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COMPLETED
NCT04961723
NA

HCV Self-testing in Georgia

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

View on ClinicalTrials.gov

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.

Official title: Randomized Control Trial of Home-based Hepatitis C Self-testing in Key Populations in Georgia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1250

Start Date

2021-12-10

Completion Date

2022-08-30

Last Updated

2026-09-16

Healthy Volunteers

Yes

Interventions

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.

Locations (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