Application of HBV Rapid Tests as a Tool for Wide-Use Screening (OPTISCREEN-B)

October 21, 2016 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75003
        • Centre de Santé au Maire-Volta
      • Paris, France, 75012
        • 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, 75020
        • CDAG de Belleville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ELISA testing
HBV infection status determined by enzyme-linked immuno-assay (ELISA)
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).
Experimental: Rapid testing
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
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:
  • VIKIA®, Biomerieux, Marcy-l'Étoile, France
  • Quick ProfileTM, Lumiquick, Santa Clara, CA, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Collaborators

Gilead Sciences
Roche Pharma AG
ANRS, Emerging Infectious Diseases
BioMérieux
Mairie de Paris

Investigators

  • Principal Investigator: Julie Bottero, MD, Hôpital Saint-Antoine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 14, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 38
  • 2011-A01603-38 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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