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HCV Self-testing in Georgia

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ClinicalTrials.gov Identifier: NCT04961723
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : February 28, 2022
Sponsor:
Collaborators:
National Center for Disease control and Public Health
Batumi Imedi Harm Reduction Site
Equality Movement
Center for Information and Counseling on Reproductive Health - Tanadgoma
Tbilisi New Way Harm Reduction Site
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:
Self-testing with easy-to-use rapid diagnostic tests has been successfully used for diseases such as HIV. The availability of self-testing has been shown to increase testing rates and testing acceptability in diverse populations around the world, in large part due to its convenience and privacy advantages.7 Self-testing has also been effectively used to reach key populations who may not be covered by traditional healthcare programs, such as persons who inject drugs (PWID) and men who have sex with men (MSM). In Georgia, HIV self-testing has been offered to MSM through an online platform promoting their uptake.11-12 In the present study aims to evaluate the acceptability and impact of using an online platform to enable home delivery of HCV self-testing in Georgia for PWID and MSM.

Condition or disease Intervention/treatment Phase
Hepatitis C Diagnostic Self Evaluation Diagnostic Test: (OraQuick® HCV Self-Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

5 arm randomized control trial evaluating models of care by population group. For MSM group 3 arms; a postal delivery model of HCV antibody self-test, a peer delivery model of HCV antibody self-test compared the standard or care (participant going to clinic for HCV antibody RDT).

For PWID 2 arms; a peer delivery model of HCV antibody self-test compared the standard or care (participant going to clinic for HCV antibody RDT).

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Control Trial of Home-based Hepatitis C Self-testing in Key Populations in Georgia
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MSM Postal delivery
Participants who identify primarily as MSM will receive a home delivered HCV self-test kit in non-identifiable packaging. The kit will include the test, instructions for use (IFU), and information about additional supporting materials, such as access to live chat and a call center for questions about testing
Diagnostic Test: (OraQuick® HCV Self-Test
The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.

Experimental: MSM Peer delivery
Participants who identify primarily as MSM will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing
Diagnostic Test: (OraQuick® HCV Self-Test
The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.

No Intervention: MSM control
Participants who identify primarily as MSM will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing
Experimental: PWID peer delivery
Participants who identify primarily as PWID will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing
Diagnostic Test: (OraQuick® HCV Self-Test
The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.

No Intervention: PWID control
Participants who identify primarily as PWID will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing



Primary Outcome Measures :
  1. To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM [ Time Frame: 2 weeks to 2 months after enrollment ]
    The number of participants who report completing the HCV antibody testing in the intervention group vs the control group

  2. To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM [ Time Frame: 2 weeks to 2 months after enrollment ]
    To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.


Secondary Outcome Measures :
  1. To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status [ Time Frame: 2 weeks to 2 months after enrollment ]
    Number of HCV antibody positive participants made aware of their status in the intervention vs control group

  2. To assess the impact of HCV self-testing on linkage and completion of HCV RNA confirmatory testing in HCV antibody positive individuals [ Time Frame: 2 weeks to end of study ]
    2.2 The number of HCV antibody positive participants who are referred to and complete HCV RNA confirmatory testing in the intervention vs control group

  3. To assess the impact of HCV self-testing on treatment initiation in HCV RNA positive individuals eligible to start treatment [ Time Frame: 2 weeks to end of study ]
    2.3 The number of HCV RNA positive participants who start treatment in the intervention vs control group

  4. To assess the acceptability of HCV self-testing at baseline and after study participation. [ Time Frame: 2 weeks to 3 months after enrollment ]
    2.4 Analysis of survey responses using proportions and means. The responses to the questionnaire at baseline and after study participation will be compared to assess if there are changes in acceptability of HCV self-testing

  5. To assess the cost of HCV self-testing [ Time Frame: entire duration of study, estimated 6 months ]
    Cost per test completed, cost per person diagnosed (serology, RNA) in the intervention vs control groups. The costs of each step on the testing pathway will be combined to determine the overall cost per person diagnosed with HCV viremia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   for MSM arms participant eligibility is based on if a person self-identifies as a men who has sex with men
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Able and eligible to access services on selftest.ge
  • Self-identify as a PWID and or MSM
  • Living in Batumi or Tbilisi
  • Able to understand the scope of the study and provide informed consent through online platform.
  • Able to read and understand Georgian
  • Unknown HCV serology status (i.e., never tested for HCV or tested HCV ab- in a most recent test performed no later than 6 months before enrolment)

Exclusion Criteria:

  • Self-reported previously confirmed positive HCV status (either Ab or RNA)
  • Un-eligible for Georgian National Hepatitis Elimination program

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): NCT04961723


Contacts
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Contact: Sonjelle Shilton +41 (22) 710 05 90 Sonjelle.Shilton@finddx.org

Locations
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Georgia
Center for Information and Counselling on Reproductive Health-Tanadgoma Recruiting
Batumi, Georgia
Contact: Nino Tsereteli         
Equality Movement Recruiting
Batumi, Georgia
Contact: Shota Pevadze         
Imedi Harm Reduction Site Recruiting
Batumi, Georgia
Contact: Miranda Jgenti         
Center for Information and Counselling on Reproductive Health-Tanadgoma Recruiting
Tbilisi, Georgia
Contact: Nino Tsereteli         
Equality Movement Recruiting
Tbilisi, Georgia
Contact: Shota Pevadze         
Tbilisi New Way Harm Reduction Site Recruiting
Tbilisi, Georgia
Contact: Dali Usharidze         
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
National Center for Disease control and Public Health
Batumi Imedi Harm Reduction Site
Equality Movement
Center for Information and Counseling on Reproductive Health - Tanadgoma
Tbilisi New Way Harm Reduction Site
Investigators
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Principal Investigator: Ketevan Stvilia National Center for Disease Control and Public Health, Georgia
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT04961723    
Other Study ID Numbers: HC022
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
People who inject drugs (PWID)
Men who have sex with men (MSM)
Linkage to care
Online self-test distribution
self-test
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections