Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01790633|
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Proportion Participating [ Time Frame: At testing ]The number of individuals accepting to participate in the study divided by the total number of individuals proposed.
- 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).
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
|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|