Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Hepatitis B Clinical Trial

— OPTISCREEN-B  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767597
• Other study ID #: IMEA 38
• Secondary ID: 2011-A01603-38
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: January 10, 2013
• Start date: February 2012

Study information

• Verified date: January 2013
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Cirrhosis

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	CDAG de Belleville	Paris
France	Centre d'examen de santé de la CPAM, antenne rue du Maroc	Paris
France	Centre de Santé au Maire-Volta	Paris
France	Consultation Policlinique de l'hôpital Saint-Antoine	Paris
France	Consultation Voyage de l'hôpital Saint-Antoine	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	BioMérieux, French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS), Gilead Sciences, Mairie de Paris, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No

External Links

•   OPTISCREEN B study website