Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

Hepatitis C, Chronic Clinical Trial

— HEAD-Start  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594838
• Other study ID #: 8157-3/1
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: July 21, 2020

Study information

• Verified date: July 2020
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1672
• Est. completion date: July 21, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic
• Viremia

Intervention

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)

Locations

Country	Name	City	State
Georgia	Imedi Harm Reduction Site	Batumi
Georgia	Step to the Future Harm Reduction Site	Gori
Georgia	New Way Harm Reduction Site	Kutaisi
Georgia	New Vector Harm Reduction Site	Rust'avi
Georgia	Akeso Harm Reduction Site	Tbilisi
Georgia	New Vector Harm Reduction Site	Tbilisi
Georgia	New Way Harm Reduction Site	Tbilisi
Georgia	Xenon Harm Reduction Site	Zugdidi

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Health Research Union, The National Center for Disease Control and Public Health

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Treatment Initiation Fraction	Proportion of participants with positive HCV viremia test who initiate hepatitis treatment	4 weeks
Secondary	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
Secondary	Cost of HCV confirmatory viremia testing approach	Costs of HCV viremia testing approaches from a health service and patient perspective	6 months
Secondary	Operational performance of HCV confirmatory viremia testing	Testing volumes at the harm reduction sites	6 months
Secondary	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
Secondary	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