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

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ClinicalTrials.gov Identifier: NCT01790633
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborators:
ANRS, Emerging Infectious Diseases
Gilead Sciences
Roche Pharma AG
Mairie de Paris
BioMérieux
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
HIV Hepatitis B Hepatitis C Carcinoma, Hepatocellular AIDS Other: ELISA Other: Rapid Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Accessibility of Testing Results [ Time Frame: Evaluated once, up to 4 months after testing ]
    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 :
  1. Access to Care [ Time Frame: Evaluated once, up to 4 months after testing ]
    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:
  1. Proportion Participating [ Time Frame: At testing ]
    The number of individuals accepting to participate in the study divided by the total number of individuals proposed.

  2. Proportion of Rapid Test Failures [ Time Frame: At testing ]
    The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01790633


Locations
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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
ANRS, Emerging Infectious Diseases
Gilead Sciences
Roche Pharma AG
Mairie de Paris
BioMérieux
Investigators
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Principal Investigator: Julie Bottero, MD Hôpital Saint-Antoine
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01790633    
Other Study ID Numbers: IMEA 38B
2012-A01681-42 ( Other Identifier: ANSM )
First Posted: February 13, 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 under the following conditions: (1) interested parties must submit a request for data access to the principal investigator and (2) the request is approved by the Scientific Committee.
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:
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Hepatitis A
Hepatitis C
Hepatitis B
Carcinoma, Hepatocellular
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site