Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
NCT ID: NCT01790633
Last Updated: 2016-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
327 participants
INTERVENTIONAL
2013-02-28
2013-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Standard testing with ELISA
HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
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).
Rapid testing
HBV, HCV, and HIV infection status determined by a rapid test
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.
Interventions
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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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Gilead Sciences
INDUSTRY
Roche Pharma AG
INDUSTRY
Mairie de Paris
UNKNOWN
BioMérieux
INDUSTRY
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Principal Investigators
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Julie Bottero, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Antoine
Locations
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Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)
Paris, , France
Countries
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References
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Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol. 2013 Mar;58(3):473-8. doi: 10.1016/j.jhep.2012.11.016. Epub 2012 Nov 23.
Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.
Other Identifiers
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2012-A01681-42
Identifier Type: OTHER
Identifier Source: secondary_id
IMEA 38B
Identifier Type: -
Identifier Source: org_study_id