Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)
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.
Other: Rapid Test
|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|
- 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.
- 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.
- 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).
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Standard testing with ELISA
HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790633
|Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)|
|Paris, France, 75011|
|Principal Investigator:||Julie Bottero, MD||Hôpital Saint-Antoine|