Clinical trial NCT01790633: Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis B
Hepatitis C
Carcinoma, Hepatocellular
AIDS
Keywords: rapid test
screening
ELISA
hepatitis B virus
hepatitis C virus
human immunodeficiency virus
access to care
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
Collaborators: name: ANRS, Emerging Infectious Diseases
name: Gilead Sciences
name: Roche Pharma AG
name: Mairie de Paris
name: BioMérieux
First posted: 2013-02-13
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accessibility of Testing Results
timeFrame: Evaluated once, up to 4 months after testing
Secondary outcomes:
measure: Access to Care
timeFrame: Evaluated once, up to 4 months after testing
Other outcomes:
measure: Proportion Participating
timeFrame: At testing
measure: Proportion of Rapid Test Failures
timeFrame: At testing
Locations:
city: Paris
country: France
facility: Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)
Study officials:
affiliation: Hôpital Saint-Antoine
name: Julie Bottero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.