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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Carcinoma, Hepatocellular; Hepatitis C; HIV; AIDS
• Intervention / Treatment: Other: ELISA; Other: Rapid Test

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75011
    • Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard testing with ELISA; HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).	Other: 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.; Other Names: VIKIA®, Biomerieux, Marcy-l'Étoile, France; OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion Participating	The number of individuals accepting to participate in the study divided by the total number of individuals proposed.	At testing
Proportion of Rapid Test Failures	The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).	At testing

Collaborators and Investigators

• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Collaborators: Gilead Sciences; Roche Pharma AG; ANRS, Emerging Infectious Diseases; BioMérieux; Mairie de Paris
• Investigators: Principal Investigator: Julie Bottero, MD, Hôpital Saint-Antoine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: screening; access to care; hepatitis B virus; ELISA; hepatitis C virus; rapid test; human immunodeficiency virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Liver Neoplasms; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Carcinoma, Hepatocellular; Hepatitis A; Hepatitis C
• Other Study ID Numbers: IMEA 38B; 2012-A01681-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.