HivDEPISTNCT04298801
Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area? DEPIST Trial (ANRS 14055)
A study testing Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing and Physician-directed diagnostic testing in people with Hiv and Nurse's Role, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area. Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hiv, Nurse's Role
- What is being tested?
- Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing and Physician-directed diagnostic testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2021
- 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 aged 18 to 64 years and visiting a participating ED for reasons other than a potential exposure to HIV within less than 48 hours
Who cannot join
- Not applicable
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area?
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale.
Read more
The aim is to evaluate the impact of a wide implementation of nurse-driven HIV screening by rapid test in key populations combined with usual physician-directed diagnostic testing (intervention strategy) compared to diagnostic testing alone (control strategy) in the usual practice of the EDs.
The strategies will be compared during two periods in 18 EDs of Paris metropolitan area following a stepped-wedge cluster randomized trial.
During intervention period, nurses will suggest performing an HIV rapid test to patients belonging to key populations according to the answers to a self-administered questionnaire.
Read the detailed description
Background:
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations of the National Health Authority (HAS) and expert group support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale in a context where local institutions are taking initiatives to curb the epidemic ("Pour une Ile-de-France sans sida", "Vers Paris sans sida").
Our hypothesis is that nurse-driven HIV screening for key populations can be integrated to the consultants' care pathway as usual practice of the ED and assured over the long term in the Paris metropolitan area; this strategy combined with physician-directed diagnostic testing could reduce undiagnosed infections and help control the epidemic.
Primary objective:
The primary objective is to evaluate the impact of a wide implementation of nurse-driven HIV screening by rapid test in key populations combined with usual physician-directed diagnostic testing (intervention strategy) compared to diagnostic testing alone (control strategy) in the usual practice of the EDs.
Patients aged 18 to 64 years and visiting a participating ED for reasons other than a potential exposure to HIV within less than 48 hours will be included.
The primary outcome is the proportion of new HIV diagnoses among included patients.
Secondary objectives are to :
- evaluate the feasibility of nurse-driven screening and its long-term implementation,
- evaluate the effectiveness of the screening process used by the caregivers, particularly the use of an electronic questionnaire, and by the patients as well as the acceptability,
- compare newly diagnosed HIV+ patients in the two groups in terms of :
- linkage to follow up care,
- proportions of patients who had a CD4 cell count greater or equal to 500 or 350 cells/µL and no HIV-related symptoms and proportions of patients with acute HIV infection.
- estimate through modelling the number of new HIV diagnoses for different levels of coverage of the screening strategy in the Paris metropolitan area.
Methods The strategies will be compared in 18 EDs of Paris metropolitan area during two periods. The start of the intervention strategy will be randomly allocated for each ED following a stepped-wedge cluster randomized trial.
EDs are selected according to the proportion of patients belonging to key populations in the patients they receive (data from two previous studies).
During intervention period, nurses will suggest performing an HIV rapid test to patients belonging to key populations according to the answers to a self-administered questionnaire.
The intervention period will last 3 to 11 months and the control period 0 to 8 months. Patients will participate up to 1 month if a follow-up is needed.
- Conditions
- Hiv, Nurse's Role
- Being tested
- Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing, Physician-directed diagnostic testing
- Keywords
- Emergency service, Hospital, HIV, Mass screening, Nurses, Prevention and control, Key populations, Targeted screening
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testingProcedure or surgery
A self-administered questionnaire on HIV exposure factors will be offered to all patients of ages 18-64 able to complete it. This questionnaire will be available in a paper-based format, electronic format on the patient phone or can be conducted verbally by the nurse. According to the answers, the nurses will suggest performing a rapid test to patients belonging to key populations. A finger-stick rapid HIV test will be performed and results will be disclosed by the nurse assisted by a physician if necessary.
If needed, a follow-up visit with an infectious disease specialist will be scheduled within 72 hours.
Physician-directed diagnostic testingOther
Throughout the intervention, physicians will prescribe HIV tests to patients with HIV-related symptoms, following usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-driven HIV screening for key populations+UD | Experimental | Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing (UD) Receives: Procedure: Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing; Other: Physician-directed diagnostic testing |
| Physician-directed diagnostic testing alone | Active comparator | Not described Receives: Other: Physician-directed diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of new HIV diagnoses among included patients.
Measured: At the end of the expected total duration of the inclusion period: 11 months in each ED
Secondary outcomes (4)
Feasibility of the screening strategy and its implementation
Feasibility of the screening strategy and its implementation based on:
- proportion of distributed and completed self-administered questionnaires among the patients included and among the patients able to participate who were not known to be HIV positive,
- the proportion of rapid tests offered by nurses among patients belonging to key populations,
- the proportion of patients screened by nurses among patients who were offered a rapid test and among patients belonging to high-risk groups .
Measured: At the end of the expected total duration of the inclusion period: 11 months in each ED
Effectiveness of the screening processes used by the caregivers, particularly the integration of the electronic questionnaire, and used by the patients as well as acceptability
Measured: At the end of the expected total duration of the inclusion period: 11 months in each ED
Proportions of patients with a new diagnosis
Proportions of patients with a new diagnosis who had:
- a follow up visit with an infectious disease specialist within 1 month,
- a CD4 cell count greater or equal to 500 or 350/µL and no HIV-related symptoms,
- an acute HIV infection.
Measured: At the end of the expected total duration of the inclusion period: 11 months in each ED
Estimation through modelling of the number of new HIV diagnoses for different levels of coverage of the screening strategy in the Paris metropolitan area.
Measured: At the end of the expected total duration of the inclusion period: 11 months in each ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- 487,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- judith LEBLANC, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298801
- Sponsor's protocol ID
- APHP190502
- Other IDs
- 2019-A02364-53, ANRS 14055
- Acronym
- DEPIST
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Implementation of Nurse-driven HIV Screening for Key Populations in the Emergency Departments Limit Undiagnosed Infections in the Paris Metropolitan Area?
- ClinicalTrials.gov ID
- NCT04298801
- Acronym / sponsor ID
- DEPIST / APHP190502
- Conditions
- Hiv, Nurse's Role
- Keywords
- Emergency service, Hospital, HIV, Mass screening, Nurses, Prevention and control, Key populations, Targeted screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 487,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 Mar 2020 (actual)
- 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.
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale.
The aim is to evaluate the impact of a wide implementation of nurse-driven HIV screening by rapid test in key populations combined with usual physician-directed diagnostic testing (intervention strategy) compared to diagnostic testing alone (control strategy) in the usual practice of the EDs.
The strategies will be compared during two periods in 18 EDs of Paris metropolitan area following a stepped-wedge cluster randomized trial.
During intervention period, nurses will suggest performing an HIV rapid test to patients belonging to key populations according to the answers to a self-administered questionnaire.
Detailed description
Background:
In France, 40% of newly diagnosed HIV infections are concentrated in the Paris metropolitan area.
Two key populations are mainly concerned: persons born in a foreign country and men who have sex with men. The randomized trial ANRS DICI-VIH (2014-2015) showed that nurse-driven HIV screening for key populations, supported by research staff, in 8 emergency departments (EDs) of the region, was effective in addition to diagnostic testing. The strategy advocated by the WHO and the recent French recommendations of the National Health Authority (HAS) and expert group support the proposal of screening for key populations in the EDs. Thus, it is important to evaluate the impact and the feasibility of the implementation of this strategy on a large scale in a context where local institutions are taking initiatives to curb the epidemic ("Pour une Ile-de-France sans sida", "Vers Paris sans sida").
Our hypothesis is that nurse-driven HIV screening for key populations can be integrated to the consultants' care pathway as usual practice of the ED and assured over the long term in the Paris metropolitan area; this strategy combined with physician-directed diagnostic testing could reduce undiagnosed infections and help control the epidemic.
Primary objective:
The primary objective is to evaluate the impact of a wide implementation of nurse-driven HIV screening by rapid test in key populations combined with usual physician-directed diagnostic testing (intervention strategy) compared to diagnostic testing alone (control strategy) in the usual practice of the EDs.
Patients aged 18 to 64 years and visiting a participating ED for reasons other than a potential exposure to HIV within less than 48 hours will be included.
The primary outcome is the proportion of new HIV diagnoses among included patients.
Secondary objectives are to :
- evaluate the feasibility of nurse-driven screening and its long-term implementation,
- evaluate the effectiveness of the screening process used by the caregivers, particularly the use of an electronic questionnaire, and by the patients as well as the acceptability,
- compare newly diagnosed HIV+ patients in the two groups in terms of :
- linkage to follow up care,
- proportions of patients who had a CD4 cell count greater or equal to 500 or 350 cells/µL and no HIV-related symptoms and proportions of patients with acute HIV infection.
- estimate through modelling the number of new HIV diagnoses for different levels of coverage of the screening strategy in the Paris metropolitan area.
Methods The strategies will be compared in 18 EDs of Paris metropolitan area during two periods. The start of the intervention strategy will be randomly allocated for each ED following a stepped-wedge cluster randomized trial.
EDs are selected according to the proportion of patients belonging to key populations in the patients they receive (data from two previous studies).
During intervention period, nurses will suggest performing an HIV rapid test to patients belonging to key populations according to the answers to a self-administered questionnaire.
The intervention period will last 3 to 11 months and the control period 0 to 8 months. Patients will participate up to 1 month if a follow-up is needed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-driven HIV screening for key populations+UD | Experimental | Procedure: Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing, Other: Physician-directed diagnostic testingNurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing (UD) |
| Physician-directed diagnostic testing alone | Active comparator | Other: Physician-directed 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 aged 18 to 64 years and visiting a participating ED for reasons other than a potential exposure to HIV within less than 48 hours
Key exclusion criteria (1 listed)
- Not applicable
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 screening for key populations combined with usual physician-directed diagnostic testingA self-administered questionnaire on HIV exposure factors will be offered to all patients of ages 18-64 able to complete it. This questionnaire will be available in a paper-based format, electronic format on the patient phone or can be conducted verbally by the nurse. According to the answers, the nurses will suggest performing a rapid test to patients belonging to key populations. A finger-stick rapid HIV test will be performed and results will be disclosed by the nurse assisted by a physician if necessary. If needed, a follow-up visit with an infectious disease specialist will be scheduled within 72 hours. | Procedure or surgery | Nurse-driven HIV screening for key populations+UD |
| Physician-directed diagnostic testingThroughout the intervention, physicians will prescribe HIV tests to patients with HIV-related symptoms, following usual practice. | Other | Nurse-driven HIV screening for key populations+UD, Physician-directed diagnostic testing alone |
Primary outcome
Proportion of new HIV diagnoses among included patients.
Time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
4 secondary outcomes
Feasibility of the screening strategy and its implementation
Time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
Effectiveness of the screening processes used by the caregivers, particularly the integration of the electronic questionnaire, and used by the patients as well as acceptability
Time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
Proportions of patients with a new diagnosis
Time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
Estimation through modelling of the number of new HIV diagnoses for different levels of coverage of the screening strategy in the Paris metropolitan area.
Time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
judith LEBLANC principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing and Physician-directed diagnostic testing in people with Hiv and Nurse's Role, run by Assistance Publique - Hôpitaux de Paris.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith LEBLANC, RN, PhD (00 33 1 49 28 22 02, judith.leblanc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of new HIV diagnoses among included patients. (time frame: At the end of the expected total duration of the inclusion period: 11 months in each ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.