HIV InfectionsOPDEPNCT03088995
Pilot Study of HIV and Hepatitis B and C Screening in Surgery
An observational study of HIV Infections and Hepatitis B, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial summary
The purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hepatitis B, Hepatitis C
- What is being tested?
- Pilot study
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Dec 2017
- Phase
- Observational
- 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
Study population: Pre-operative screening for HIV and viral hepatitis B and C: Pilot study in stomatology, Pitie salpetriere hospital. This study is part of a study to evaluate routine care. Screening for HIV and viral hepatitis B and C is a common clinical practice, and the populations on which it is practiced are both populations with risk behaviors and the general population. The evaluation of the strategy for scaling up HIV testing in healthcare facilities is broadly based, including a report by the National AIDS Council and the HAS and WHO recommendations that call for enlargement Of the existing screening offer.
Who may be able to join
- men and women
- -> 18 years
- address for surgical intervention under general anesthesia in the Department of Stomatology of Pitié-Salpêtrière.
- have given their oral consent during the consultation of anesthesia.
Who cannot join
- refusal of screening
- any patient already known to be HIV-positive / HBV / HCV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-operative Screening for HIV and Viral Hepatitis B and C: Pilot Study in Stomatology
The purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital.
Patients undergoing treatment in Stomatology have particular areas at risk for the infections we are looking for: young patients, precarious situation, drug use, migrants ...
The aim is to evaluate the conditions for a generalization of screening in the framework of the preoperative assessment.
Read the detailed description
The HIV epidemic is still active in France, with 7 000 to 8 000 new infections per year.There are an estimated 150,000 people living with HIV in France. Data from the hidden epidemic show that:
- approximately 30,000 patients are unaware of their HIV status
- that the Ile de France area accounts for 44% of new infections. For over 20 years, the patient-initiated HIV counseling and testing system has helped thousands of people to know about their HIV status, but coverage for counseling and testing low. In 2007, WHO and UNAIDS published guidance on provider-initiated HIV counseling and testing in health facilities to improve acceptance and access to prevention, treatment And care.
It is in this context that, in France, the National Plan for the Fight against AIDS and Sexually Transmitted Infections (STI) 2010-2014 recommended strengthening the screening strategies, making it its Public Health dimension, Reintegrating into an overall preventive approach. The expected benefits of routine screening would thus be individual as well as collective: routine screening could be a means of controlling infection by modifying risk behaviors, it could be a preventive tool by allowing earlier diagnosis Of the disease, it could be associated with an evolution of the management and the prognosis of the infection by allowing the initiation of an antiretroviral treatment in the acute phase of the infection. In 2011, the Ministry of Health systematized the screening proposal to the entire population, considering this strategy as cost-effective with a direct individual benefit and a Public Health benefit by reducing the number of transmission. In this Plan, health authorities recommend that hospital doctors and city general practitioners prescribe HIV testing much more widely than they do, while targeting persons belonging to an identified risk group and those Low "apparent" risk.
Screening remains a critical problem in the management with 20-30% of patients diagnosed at a late stage (CD4 <200 / mm3).
According to the Institute of Health Watch, about 100 000 hepatitis C viral patients are undiagnosed in France with differences in prevalence according to sex and age.
For hepatitis B, 55% of chronic carriers of the HBs antigen do not know their status, ie about 160 000 people in France.
The recommendations of the 2014 expert report (Dhumeaux report) have changed screening not only because of the high proportion of patients not aware of their serological status, but also of recent advances in the treatment of these two infections.
For hepatitis C, the availability of more effective, better tolerated and shorter treatments reinforces the need to screen, monitor and eventually treat the patient according to treatment recommendations.
The expert report proposes to:
- Continue targeted screening based on the risk factors for contamination (drug addiction, sexual exposure, originating from countries with high endemicity, etc.) and to inform the general population and general practitioners
- Expand the screening strategies to the following populations: men aged 18 to 60, pregnant women from the first prenatal consultation, by regularly evaluating these strategies
- Associate in all cases the research of the three viruses HBV, HCV and HIV, taking into account the epidemiological similarities, the possibility and the interest of grouped tests.
The success of screening programs depends on a number of fundamental principles including:
- Targeted disease must be associated with high morbidity and mortality
- The screening test must be safe, acceptable and inexpensive
- Effective treatment must be available These 3 principles are just for HIV, viral hepatitis B and C. HIV is associated with an increase in morbidity and mortality in the absence of antiretroviral treatment. The serological test is safe, acceptable and inexpensive. Antiretroviral therapy is available, and in 2015, French and international guidelines provide universal treatment regardless of the stage of infection.
