Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

NCT03594838 | Completed

• 1 other identifier: 8157-3/1
• Study Type: interventional
• Target: 1,672
• Locations: 1 country
• Sites: 8

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.

Conditions

Hepatitis C, Chronic

Keywords

HCV viremia testing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Entry into HCV care

  1-14 days

• Treatment Initiation Fraction

  4 weeks

• HCV confirmatory viremia test result receipt by intervention

  1-14 day

• Cost of HCV confirmatory viremia testing approach

  6 months

• Operational performance of HCV confirmatory viremia testing

  6 months

Study Arms (3)

Decentralized testing approach

EXPERIMENTAL

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

Centralized testing approach

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

HCV viremia testing approaches OTHER

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)

Centralized testing approach; Decentralized testing approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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:
• Perform HCV viremia testing

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• The National Center for Disease Control and Public Health: collaborator
• Health Research Union: collaborator

Study Sites (8)

Imedi Harm Reduction Site

Batumi, Georgia

Location

Step to the Future Harm Reduction Site

Gori, Georgia

Location

New Way Harm Reduction Site

Kutaisi, Georgia

Location

New Vector Harm Reduction Site

Rustavi, Georgia

Location

Akeso Harm Reduction Site

Tbilisi, Georgia

Location

New Vector Harm Reduction Site

Tbilisi, Georgia

Location

New Way Harm Reduction Site

Tbilisi, Georgia

Location

Xenon Harm Reduction Site

Zugdidi, Georgia

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sonjelle Shilton

  Find

  STUDY DIRECTOR

• Irma Khonelidze

  National Centre for Disease Control, Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 20, 2018
• Study Start: May 21, 2018
• Primary Completion: September 30, 2019
• Study Completion: July 21, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

GE (8)