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Completed

NCT Number: NCT03594838

Evaluation of HCV Viremia Testing Approaches Among PWID 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imedi Harm Reduction Site, Batumi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • HRS staff involved in HCV testing and care:

Inclusion criteria

  • 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:

Inclusion criteria

  • Perform HCV viremia testing

Treatment and study plan

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)

Primary outcomes

  1. HCV care cascade

    Time frame: 6 months

    1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade

  2. HCV confirmatory viremia test result receipt

    Time frame: 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 outcomes

  1. Entry into HCV care

    Time frame: 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)

  2. Treatment Initiation Fraction

    Time frame: 4 weeks

    Proportion of participants with positive HCV viremia test who initiate hepatitis treatment

  3. HCV confirmatory viremia test result receipt by intervention

    Time frame: 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

  4. Cost of HCV confirmatory viremia testing approach

    Time frame: 6 months

    Costs of HCV viremia testing approaches from a health service and patient perspective

  5. Operational performance of HCV confirmatory viremia testing

    Time frame: 6 months

    Testing volumes at the harm reduction sites

  6. Uptake of HCV confirmatory viremia testing

    Time frame: 4-8 weeks

    Facilitators and barriers of getting an HCV confirmatory viremia test as perceived by participants and health care workers

  7. Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • Health Research Union
  • National Center for Disease control and Public Health

Registry information

Official study 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

Acronym: HEAD-Start

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 20, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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