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
  Purpose

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.


Condition Intervention
HIV
Hepatitis B
Hepatitis C
Carcinoma, Hepatocellular
AIDS
Other: ELISA
Other: Rapid Test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard testing with ELISA
HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
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).
Experimental: Rapid testing
HBV, HCV, and HIV infection status determined by a rapid test
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790633

Locations
France
Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)
Paris, France, 75011
Sponsors and Collaborators
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
Investigators
Principal Investigator: Julie Bottero, MD Hôpital Saint-Antoine
  More Information

Additional Information:
Publications:

Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01790633     History of Changes
Other Study ID Numbers: IMEA 38B, 2012-A01681-42
Study First Received: February 7, 2013
Last Updated: July 22, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
rapid test
screening
ELISA
hepatitis B virus
hepatitis C virus
human immunodeficiency virus
access to care

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014