Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular, AIDS

Intervention / Treatment
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* Other: ELISA
* Other: Rapid Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard testing with ELISA<br>HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA). | Other: ELISA<br>* 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).<br>|
| Experimental: Rapid testing<br>HBV, HCV, and HIV infection status determined by a rapid test | Other: Rapid Test<br>* 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.<br>* Other names: OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accessibility of Testing Results | The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals. | Evaluated once, up to 4 months after testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access to Care | The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals. | Evaluated once, up to 4 months after testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELISA, human immunodeficiency virus, access to care, rapid test, screening, hepatitis B virus, hepatitis C virus