NCT04139941

Brief Summary

This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
2 countries

2 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

Study Start

First participant enrolled

July 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

October 7, 2019

Last Update Submit

July 6, 2020

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of HCV RDTs compared to a composite reference standard

    1.1 Point estimates of sensitivity, specificity, positive and negative predicative values (with 95% confidence intervals) and Cohen's Kappa Coefficient (κ) of inter-rater agreement for each RDT, using a combination of two EIAs (Enzyme Immunoassay) and an LIA (Line immunoassay) as a composite reference standard for the detection of anti-HCV antibodies in fingerstick whole blood, EDTA plasma and serum.

    through study completion, on average 1 year

Secondary Outcomes (3)

  • Sensitivity and specificity of HCV RDTs compared to an HCV RDT pre-qualified by WHO as reference standard

    through study completion, on average 1 year

  • Operational characteristics

    through study completion, on average 1 year

  • Operational characteristics

    through study completion, on average 1 year

Study Arms (1)

Individuals with known or unknown HCV status

Diagnostic Test: Test for HCV antibodies with an RDT

Interventions

Test for HCV antibodies with an RDTDIAGNOSTIC_TEST

Fingerstick whole blood, plasma and serum of each participant is tested with three investigational HCV RDTs and one reference HCV RDT. Plasma is also used for testing with the composite reference standard, HCV viral load and genotyping. All participants are also tested for HIV with an HIV RDT.

Individuals with known or unknown HCV status

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* General population * HCV high-risk individuals

You may qualify if:

  • ≥ 18 years of age
  • Known or unknown HCV serology
  • No history of past or present HCV treatment
  • Willing to undergo the information and consenting procedure and subsequently have enough time to participate in the study
  • Willing to provide 13 ml venepuncture blood sample and a minimum of four whole blood fingerstick samples
  • Willing to perform an HIV test
  • Individuals can already be registered at the local site or register for the first time when enrolling in the study

You may not qualify if:

  • Participants not able to consent themselves (incapable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sihanouk Hospital Centre of Hope

Phnom Penh, Cambodia

Location

National Center for Disease Control & Public Health/Lugar Center

Tbilisi, 0198, Georgia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Left-over and unused back up samples of plasma and serum will be stored at a bio-repository

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 25, 2019

Study Start

July 31, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared with the manufacturers who's RDTs are being evaluated

Shared Documents
CSR
Time Frame
end of study

Locations

GE(1)CA(1)