquet@sat.aphp.fr   
Contact: Dominique PATERON, MD, PhD    MD, PhD    dominique.pateron@sat.aphp.fr   
Sponsors and Collaborators
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)
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02127424     History of Changes
Other Study ID Numbers: K130601
Study First Received: December 19, 2013
Last Updated: July 25, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France : CCTIRS - Comité Consultatif sur le Traitement de l'Information dans le domaine de la santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nurse
Nursing
Screening
HIV
Emergency Service Hospital

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014