Clinical trial NCT03594838: Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C, Chronic
Keywords: HCV viremia testing
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: The National Center for Disease Control and Public Health
name: Health Research Union
First posted: 2018-07-20
Enrollment: 1672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: HCV care cascade
timeFrame: 6 months
measure: HCV confirmatory viremia test result receipt
timeFrame: 1-30 days
Secondary outcomes:
measure: Entry into HCV care
timeFrame: 1-14 days
measure: Treatment Initiation Fraction
timeFrame: 4 weeks
measure: HCV confirmatory viremia test result receipt by intervention
timeFrame: 1-14 day
measure: Cost of HCV confirmatory viremia testing approach
timeFrame: 6 months
measure: Operational performance of HCV confirmatory viremia testing
timeFrame: 6 months
measure: Uptake of HCV confirmatory viremia testing
timeFrame: 4-8 weeks
measure: Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: Batumi
country: Georgia
facility: Imedi Harm Reduction Site
city: Gori
country: Georgia
facility: Step to the Future Harm Reduction Site
city: Kutaisi
country: Georgia
facility: New Way Harm Reduction Site
city: Rust'avi
country: Georgia
facility: New Vector Harm Reduction Site
city: Tbilisi
country: Georgia
facility: Akeso Harm Reduction Site
city: Tbilisi
country: Georgia
facility: New Vector Harm Reduction Site
city: Tbilisi
country: Georgia
facility: New Way Harm Reduction Site
city: Zugdidi
country: Georgia
facility: Xenon Harm Reduction Site
Study officials:
affiliation: Find
name: Sonjelle Shilton
role: STUDY_DIRECTOR
affiliation: National Centre for Disease Control, Georgia
name: Irma Khonelidze
role: PRINCIPAL_INVESTIGATOR
References: