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

HIV Clinical Trial

— OPTISCREEN-III  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01790633
• Other study ID #: IMEA 38B
• Secondary ID: 2012-A01681-42
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2013
• Last updated: July 22, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• AIDS
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	BioMérieux, French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS), Gilead Sciences, Mairie de Paris, Roche Pharma AG

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

Cazein F, Barin F, Le Strat Y, Pillonel J, Le Vu S, Lot F, Thierry D, Meffre C, Semaille C. Prevalence and characteristics of individuals with undiagnosed HIV infection in France: evidence from a survey on hepatitis B and C seroprevalence. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):e114-7. doi: 10.1097/QAI.0b013e318256b3fd. — View Citation

European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. Erratum in: J Hepatol. 2013 Jan;58(1):201. Janssen, Harry [corrected to Janssen, Harry L A]. — View Citation

European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011 Aug;55(2):245-64. doi: 10.1016/j.jhep.2011.02.023. Epub 2011 Mar 1. — View Citation

Hutchinson AB, Branson BM, Kim A, Farnham PG. A meta-analysis of the effectiveness of alternative HIV counseling and testing methods to increase knowledge of HIV status. AIDS. 2006 Aug 1;20(12):1597-604. Review. — View Citation

Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW; Centers for Disease Control and Prevention (CDC). Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Recomm Rep. 2008 Sep 19;57(RR-8):1-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion participating	The number of individuals accepting to participate in the study divided by the total number of individuals proposed.	At testing	No
Other	Proportion accepting to test	The number individuals accepting to test divided by the total number of individuals accepting to participate in the study.	At testing	No
Other	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	No
Primary	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	No
Secondary	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	No

External Links

•   OPTISCREEN B study website