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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,672
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)
Imedi Harm Reduction Site
Batumi, Georgia
Step to the Future Harm Reduction Site
Gori, Georgia
New Way Harm Reduction Site
Kutaisi, Georgia
New Vector Harm Reduction Site
Rustavi, Georgia
Akeso Harm Reduction Site
Tbilisi, Georgia
New Vector Harm Reduction Site
Tbilisi, Georgia
New Way Harm Reduction Site
Tbilisi, Georgia
Xenon Harm Reduction Site
Zugdidi, Georgia
HCV care cascade
1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade
Time frame: 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)
Time frame: 1-30 days
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)
Time frame: 1-14 days
Treatment Initiation Fraction
Proportion of participants with positive HCV viremia test who initiate hepatitis treatment
Time frame: 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
Time frame: 1-14 day
Cost of HCV confirmatory viremia testing approach
Costs of HCV viremia testing approaches from a health service and patient perspective
Time frame: 6 months
Operational performance of HCV confirmatory viremia testing
Testing volumes at the harm reduction sites
Time frame: 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
Time frame: 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)
Time frame: 4-8 weeks
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