Hepatitis C is associated with increased morbidity and mortality in the absence of treatment. The disease progresses to cirrhosis, hepatocellular carcinoma and terminal liver disease, which are responsible for high morbidity and may also be associated with severe extrahepatic manifestations. A serological test is available, safe, acceptable and inexpensive. The antiviral treatment is available with new strategies and new molecules allowing a cure in more than 95% of the patients according to the stage of the disease.
Hepatitis B is associated with increased morbidity and mortality in the absence of treatment. The serological test is safe, acceptable and inexpensive. The disease progresses to cirrhosis, hepatocellular carcinoma and terminal liver disease, which are responsible for high morbidity. Antiviral treatment is available and helps control long-term infection.
These 3 pathologies, targets of our screening, respond to these fundamental principles.
The investigators hypothesize that pre-operative screening will increase the number of HIV-positive people screened and decrease the number of people who have been treated late for their HIV, HBV and / or HCV infection. The persons detected in this way could be taken care of in optimal care channels more precisely. Moreover, knowledge of their seropositivity should modify their behavior and favor the rupture of the transmission. The proposed methodology is based on the development of a screening strategy for HIV and B and C viral hepatitis by serology, which is systematically proposed by the anesthesiologist to all persons over the age of 18 who are undergoing surgery under anesthesia In Stomatology. This study is based on the formalization of close and effective functional links between the Department of Infectious Diseases and Tropical Diseases, the Department of Stomatology and the Laboratory of Virology.
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C
- Being tested
- Pilot study
- Medical subject headings
- HIV Infections, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot studyDiagnostic test
Pilot study of HIV and viral hepatitis B and C screening in surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Measure of HIV infection assessed by serology using ARCHITECT Ag/Ac VIH Combo kit
Measured: 12 months
Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Measure of viral hepatitis B infection assessed by serology using ARCHITECT AgHBs qualitative II kit
Measured: 12 months
Measure of viral hepatitis C infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Measure of viral hepatitis C infection assessed by serology using ARCHITECT Anti-HCV kit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Pourcher-martinez, MD, PhD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088995
- Sponsor's protocol ID
- CREPATS 006
- Acronym
- OPDEP
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Screening for HIV and Viral Hepatitis B and C: Pilot Study in Stomatology
- ClinicalTrials.gov ID
- NCT03088995
- Acronym / sponsor ID
- OPDEP / CREPATS 006
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Mar 2017 (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 purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital.
Patients undergoing treatment in Stomatology have particular areas at risk for the infections we are looking for: young patients, precarious situation, drug use, migrants ...
The aim is to evaluate the conditions for a generalization of screening in the framework of the preoperative assessment.
Detailed description
The HIV epidemic is still active in France, with 7 000 to 8 000 new infections per year.There are an estimated 150,000 people living with HIV in France. Data from the hidden epidemic show that:
- approximately 30,000 patients are unaware of their HIV status
- that the Ile de France area accounts for 44% of new infections. For over 20 years, the patient-initiated HIV counseling and testing system has helped thousands of people to know about their HIV status, but coverage for counseling and testing low. In 2007, WHO and UNAIDS published guidance on provider-initiated HIV counseling and testing in health facilities to improve acceptance and access to prevention, treatment And care.
It is in this context that, in France, the National Plan for the Fight against AIDS and Sexually Transmitted Infections (STI) 2010-2014 recommended strengthening the screening strategies, making it its Public Health dimension, Reintegrating into an overall preventive approach. The expected benefits of routine screening would thus be individual as well as collective: routine screening could be a means of controlling infection by modifying risk behaviors, it could be a preventive tool by allowing earlier diagnosis Of the disease, it could be associated with an evolution of the management and the prognosis of the infection by allowing the initiation of an antiretroviral treatment in the acute phase of the infection. In 2011, the Ministry of Health systematized the screening proposal to the entire population, considering this strategy as cost-effective with a direct individual benefit and a Public Health benefit by reducing the number of transmission. In this Plan, health authorities recommend that hospital doctors and city general practitioners prescribe HIV testing much more widely than they do, while targeting persons belonging to an identified risk group and those Low "apparent" risk.
Screening remains a critical problem in the management with 20-30% of patients diagnosed at a late stage (CD4 <200 / mm3).
According to the Institute of Health Watch, about 100 000 hepatitis C viral patients are undiagnosed in France with differences in prevalence according to sex and age.
For hepatitis B, 55% of chronic carriers of the HBs antigen do not know their status, ie about 160 000 people in France.
The recommendations of the 2014 expert report (Dhumeaux report) have changed screening not only because of the high proportion of patients not aware of their serological status, but also of recent advances in the treatment of these two infections.
For hepatitis C, the availability of more effective, better tolerated and shorter treatments reinforces the need to screen, monitor and eventually treat the patient according to treatment recommendations.
The expert report proposes to:
- Continue targeted screening based on the risk factors for contamination (drug addiction, sexual exposure, originating from countries with high endemicity, etc.) and to inform the general population and general practitioners
- Expand the screening strategies to the following populations: men aged 18 to 60, pregnant women from the first prenatal consultation, by regularly evaluating these strategies
- Associate in all cases the research of the three viruses HBV, HCV and HIV, taking into account the epidemiological similarities, the possibility and the interest of grouped tests.
The success of screening programs depends on a number of fundamental principles including:
- Targeted disease must be associated with high morbidity and mortality
- The screening test must be safe, acceptable and inexpensive
- Effective treatment must be available These 3 principles are just for HIV, viral hepatitis B and C. HIV is associated with an increase in morbidity and mortality in the absence of antiretroviral treatment. The serological test is safe, acceptable and inexpensive. Antiretroviral therapy is available, and in 2015, French and international guidelines provide universal treatment regardless of the stage of infection.
Hepatitis C is associated with increased morbidity and mortality in the absence of treatment. The disease progresses to cirrhosis, hepatocellular carcinoma and terminal liver disease, which are responsible for high morbidity and may also be associated with severe extrahepatic manifestations. A serological test is available, safe, acceptable and inexpensive. The antiviral treatment is available with new strategies and new molecules allowing a cure in more than 95% of the patients according to the stage of the disease.
Hepatitis B is associated with increased morbidity and mortality in the absence of treatment. The serological test is safe, acceptable and inexpensive. The disease progresses to cirrhosis, hepatocellular carcinoma and terminal liver disease, which are responsible for high morbidity. Antiviral treatment is available and helps control long-term infection.
These 3 pathologies, targets of our screening, respond to these fundamental principles.
The investigators hypothesize that pre-operative screening will increase the number of HIV-positive people screened and decrease the number of people who have been treated late for their HIV, HBV and / or HCV infection. The persons detected in this way could be taken care of in optimal care channels more precisely. Moreover, knowledge of their seropositivity should modify their behavior and favor the rupture of the transmission. The proposed methodology is based on the development of a screening strategy for HIV and B and C viral hepatitis by serology, which is systematically proposed by the anesthesiologist to all persons over the age of 18 who are undergoing surgery under anesthesia In Stomatology. This study is based on the formalization of close and effective functional links between the Department of Infectious Diseases and Tropical Diseases, the Department of Stomatology and the Laboratory of Virology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-operative screening for HIV and viral hepatitis B and C: Pilot study in stomatology, Pitie salpetriere hospital. This study is part of a study to evaluate routine care. Screening for HIV and viral hepatitis B and C is a common clinical practice, and the populations on which it is practiced are both populations with risk behaviors and the general population. The evaluation of the strategy for scaling up HIV testing in healthcare facilities is broadly based, including a report by the National AIDS Council and the HAS and WHO recommendations that call for enlargement Of the existing screening offer.
Key inclusion criteria (4 listed)
- men and women
- -> 18 years
- address for surgical intervention under general anesthesia in the Department of Stomatology of Pitié-Salpêtrière.
- have given their oral consent during the consultation of anesthesia.
Key exclusion criteria (2 listed)
- refusal of screening
- any patient already known to be HIV-positive / HBV / HCV.
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 |
|---|---|---|
| Pilot studyPilot study of HIV and viral hepatitis B and C screening in surgery | Diagnostic test | – |
Primary outcome
Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Time frame: 12 months
Measure of HIV infection assessed by serology using ARCHITECT Ag/Ac VIH Combo kit
Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Time frame: 12 months
Measure of viral hepatitis B infection assessed by serology using ARCHITECT AgHBs qualitative II kit
Measure of viral hepatitis C infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment
Time frame: 12 months
Measure of viral hepatitis C infection assessed by serology using ARCHITECT Anti-HCV kit
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 8 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Valérie Pourcher-martinez, MD, PhD principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis B, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida 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 4 inclusion and 2 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 8 Dec 2017. 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?
Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment (time frame: 12 months). The study lists 3 primary outcomes in all. 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 8 Dec 2017.