Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia (HEAD-Start)

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Other: HCV viremia testing approaches

Study type: Interventional

Funder types: Other

Identifiers

NCT03594838

8157-3/1

Details and patient eligibility

About

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.

Full description

A major step in identifying HCV infected individuals in Georgia has already been implemented by providing rapid anti-HCV testing for people who inject drugs (PWID) at HRS. However, access to HCV confirmatory viremia testing remains limited as PWID must be referred to treatment centers for testing.

Two novel approaches to improve access to HCV viremia testing will be evaluated.

In the first approach, participants with a positive anti-HCV test will have blood drawn and HCV RNA test performed at the HRS. Test results will be provided the same day (or the following day if the participant is unable to wait for results) at the HRS.

In the second approach participants with a positive anti-HCV test will have blood drawn at the HRS. The blood will be processed on site and a plasma sample shipped to a central laboratory for viremia testing. Test results will be communicated to the participants by HRS staff at a follow-up visit as soon as the results are available.

In both groups, participants who test positive will be referred to a treatment centre for further assessments and subsequent treatment initiation.

Enrollment: 1,672 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. People who inject drugs attending for care and needle provision at harm reduction sites.

   Inclusion criteria:

   • Any history of injection drug use (IDU)
   • Age ≥18 years
   • Anti-HCV-positive on rapid diagnostic test performed at the HRS
   • Eligible for the Georgia HCV State Program
   • Living in the catchment area served by the HRS
   • No plans to move out of the catchment area during the next 6 months
   • Willing and able to give informed consent

   Exclusion criteria:

   • Tested HCV RNA-positive from April 2015
   • Pregnancy (self-report)
   • Currently on treatment for hepatitis C
   • Unable to provide a blood sample

2. HRS staff involved in HCV testing and care:

   Inclusion criteria

   • Provide HCV services at HRS from screening through linkage to care.

3. Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres:

Inclusion criteria:

• Perform HCV viremia testing

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,672 participants in 3 patient groups

Decentralized testing approach

Experimental group

Description:

Harm reduction site HCV viremia testing approach A. Four HRS will conduct blood draw and point-of-service (decentralized) HCV RNA testing, and results will be provided at the HRS on the same or the following day.

Treatment:

Other: HCV viremia testing approaches

Centralized testing approach

Experimental group

Description:

Harm reduction site HCV viremia testing approach B. Two sites will collect blood samples on site and transport them to a reference (centralized) laboratory for HCV viremia testing. Results will be provided at a follow-up visit to the HRS as soon as results are available.

Treatment:

Other: HCV viremia testing approaches

Standard of Care

No Intervention group

Description:

Current standard of care. Patients who screen anti-HCV positive at HRS will be referred to HCV treatment centers for HCV RNA testing, and results will be provided at a follow-up visit to the treatment center.