HCV Self-testing in Georgia
Randomized Control Trial of Home-based Hepatitis C Self-testing in Key Populations in Georgia
1 other identifier
interventional
1,250
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
December 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 28, 2022
July 1, 2021
6 months
June 19, 2021
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM
The number of participants who report completing the HCV antibody testing in the intervention group vs the control group
2 weeks to 2 months after enrollment
To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM
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%.
2 weeks to 2 months after enrollment
Secondary Outcomes (5)
To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status
2 weeks to 2 months after enrollment
To assess the impact of HCV self-testing on linkage and completion of HCV RNA confirmatory testing in HCV antibody positive individuals
2 weeks to end of study
To assess the impact of HCV self-testing on treatment initiation in HCV RNA positive individuals eligible to start treatment
2 weeks to end of study
To assess the acceptability of HCV self-testing at baseline and after study participation.
2 weeks to 3 months after enrollment
To assess the cost of HCV self-testing
entire duration of study, estimated 6 months
Study Arms (5)
MSM Postal delivery
EXPERIMENTALParticipants 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
MSM Peer delivery
EXPERIMENTALParticipants 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
MSM control
NO INTERVENTIONParticipants 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
PWID peer delivery
EXPERIMENTALParticipants 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
PWID control
NO INTERVENTIONParticipants 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Self-reported previously confirmed positive HCV status (either Ab or RNA)
- Un-eligible for Georgian National Hepatitis Elimination program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Foundation for Innovative New Diagnostics, Switzerlandlead
- National Center for Disease control and Public Healthcollaborator
- Batumi Imedi Harm Reduction Sitecollaborator
- Equality Movementcollaborator
- Center for Information and Counseling on Reproductive Health - Tanadgomacollaborator
- Tbilisi New Way Harm Reduction Sitecollaborator
Study Sites (6)
Center for Information and Counselling on Reproductive Health-Tanadgoma
Batumi, Georgia
Equality Movement
Batumi, Georgia
Imedi Harm Reduction Site
Batumi, Georgia
Center for Information and Counselling on Reproductive Health-Tanadgoma
Tbilisi, Georgia
Equality Movement
Tbilisi, Georgia
Tbilisi New Way Harm Reduction Site
Tbilisi, Georgia
Related Publications (1)
Shilton S, Stvilia K, Japaridze M, Tsereteli N, Usharidze D, Phevadze S, Jghenti M, Mozalevskis A, Markby J, Luhmann N, Johnson C, Nabeta P, Ongarello S, Reipold EI, Gamkrelidze A. Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial. BMJ Open. 2022 Sep 8;12(9):e056243. doi: 10.1136/bmjopen-2021-056243.
PMID: 36691209DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ketevan Stvilia
National Center for Disease Control and Public Health, Georgia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2021
First Posted
July 14, 2021
Study Start
December 10, 2021
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
February 28, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share