Targeted HIV Screening, Emergency DepartmentsDICI-VIHNCT02127424
Targeted Nurse-driven HIV Screening in Emergency Departments
A study testing Nurse-driven HIV targeted screening and Current practice in people with Targeted HIV Screening, Emergency Departments, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Targeted HIV Screening, Emergency Departments
- What is being tested?
- Nurse-driven HIV targeted screening and Current practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148,327 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients at EDs, aged 18-64 years old and not being seen at ED for post exposure prophylaxis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
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, 75012
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Nurse-driven HIV targeted screening, Current practice
- Keywords
- Nurse, Nursing, Screening, HIV, Emergency Service Hospital
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-driven HIV targeted screeningProcedure or surgery
Current practiceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Combination of the nurse-driven HIV targeted screening and the | Experimental | 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. Receives: Procedure: Nurse-driven HIV targeted screening |
| Current practice (no intervention) | Active comparator | Physician-directed HIV diagnostic testing Receives: Procedure: Current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of the expected total duration of the inclusion periods : up to 9 months in each center
Secondary outcomes (7)
Linkage into care of patients with newly diagnosed infection (Follow-up visit with an on-site infectious disease specialist)
Measured: In the 3 months after the HIV screening at the emergency department
Number of new HIV positive tests among the total number of tests
Measured: At the end of the expected total duration of the inclusion periods : up to 9 months in each center
Early detection of HIV (Proportion of patients with CD4>500/mm3, >350/mm3 and >200/mm3, and without HIV-related symptoms at presentation)
Measured: In the 3 months after the HIV screening at the emergency department
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)
Measured: At the end of the expected total duration of the inclusion periods : up to 9 months in each center
Acceptability of the nurse-driven HIV screening by the caregivers (Interviews with nurses, nurse managers, physician doctors and hospital managers)
Measured: Before and after the expected total duration of the inclusion periods : up to 9 months in each center
Cost-effectiveness of the 2 compared strategies
Measured: At the end of the expected total duration of the inclusion periods : up to 9 months in each center
Acceptability of the nurse-driven HIV screening by the patients (additional questionnaire proposed to patients in 4 centers)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Targeted HIV Screening, Emergency DepartmentsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 148,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127424
- Sponsor's protocol ID
- K130601
- Acronym
- DICI-VIH
- Status last verified
- Apr 2016
- First submitted
- 19 Dec 2013
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Cremieux AC; DICI-VIH (Depistage Infirmier CIble du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.
PubMed 29092761Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Cremieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.
PubMed 26831332
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region
- ClinicalTrials.gov ID
- NCT02127424
- Acronym / sponsor ID
- DICI-VIH / K130601
- Keywords
- Nurse, Nursing, Screening, HIV, Emergency Service Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148,327 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of the nurse-driven HIV targeted screening and the | Experimental | Procedure: Nurse-driven HIV targeted screeningNurses 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. |
| Current practice (no intervention) | Active comparator | Procedure: Current practicePhysician-directed HIV diagnostic testing |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients at EDs, aged 18-64 years old and not being seen at ED for post exposure prophylaxis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-driven HIV targeted screening | Procedure or surgery | Combination of the nurse-driven HIV targeted screening and the |
| Current practice | Procedure or surgery | Current practice (no intervention) |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
Acceptability of the nurse-driven HIV screening by the patients (additional questionnaire proposed to patients in 4 centers)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 29092761Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Cremieux AC; DICI-VIH (Depistage Infirmier CIble du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.
- Derived from this study: PubMed 26831332Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Cremieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-driven HIV targeted screening and Current practice in people with Targeted HIV Screening, Emergency Departments, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.