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

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

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.

rapid test, screening, ELISA, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, access to care

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).

VIKIA®, Biomerieux, Marcy-l'Étoile, France, OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA

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.

The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.

The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.

The number of individuals accepting to participate in the study divided by the total number of individuals proposed.

The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).

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.

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.

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.