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COMPLETED
NCT04971538
NA

HCV Self-testing in Pakistan

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

View on ClinicalTrials.gov

Summary

To achieve the goal of elimination of hepatitis C infection in Pakistan, the strategy of elimination needs to be increasingly directed towards case finding through mass screening in rural or peri-urban communities to identify and treat those not yet aware of their infection. Self-testing (ST) 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. In the present study we aim to evaluate the acceptability and impact of a program enabling home delivery of hepatitis C virus (HCV) self-testing in the Malir district, Karachi division, Pakistan.

Official title: Cluster Randomized Controlled Study of Home-based Hepatitis C Self-testing in Karachi, Pakistan

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2021-11-29

Completion Date

2023-06-08

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 (1)

Aga Khan University

Karachi, Sindh, Pakistan