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Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

NCT03594838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1672

Last updated 2020-07-22

No results posted yet for this study

Summary

This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. These approaches will be compared to the current standard of care (control) in which anti-HCV-positive individuals must travel to a HCV treatment centre for HCV viremia testing. The investigators hypothesize that improving access to viremia testing improves linkage to care and reduces loss to follow-up among those who screen anti-HCV-positive.

Conditions

  • Hepatitis C, Chronic

Interventions

OTHER

HCV viremia testing approaches

Blood draw and HCV viremia testing is done at point of service (Intervention A) Blood draw at point of service and HCV viremia testing at a centralized laboratory (Intervention B)

Sponsors & Collaborators

  • The National Center for Disease Control and Public Health

    collaborator UNKNOWN

  • Health Research Union

    collaborator UNKNOWN

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Sonjelle Shilton · Find

  • Irma Khonelidze · National Centre for Disease Control, Georgia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2019-09-30
Completion
2020-07-21

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594838 on ClinicalTrials.gov