Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
Biomerieux
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT01790633
First received: February 7, 2013
Last updated: July 22, 2013
Last verified: July 2013

February 7, 2013
July 22, 2013
March 2013
July 2013   (final data collection date for primary outcome measure)
Accessibility of testing results [ Time Frame: Evaluated once, up to 4 months after testing ] [ Designated as safety issue: No ]
The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.
Same as current
Complete list of historical versions of study NCT01790633 on ClinicalTrials.gov Archive Site
Access to care [ Time Frame: Evaluated once, up to 4 months after testing ] [ Designated as safety issue: No ]
The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.
Same as current
  • Proportion participating [ Time Frame: At testing ] [ Designated as safety issue: No ]
    The number of individuals accepting to participate in the study divided by the total number of individuals proposed.
  • Proportion accepting to test [ Time Frame: At testing ] [ Designated as safety issue: No ]
    The number individuals accepting to test divided by the total number of individuals accepting to participate in the study.
  • Proportion of rapid test failures [ Time Frame: At testing ] [ Designated as safety issue: No ]
    The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).
Same as current
 
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations

This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).

Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.

The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • HIV
  • Hepatitis B
  • Hepatitis C
  • Carcinoma, Hepatocellular
  • AIDS
  • Other: ELISA
    Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).
  • Other: Rapid Test
    A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.
    Other Names:
    • VIKIA®, Biomerieux, Marcy-l'Étoile, France
    • OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA
  • Active Comparator: Standard testing with ELISA
    HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
    Intervention: Other: ELISA
  • Experimental: Rapid testing
    HBV, HCV, and HIV infection status determined by a rapid test
    Intervention: Other: Rapid Test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
October 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age
  • Seeking care at the CASO MDM health care center
  • Accept to be followed at Saint-Antoine Hospital in the event of a positive test.

Exclusion Criteria:

  • Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV
  • Already has been tested (must give any of the following as evidence):

    • results from HBV and HCV and HIV tests dating at least 3 months back
    • results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01790633
IMEA 38B, 2012-A01681-42
Yes
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
  • French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Gilead Sciences
  • Roche Pharma AG
  • Mairie de Paris
  • Biomerieux
Principal Investigator: Julie Bottero, MD Hôpital Saint-Antoine
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP