942
Participants
Start Date
April 1, 2019
Primary Completion Date
November 30, 2020
Study Completion Date
December 1, 2020
Abbott RealTime HCV assay from DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Aptima® HCV Quant Dx Assay from DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
HCV for use on the cobas® 4800Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
St Vincent's Institute of Medical Research National Serology Reference Laboratory, Victoria Park
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases, Athens
Centre Pasteur du Cameroun, Yaoundé
National Centre for Disease Control, Tbilisi
Rwanda Military Hospital, Kigali
UNITAID
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER