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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,672
- Locations
- 8
- Primary Endpoint
- HCV confirmatory viremia test result receipt
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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)