HCVSAHARANCT04286347
HCV, HBV, HIV Testing During Consultation With Anesthesiologist
A study testing HCV, HBV, HIV tests in people with HCV and HBV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- HCV, HBV, HIV tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 27 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient ≥ 18 years-old
- planned surgery in Lariboisiere Hospital, Paris, France
- able to give written informed consent for testing
- proposed to be tested for HIV and HCV if no previous testing found in the medical record
- proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.
Who cannot join
- patient < 18 years-old
- emergency surgery
- unable to give written informed consent for testing: psychiatric diseases, neurologic diseases, …
- a previous testing for HIV and HCV found in the medical record and no obvious risk factor after previous testing
- the patient does not belong to a high-risk group for HBV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
Read the detailed description
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.
The national guidelines recommend at least one HIV testing during life and, more recently, one HCV testing during life to eradicate HCV infection. HBV testing is recommended in patients coming from high prevalence countries, IVDU, prisoners, patients with multiple sexual partners.
The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
HIV testing will use finger-stick whole blood (FSB) INSTI® HIV-1 \& HIV-2 Rapid Antibody Test FSB (BioLytical TM Laboratories Inc., Richmond, B.C., Canada), with a sensitivity 99% [96.3-99.7] and a specificity 99.3%.
HCV testing will use finger-stick whole blood (FSB) Oraquick® HCV test, with a sensitivity and a specificity 99.1 and 100% respectively.
HBV testing will use finger-stick whole blood (FSB) Vikia® HBs Ag test, bioMérieux with a sensitivity and a specificity 96.5 and 99.9% respectively.
- Being tested
- HCV, HBV, HIV tests
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV, HBV, HIV testsProcedure or surgery
HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery
| Study group | Role | What they receive |
|---|---|---|
| HCV, HBV, HIV testing | Experimental | All patient ≥ 18 years-old with a next planned surgery in Lariboisiere Hospital, Paris, France, able to give written informed consent for testing will be proposed to be tested for HIV and HCV if no previous testing found in the medical record and will be proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses. Receives: Procedure: HCV, HBV, HIV tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of HCV, HBV, HIV testing
Feasibility (assessed by the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus)) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France
Measured: Day 0 : during initial consultation, up to 1 hour
Secondary outcomes (2)
Acceptability of HCV, HBV, HIV testing
Acceptability (number of patients who accept to be tested divided by the number of patients who should have been tested according to the national guidelines (for each virus) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France
Measured: Day 0 : during initial consultation, up to 1 hour
Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV, by questionning
Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV during consultation, by direct questionning, with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.
Measured: during Day 0, after the initial consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start5 Aug 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: lack of funding to continue any longer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286347
- Sponsor's protocol ID
- APHP191114
- Other IDs
- 2019-A03071-56
- Acronym
- SAHARA
- Status last verified
- Nov 2021
- First submitted
- 17 Jan 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist
- ClinicalTrials.gov ID
- NCT04286347
- Acronym / sponsor ID
- SAHARA / APHP191114
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding to continue any longer
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 27 Feb 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.
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
Detailed description
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.
The national guidelines recommend at least one HIV testing during life and, more recently, one HCV testing during life to eradicate HCV infection. HBV testing is recommended in patients coming from high prevalence countries, IVDU, prisoners, patients with multiple sexual partners.
The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
HIV testing will use finger-stick whole blood (FSB) INSTI® HIV-1 \& HIV-2 Rapid Antibody Test FSB (BioLytical TM Laboratories Inc., Richmond, B.C., Canada), with a sensitivity 99% [96.3-99.7] and a specificity 99.3%.
HCV testing will use finger-stick whole blood (FSB) Oraquick® HCV test, with a sensitivity and a specificity 99.1 and 100% respectively.
HBV testing will use finger-stick whole blood (FSB) Vikia® HBs Ag test, bioMérieux with a sensitivity and a specificity 96.5 and 99.9% respectively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV, HBV, HIV testing | Experimental | Procedure: HCV, HBV, HIV testsAll patient ≥ 18 years-old with a next planned surgery in Lariboisiere Hospital, Paris, France, able to give written informed consent for testing will be proposed to be tested for HIV and HCV if no previous testing found in the medical record and will be proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient ≥ 18 years-old
- planned surgery in Lariboisiere Hospital, Paris, France
- able to give written informed consent for testing
- proposed to be tested for HIV and HCV if no previous testing found in the medical record
- proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.
Key exclusion criteria (5 listed)
- patient < 18 years-old
- emergency surgery
- unable to give written informed consent for testing: psychiatric diseases, neurologic diseases, …
- a previous testing for HIV and HCV found in the medical record and no obvious risk factor after previous testing
- the patient does not belong to a high-risk group for HBV
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 |
|---|---|---|
| HCV, HBV, HIV testsHCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery | Procedure or surgery | HCV, HBV, HIV testing |
Primary outcome
Feasibility of HCV, HBV, HIV testing
Time frame: Day 0 : during initial consultation, up to 1 hour
Feasibility (assessed by the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus)) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France
2 secondary outcomes
Acceptability of HCV, HBV, HIV testing
Time frame: Day 0 : during initial consultation, up to 1 hour
Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV, by questionning
Time frame: during Day 0, after the initial consultation
Results and safety
The study was stopped early (reason given: lack of funding to continue any longer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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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.
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 HCV, HBV, HIV tests in people with HCV and HBV, 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Dec 2021. 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 was stopped early (reason given: lack of funding to continue any longer). Results are not available in the source record.
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?
Feasibility of HCV, HBV, HIV testing (time frame: Day 0 : during initial consultation, up to 1 hour). 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 2 Dec 2021.