Trial Outcomes & Findings for Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (NCT NCT01790633)
NCT ID: NCT01790633
Last Updated: 2016-12-13
Results Overview
The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
327 participants
Primary outcome timeframe
Evaluated once, up to 4 months after testing
Results posted on
2016-12-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
164
|
|
Overall Study
COMPLETED
|
115
|
159
|
|
Overall Study
NOT COMPLETED
|
48
|
5
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Did not have serology performed
|
47
|
0
|
|
Overall Study
RT failure and no follow-up ELISA
|
0
|
3
|
Baseline Characteristics
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
Baseline characteristics by cohort
| Measure |
Standard Testing With ELISA
n=162 Participants
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).
|
Rapid Testing
n=162 Participants
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.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
HBV prevalence of birth country
Low (<2.0%)
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
HBV prevalence of birth country
Intermediate (2.0%-8.0%)
|
27 participants
n=5 Participants
|
37 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
HBV prevalence of birth country
High (>8.0%)
|
133 participants
n=5 Participants
|
124 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
No health insurance plan
|
162 participants
n=5 Participants
|
162 participants
n=7 Participants
|
324 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated once, up to 4 months after testingThe number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.
Outcome measures
| Measure |
Standard Testing With ELISA
n=162 Participants
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).
|
Rapid Testing
n=162 Participants
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.
|
|---|---|---|
|
Accessibility of Testing Results
|
0.642 proportion of participants
|
0.981 proportion of participants
|
SECONDARY outcome
Timeframe: Evaluated once, up to 4 months after testingPopulation: Analysis includes only participants with positive HIV, HBV, and/or HCV results.
The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.
Outcome measures
| Measure |
Standard Testing With ELISA
n=16 Participants
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).
|
Rapid Testing
n=20 Participants
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.
|
|---|---|---|
|
Access to Care
|
0.938 proportion of participants
|
0.900 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At testingThe number of individuals accepting to participate in the study divided by the total number of individuals proposed.
Outcome measures
| Measure |
Standard Testing With ELISA
n=554 Participants
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).
|
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.
|
|---|---|---|
|
Proportion Participating
|
0.890 proportion of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At testingPopulation: Only patients randomized to the rapid testing arm.
The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).
Outcome measures
| Measure |
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).
|
Rapid Testing
n=162 Participants
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.
|
|---|---|---|
|
Proportion of Rapid Test Failures
|
—
|
0.074 proportion of participants
|
Adverse Events
Standard Testing With ELISA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rapid Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julie Bottero
Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine
Phone: +33 1 49 28 04 24
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place