This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01790633
First received: February 7, 2013
Last updated: October 19, 2016
Last verified: October 2016
Results First Received: August 25, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Standard Testing With ELISA   Rapid Testing
STARTED   163   164 
COMPLETED   115   159 
NOT COMPLETED   48   5 
Protocol Violation                1                2 
Did not have serology performed                47                0 
RT failure and no follow-up ELISA                0                3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Standard Testing With ELISA   Rapid Testing   Total 
Overall Participants Analyzed 
[Units: Participants]
 162   162   324 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (12.2)   37.0  (12.2)   37.6  (12.1) 
Gender 
[Units: Participants]
     
Female   60   63   123 
Male   102   99   201 
HBV prevalence of birth country 
[Units: 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 
[Units: Participants]
 162   162   324 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Accessibility of Testing Results   [ Time Frame: Evaluated once, up to 4 months after testing ]

2.  Secondary:   Access to Care   [ Time Frame: Evaluated once, up to 4 months after testing ]

3.  Other Pre-specified:   Proportion Participating   [ Time Frame: At testing ]

4.  Other Pre-specified:   Proportion of Rapid Test Failures   [ Time Frame: At testing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

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:  
Name/Title: Dr. Julie Bottero
Organization: Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine
phone: +33 1 49 28 04 24
e-mail: julie.bottero@aphp.fr


Publications of Results:
Other Publications:

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 )
Study First Received: February 7, 2013
Results First Received: August 25, 2016
Last Updated: October 19, 2016