Hepatitis C, Chronic
Conditions
Keywords
HCV viremia testing
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.
Interventions
OTHERHCV viremia testing approaches
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)
Sponsors
The National Center for Disease Control and Public Health
Health Research Union
Foundation for Innovative New Diagnostics, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. HRS staff involved in HCV testing and care: Inclusion criteria * Provide HCV services at HRS from screening through linkage to care. 3. Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres: Inclusion criteria: * Perform HCV viremia testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
Countries
Georgia
Outcome results
None listed