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Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)

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ClinicalTrials.gov Identifier: NCT01790633
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
BioMérieux
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions HIV
Hepatitis B
Hepatitis C
Carcinoma, Hepatocellular
AIDS
Interventions Other: ELISA
Other: Rapid Test
Enrollment 327
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.
Arm/Group Title Standard Testing With ELISA Rapid Testing
Hide Arm/Group Description

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).

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.

Period Title: Overall Study
Started 163 164
Completed 115 159
Not Completed 48 5
Reason Not Completed
Protocol Violation             1             2
Did not have serology performed             47             0
RT failure and no follow-up ELISA             0             3
Arm/Group Title Standard Testing With ELISA Rapid Testing Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 162 162 324
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 162 participants 324 participants
39.0  (12.2) 37.0  (12.2) 37.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 162 participants 324 participants
Female
60
  37.0%
63
  38.9%
123
  38.0%
Male
102
  63.0%
99
  61.1%
201
  62.0%
HBV prevalence of birth country  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants 162 participants 324 participants
Low (<2.0%) 2 1 3
Intermediate (2.0%-8.0%) 27 37 64
High (>8.0%) 133 124 257
No health insurance plan  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants 162 participants 324 participants
162 162 324
1.Primary Outcome
Title Accessibility of Testing Results
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Testing With ELISA Rapid Testing
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 162 162
Measure Type: Number
Unit of Measure: proportion of participants
0.642 0.981
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Testing With ELISA, Rapid Testing
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value adjustments for multiple comparisons were not necessary. Significance was determined using P < 0.05
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Access to Care
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes only participants with positive HIV, HBV, and/or HCV results.
Arm/Group Title Standard Testing With ELISA Rapid Testing
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: proportion of participants
0.938 0.900
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Testing With ELISA, Rapid Testing
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments P-value adjustments for multiple comparisons were not necessary. Significance was determined using P < 0.05
Method Chi-squared
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Proportion Participating
Hide Description The number of individuals accepting to participate in the study divided by the total number of individuals proposed.
Time Frame At testing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screened for Eligibility
Hide Arm/Group Description:
Individuals who were screened for eligibility, prior to being considered for randomization.
Overall Number of Participants Analyzed 554
Measure Type: Number
Unit of Measure: proportion of participants
0.890
4.Other Pre-specified Outcome
Title Proportion of Rapid Test Failures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients randomized to the rapid testing arm.
Arm/Group Title Standard Testing With ELISA Rapid Testing
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 162
Measure Type: Number
Unit of Measure: proportion of participants
0.074
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Testing With ELISA Rapid Testing
Hide Arm/Group Description

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).

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.

All-Cause Mortality
Standard Testing With ELISA Rapid Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Testing With ELISA Rapid Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)   0/162 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Testing With ELISA Rapid Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)   0/162 (0.00%) 
Single-center pilot study, possibly reducing generalizability; small number of participants and infected individuals may have decreased power to detect differences in linkage-to-care; not all rapid tests were approved for routine use in France.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julie Bottero
Organization: Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine
Phone: +33 1 49 28 04 24
EMail: julie.bottero@aphp.fr
Layout table for additonal information
Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01790633     History of Changes
Other Study ID Numbers: IMEA 38B
2012-A01681-42 ( Other Identifier: ANSM )
First Submitted: February 7, 2013
First Posted: February 13, 2013
Results First Submitted: August 25, 2016
Results First Posted: December 13, 2016
Last Update Posted: December 13, 2016