Hepatitis BOPTISCREEN-BNCT01767597
Application of HBV Rapid Tests as a Tool for Wide-Use Screening
A study testing ELISA testing and Rapid testing in people with Hepatitis B and Liver Cirrhosis, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 5 sites in France.
Trial summary
With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular
- What is being tested?
- ELISA testing and Rapid testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Born in a country of middle or high HBV endemicity
- Parents born in a country of middle or high HBV endemicity
- Travellers or residents from a country of middle or high HBV endemicity
- Blood, organ, tissue, sperm, and/or ovary donners or candidate donners.
- Health-care workers suspected of coming into direct contact with an HBV-infected individual and/or exposed to blood or any biological products from an HBV-infected individual
- Close contact with HBsAg-positive individuals (living in the same household, sexual partner, sharing needles, etc.)
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- Individuals with accidental exposure to HBV
- Individuals with multiple sexual partners
- Men who have sex with men
- Pregnant women
- Hemodialysis
- Individuals requiring immunosuppressive therapy
- Individuals with persistently elevated transaminase levels
- HIV-positive
- Intravenous drug users
Who cannot join
- Age <18 years old
- Not capable of providing informed consent
- Already participated in a multi-center validation of HBV rapid tests
- Having, in their possession, irrefutable results of a prior test for hepatitis B virus
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre de Santé au Maire-Volta
Paris, 75003
Centre d'examen de santé de la CPAM, antenne rue du Maroc
Paris, 75012
Consultation Policlinique de l'hôpital Saint-Antoine
Paris, 75012
Consultation Voyage de l'hôpital Saint-Antoine
Paris, 75012
CDAG de Belleville
Paris, 75020
About this study
Official title: Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?
With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.
In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.
The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.
- Conditions
- Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular
- Being tested
- ELISA testing, Rapid testing
- Keywords
- rapid test, screening, ELISA, hepatitis B virus, access to care
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA testingOther
Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Rapid testingOther
Also called VIKIA®, Biomerieux, Marcy-l'Étoile, France, Quick ProfileTM, Lumiquick, Santa Clara, CA, USA
A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
| Study group | Role | What they receive |
|---|---|---|
| ELISA testing | Active comparator | HBV infection status determined by enzyme-linked immuno-assay (ELISA) Receives: Other: ELISA testing |
| Rapid testing | Experimental | HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). Receives: Other: ELISA testing; Other: Rapid testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Appropriately Seeking Care
Subjects who are considered required to seek further care are as follows:
- those who need HBV vaccination (non-immunized)
- those who are infected with hepatitis B virus (infected)
Of these patients, subjects who have achieved appropriate care are considered as follows:
- non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
- infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)
The percentage of patients appropriately seeking care will be then calculated by the following formula:
((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Gilead Sciences, Roche Pharma AG, Mairie de Paris, BioMérieux
- Responsible party
- Sponsor
- Investigators
- Julie Bottero, MD, Principal investigator, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767597
- Sponsor's protocol ID
- IMEA 38
- Other IDs
- 2011-A01603-38
- Acronym
- OPTISCREEN-B
- Status last verified
- Oct 2016
- First submitted
- 10 Jan 2013
- Last updated
- 13 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.
Publications
Bottero J, Boyd A, Gozlan J, Carrat F, Lemoine M, Rougier H, Varsat B, Boo N, Charlois-Ou C, Collignon A, Cha O, Campa P, Dhotte P, Girard PM, Lacombe K. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):633-9. doi: 10.1097/MEG.0000000000000620.
PubMed 26954517
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?
- ClinicalTrials.gov ID
- NCT01767597
- Acronym / sponsor ID
- OPTISCREEN-B / IMEA 38
- Conditions
- Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular
- Keywords
- rapid test, screening, ELISA, hepatitis B virus, access to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Gilead Sciences, Roche Pharma AG, Mairie de Paris, BioMérieux
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Posted 13 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.
In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.
The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELISA testing | Active comparator | Other: ELISA testingHBV infection status determined by enzyme-linked immuno-assay (ELISA) |
| Rapid testing | Experimental | Other: ELISA testing, Other: Rapid testingHBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Born in a country of middle or high HBV endemicity
- Parents born in a country of middle or high HBV endemicity
- Travellers or residents from a country of middle or high HBV endemicity
- Blood, organ, tissue, sperm, and/or ovary donners or candidate donners.
- Health-care workers suspected of coming into direct contact with an HBV-infected individual and/or exposed to blood or any biological products from an HBV-infected individual
Key exclusion criteria (4 listed)
- Age <18 years old
- Not capable of providing informed consent
- Already participated in a multi-center validation of HBV rapid tests
- Having, in their possession, irrefutable results of a prior test for hepatitis B virus
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 |
|---|---|---|
| ELISA testingEnzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). | Other | ELISA testing, Rapid testing |
| Rapid testingAlso: VIKIA®, Biomerieux, Marcy-l'Étoile, France, Quick ProfileTM, Lumiquick, Santa Clara, CA, USAA rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. | Other | Rapid testing |
Primary outcome
Percentage of Patients Appropriately Seeking Care
Time frame: 6 months
Subjects who are considered required to seek further care are as follows: * those who need HBV vaccination (non-immunized) * those who are infected with hepatitis B virus (infected) Of these patients, subjects who have achieved appropriate care are considered as follows: * non immunized subjects who have initiated HBV vaccination sequence (vaccinated) * infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care) The percentage of patients appropriately seeking care will be then calculated by the following formula: ((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26954517Bottero J, Boyd A, Gozlan J, Carrat F, Lemoine M, Rougier H, Varsat B, Boo N, Charlois-Ou C, Collignon A, Cha O, Campa P, Dhotte P, Girard PM, Lacombe K. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):633-9. doi: 10.1097/MEG.0000000000000620.
- Individual participant dataSharing planned: Yes. Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.
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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.
Julie Bottero, MD principal investigator
Hôpital Saint-Antoine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA testing and Rapid testing in people with Hepatitis B and Liver Cirrhosis, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 5 sites 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 15 inclusion and 4 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 13 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Appropriately Seeking Care (time frame: 6 months). 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 NCT01767597, which also lists 1 linked publication.
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 13 Dec 2016.