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

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ClinicalTrials.gov Identifier: NCT03594838
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
The National Center for Disease Control and Public Health
Health Research Union
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Other: HCV viremia testing approaches Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1860 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : August 21, 2019
Estimated Study Completion Date : October 21, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594838


Contacts
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Contact: Violet Chihota +41227109313 violet.chihota@finddx.org
Contact: Sonjelle Shilton +41227100959 Sonjelle.Shilton@finddx.org

Locations
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Georgia
Imedi Harm Reduction Site Recruiting
Batumi, Georgia
Step to the Future Harm Reduction Site Recruiting
Gori, Georgia
New Way Harm Reduction Site Recruiting
Kutaisi, Georgia
New Vector Harm Reduction Site Recruiting
Rust'avi, Georgia
Akeso Harm Reduction Site Recruiting
Tbilisi, Georgia
New Vector Harm Reduction Site Recruiting
Tbilisi, Georgia
New Way Harm Reduction Site Recruiting
Tbilisi, Georgia
Xenon Harm Reduction Site Recruiting
Zugdidi, Georgia
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
The National Center for Disease Control and Public Health
Health Research Union
Investigators
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Study Director: Francesco Marinucci Find
Principal Investigator: Irma Khonelidze National Centre for Disease Control, Georgia

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03594838     History of Changes
Other Study ID Numbers: 8157-3/1
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
HCV viremia testing

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Viremia
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes