Application of HBV Rapid Tests as a Tool for Wide-Use Screening (OPTISCREEN-B)
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| ClinicalTrials.gov Identifier: NCT01767597 |
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Recruitment Status :
Completed
First Posted : January 14, 2013
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B Liver Cirrhosis Carcinoma, Hepatocellular | Other: ELISA testing Other: Rapid testing | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| 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? |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ELISA testing
HBV infection status determined by enzyme-linked immuno-assay (ELISA)
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Other: ELISA testing
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). |
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Experimental: Rapid testing
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
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Other: ELISA testing
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). Other: Rapid testing 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.
Other Names:
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- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.)
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767597
| France | |
| Centre de Santé au Maire-Volta | |
| Paris, France, 75003 | |
| Centre d'examen de santé de la CPAM, antenne rue du Maroc | |
| Paris, France, 75012 | |
| Consultation Policlinique de l'hôpital Saint-Antoine | |
| Paris, France, 75012 | |
| Consultation Voyage de l'hôpital Saint-Antoine | |
| Paris, France, 75012 | |
| CDAG de Belleville | |
| Paris, France, 75020 | |
| Principal Investigator: | Julie Bottero, MD | Hôpital Saint-Antoine |
| Responsible Party: | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
| ClinicalTrials.gov Identifier: | NCT01767597 |
| Other Study ID Numbers: |
IMEA 38 2011-A01603-38 ( Registry Identifier: ANSM ) |
| First Posted: | January 14, 2013 Key Record Dates |
| Results First Posted: | December 13, 2016 |
| Last Update Posted: | December 13, 2016 |
| Last Verified: | October 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee. |
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rapid test screening ELISA hepatitis B virus access to care |
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Hepatitis A Hepatitis B Carcinoma, Hepatocellular Hepatitis Liver Cirrhosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
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