Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia
- Conditions
- Hepatitis C, Chronic
- Interventions
- Other: HCV viremia testing approaches
- Registration Number
- NCT03594838
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1672
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Centralized testing approach HCV viremia testing approaches 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. Decentralized testing approach HCV viremia testing approaches 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.
- Primary Outcome Measures
Name Time Method HCV confirmatory viremia test result receipt 1-30 days 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)
HCV care cascade 6 months 1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade
- Secondary Outcome Measures
Name Time Method Uptake of HCV confirmatory viremia testing 4-8 weeks Facilitators and barriers of getting an HCV confirmatory viremia test as perceived by participants and health care workers
Cost of HCV confirmatory viremia testing approach 6 months Costs of HCV viremia testing approaches from a health service and patient perspective
Entry into HCV care 1-14 days 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)
HCV confirmatory viremia test result receipt by intervention 1-14 day 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
Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale 4-8 weeks 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)
Operational performance of HCV confirmatory viremia testing 6 months Testing volumes at the harm reduction sites
Treatment Initiation Fraction 4 weeks Proportion of participants with positive HCV viremia test who initiate hepatitis treatment
Trial Locations
- Locations (6)
Imedi Harm Reduction Site
🇬🇪Batumi, Georgia
Step to the Future Harm Reduction Site
🇬🇪Gori, Georgia
New Way Harm Reduction Site
🇬🇪Tbilisi, Georgia
Akeso Harm Reduction Site
🇬🇪Tbilisi, Georgia
Xenon Harm Reduction Site
🇬🇪Zugdidi, Georgia
New Vector Harm Reduction Site
🇬🇪Tbilisi, Georgia