NCT03896087

Brief Summary

FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
942

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

March 14, 2019

Last Update Submit

December 16, 2020

Conditions

Hepatitis C, Chronic

Keywords

dried blood spotsplasma separation cardHCV RNA test

Outcome Measures

Primary Outcomes (2)

  • Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site

    Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site

    day 1 - day 30

  • Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site

    Evaluation of the correlation of HCV viral load level determined by each assay performed

    day 1 - day 30

Secondary Outcomes (5)

  • Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma

    day 1 - day 30

  • Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay

    day 1 - day 30

  • WHO technician's appraisal sheet completed by all operators performing investigational test

    through study completion, an average of 1 year

  • point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection in plasma measured against the performance of Roche cobas® 6800 HCV VL assay

    day 7 - day 30

  • evaluation of the correlation of HCV RNA levels in plasma determined by each assay with HCV RNA levels in plasma determined by Roche cobas® 6800 HCV VL assay

    day 7 - day 30

Study Arms (2)

clinical performance of the HCV DBS assay

EXPERIMENTAL

The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA.

Diagnostic Test: Abbott RealTime HCV assay from DBSDiagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBSDiagnostic Test: Aptima® HCV Quant Dx Assay from DBSDiagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS

comparison PQ marked reference assay arm

ACTIVE COMPARATOR

Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.

Diagnostic Test: Abbott RealTime HCV assay from DBSDiagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBSDiagnostic Test: Aptima® HCV Quant Dx Assay from DBSDiagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS

Interventions

Abbott RealTime HCV assay from DBSDIAGNOSTIC_TEST

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.

clinical performance of the HCV DBS assaycomparison PQ marked reference assay arm
HCV for use on the cobas® 6800/8800 Systems from PSC and DBSDIAGNOSTIC_TEST

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.

clinical performance of the HCV DBS assaycomparison PQ marked reference assay arm
Aptima® HCV Quant Dx Assay from DBSDIAGNOSTIC_TEST

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.

clinical performance of the HCV DBS assaycomparison PQ marked reference assay arm
HCV for use on the cobas® 4800Systems from PSC and DBSDIAGNOSTIC_TEST

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.

clinical performance of the HCV DBS assaycomparison PQ marked reference assay arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Able to understand the scope of the trial
  • Provided written informed consent
  • Documented positive result of HCV serology test
  • Individuals at risk of having HCV infection based on past and/or current exposure to risk factors
  • Aged 18 years or older
  • Able to understand the scope of the trial
  • Provided written informed consent
  • Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I)
  • Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response)
  • Aged 18 years or older
  • Able to understand the scope of the trial
  • Provided written informed consent
  • Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial

You may not qualify if:

  • Previously enrolled in the trial
  • Unwilling to provide required volume of fingerstick blood
  • Unwilling to provide required volume of venous whole blood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St Vincent's Institute of Medical Research National Serology Reference Laboratory

Victoria Park, Fitzroy, 3065, Australia

Location

Centre Pasteur du Cameroun

Yaoundé, Yaounde, Cameroon

Location

National Centre for Disease Control

Tbilisi, Georgia

Location

Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases

Athens, 11527, Greece

Location

Rwanda Military Hospital

Kigali, Kanombe, 0000, Rwanda

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elena Ivanova, Ph.D.

    Foundation for Innovative New Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 29, 2019

Study Start

April 1, 2019

Primary Completion

November 30, 2020

Study Completion

December 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)GR(1)RW(1)GE(1)CA(1)