MedTrace Logo

HCV Self-testing in Georgia

NCT04961723 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2022-02-28

No results posted yet for this study

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.

Conditions

  • Hepatitis C
  • Diagnostic Self Evaluation

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.

Sponsors & Collaborators

  • National Center for Disease control and Public Health

    collaborator OTHER_GOV

  • Batumi Imedi Harm Reduction Site

    collaborator UNKNOWN

  • Equality Movement

    collaborator UNKNOWN

  • Center for Information and Counseling on Reproductive Health - Tanadgoma

    collaborator OTHER

  • Tbilisi New Way Harm Reduction Site

    collaborator UNKNOWN

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Ketevan Stvilia · National Center for Disease Control and Public Health, Georgia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-06-30
Completion
2022-08-31

Countries

  • Georgia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961723 on ClinicalTrials.gov