Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2020-07-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A non-randomized 3 arm-interventional study at eight HRSs to evaluate two novel approaches of HCV viremia testing and compare them to the current standard of care. The HRS will be assigned to one of three study arms.

Six HRSs will provide HCV viremia testing on-site using one of two approaches as follows and two HRS will refer patients off-site for testing (current standard of care).

The three arms will be compared to determine differences in the proportion of anti-HCV-positive patients that receive HCV viremia test results.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Decentralized testing approach

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.

Group Type EXPERIMENTAL

HCV viremia testing approaches

Intervention Type OTHER

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)

Centralized testing approach

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.

Group Type EXPERIMENTAL

HCV viremia testing approaches

Intervention Type OTHER

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)

Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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

* 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:

* Perform HCV viremia testing

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:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No