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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Enrollment
- 1672
- Locations
- 6
- Primary Endpoint
- HCV confirmatory viremia test result receipt
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
HCV confirmatory viremia test result receipt
Time Frame: 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
Time Frame: 6 months
1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade
Secondary Outcomes
- Uptake of HCV confirmatory viremia testing(4-8 weeks)
- Cost of HCV confirmatory viremia testing approach(6 months)
- Entry into HCV care(1-14 days)
- HCV confirmatory viremia test result receipt by intervention(1-14 day)
- Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale(4-8 weeks)
- Operational performance of HCV confirmatory viremia testing(6 months)
- Treatment Initiation Fraction(4 weeks)