Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia (HEAD-Start)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Other: HCV viremia testing approaches

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 Type: Interventional
• Enrollment (Actual): 1672
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Batumi, Georgia
    • Imedi Harm Reduction Site
  • Gori, Georgia
    • Step to the Future Harm Reduction Site
  • Kutaisi, Georgia
    • New Way Harm Reduction Site
  • Rust'avi, Georgia
    • New Vector Harm Reduction Site
  • Tbilisi, Georgia
    • Akeso Harm Reduction Site
  • Tbilisi, Georgia
    • New Vector Harm Reduction Site
  • Tbilisi, Georgia
    • New Way Harm Reduction Site
  • Zugdidi, Georgia
    • Xenon Harm Reduction Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decentralized testing approach; 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.	Other: HCV 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)
Experimental: Centralized testing approach; 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.	Other: HCV 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)
No Intervention: Standard of Care; Current standard of care. Patients who screen anti-HCV positive at HRS will be referred to HCV treatment centers for HCV RNA testing, and results will be provided at a follow-up visit to the treatment center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV care cascade	1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade	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)	1-30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1-14 days
Treatment Initiation Fraction	Proportion of participants with positive HCV viremia test who initiate hepatitis treatment	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	1-14 day
Cost of HCV confirmatory viremia testing approach	Costs of HCV viremia testing approaches from a health service and patient perspective	6 months
Operational performance of HCV confirmatory viremia testing	Testing volumes at the harm reduction sites	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	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)	4-8 weeks

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: The National Center for Disease Control and Public Health; Health Research Union
• Investigators: Study Director: Sonjelle Shilton, Find; Principal Investigator: Irma Khonelidze, National Centre for Disease Control, Georgia

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HCV viremia testing
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Sepsis; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Viremia
• Other Study ID Numbers: 8157-3/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No