AIDS, Carcinoma, Hepatocellular, Hepatitis B, Hepatitis C, HIV
Conditions
Keywords
rapid test, screening, ELISA, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, access to care
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.
Interventions
OTHERELISA
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).
OTHERRapid 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.
Sponsors
ANRS, Emerging Infectious Diseases
Gilead Sciences
Roche Pharma AG
Mairie de Paris
BioMérieux
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accessibility of Testing Results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access to Care | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion Participating | 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 | 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). |
Countries
France
Participant flow
Recruitment details
Volunteers were recruited from an innercity clinic for persons without healthcare coverage (Médecins du Monde, Paris, France). From February 25, 2013 to June 21, 2013, individuals seeking care at the center were asked to participate.
Pre-assignment details
554 participants were initially screened for eligibility. 150 did not meet inclusion criteria, 16 had a medical condition requiring immediate referral to a specialist, and 61 declined to participate. A total of 327 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Standard Testing With ELISA HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
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). | 162 |
| Rapid Testing HBV, HCV, and HIV infection status determined by a rapid test
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. | 162 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not have serology performed | 47 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | RT failure and no follow-up ELISA | 0 | 3 |
Baseline characteristics
| Characteristic | Rapid Testing | Standard Testing With ELISA | Total |
|---|---|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 12.2 | 39.0 years STANDARD_DEVIATION 12.2 | 37.6 years STANDARD_DEVIATION 12.1 |
| HBV prevalence of birth country High (>8.0%) | 124 participants | 133 participants | 257 participants |
| HBV prevalence of birth country Intermediate (2.0%-8.0%) | 37 participants | 27 participants | 64 participants |
| HBV prevalence of birth country Low (<2.0%) | 1 participants | 2 participants | 3 participants |
| No health insurance plan | 162 participants | 162 participants | 324 participants |
| Sex: Female, Male Female | 63 Participants | 60 Participants | 123 Participants |
| Sex: Female, Male Male | 99 Participants | 102 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 162 | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 | 0 / 162 |
Outcome results
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.
Time frame: Evaluated once, up to 4 months after testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Testing With ELISA | Accessibility of Testing Results | 0.642 proportion of participants |
| Rapid Testing | Accessibility of Testing Results | 0.981 proportion of participants |
Comparison: We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.p-value: <0.001Chi-squared
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.
Time frame: Evaluated once, up to 4 months after testing
Population: Analysis includes only participants with positive HIV, HBV, and/or HCV results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Testing With ELISA | Access to Care | 0.938 proportion of participants |
| Rapid Testing | Access to Care | 0.900 proportion of participants |
p-value: 0.7Chi-squared
Other Pre-specified
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).
Time frame: At testing
Population: Only patients randomized to the rapid testing arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid Testing | Proportion of Rapid Test Failures | 0.074 proportion of participants |
Other Pre-specified
Proportion Participating
The number of individuals accepting to participate in the study divided by the total number of individuals proposed.
Time frame: At testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Testing With ELISA | Proportion Participating | 0.890 proportion of participants |