Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

Study Overview
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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.

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.

Official Title
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Feasibility, Acceptability, Effectiveness and Cost-analysis of Models of HCV Viremia Testing for Confirmation and Cure Among People Who Inject Drugs (PWID): the HEAD*-Start Trial in Georgia

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Other: HCV viremia testing approaches


Participation Criteria
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Eligibility Criteria
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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 HRS staff involved in HCV testing and care: Inclusion criteria Provide HCV services at HRS from screening through linkage to care. Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres: Inclusion criteria: Perform HCV viremia testing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decentralized testing approach<br>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. | Other: HCV viremia testing approaches<br>* 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)<br>|
| Experimental: Centralized testing approach<br>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. | Other: HCV viremia testing approaches<br>* 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)<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV care cascade | 1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade | 6 months | 
| HCV confirmatory viremia test result receipt | Proven superiority (with a margin of 10%) of the proportion of participants with a positive anti-HCV test who receive results of an HCV confirmation of viremia test in each intervention arm separately, compared to referral-based testing (SOC) | 1-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Entry into HCV care | Proven superiority (with a margin of 10%) of the proportion of participants with positive anti-HCV test who submit a blood sample for viremia testing in each intervention arm separately, compared to referral based testing (SOC) | 1-14 days | 
| Treatment Initiation Fraction | Proportion of participants with positive HCV viremia test who initiate hepatitis treatment | 4 weeks | 
| HCV confirmatory viremia test result receipt by intervention | Proportion of participants with a positive anti-HCV test who receive results of an HCV confirmation of viremia test using decentralized HCV RNA testing compared to centralized HCV core antigen | 1-14 day | 
| Cost of HCV confirmatory viremia testing approach | Costs of HCV viremia testing approaches from a health service and patient perspective | 6 months | 
| Operational performance of HCV confirmatory viremia testing | Testing volumes at the harm reduction sites | 6 months | 
| Uptake of HCV confirmatory viremia testing | Facilitators and barriers of getting an HCV confirmatory viremia test as perceived by participants and health care workers | 4-8 weeks | 
| Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale | Willingness of participants to get HCV confirmatory viremia testing as assessed on the Likert Scale of 'strongly agree' (0), 'agree' (1), 'neither agree nor disagree' (2), 'disagree' (3), 'strongly disagree' (4) | 4-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV viremia testing