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Clinical Trials/NCT04177043
NCT04177043
Completed
Phase 4

Educate, Test and Treat Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages

Egyptian Liver Hospital0 sites221,855 target enrollmentJune 2015

Overview

Phase
Phase 4
Intervention
HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
Conditions
Hepatitis C, Chronic
Sponsor
Egyptian Liver Hospital
Enrollment
221855
Primary Endpoint
incidince of HCV in population
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Background: The global response to the HCV infection epidemic has been transformed by the availability of low-cost curative short course direct acting antiviral (DAA) therapy. Egypt has one of the highest burdens of HCV infection worldwide, and a large treatment programme, but reaching rural communities represents a major challenge. We report the feasibility and effectiveness of a comprehensive community-based HCV prevention, testing and treatment model in 73 villages across Egypt, with the goal to eliminate infection from all adult villagers.

Methods: An HCV "educate, test and treat" programme was implemented in 73 villages across 7 governorates in Egypt between 06/2015 and 06/2018. The programme model comprised community mobilization facilitated by a network of village promoters to support the education, test and treat campaign as well as fund raising in the local community; a comprehensive testing, linkage to care and treatment of all eligible villagers aged 12 to 80 years using HCV antibody and HBsAg rapid diagnostic tests (RDTs), HCV RNA confirmation of positive cases, staging of liver disease using transient elastography (FibroScan), treatment with 12 or 24 weeks of a direct acting antiviral (DAA) regimen according to national standard of HCV care, and an assessment of cure at 12 weeks after completion of treatment (SVR12); and an education campaign to raise awareness and disseminate messages about safer practices to reduce transmission through public events, promotional materials and house-to-house visits. Key outcomes assessed in each village were: uptake of serological HCV and HBV testing, linkage to assessment and HCV viral load confirmation, uptake of treatment, and SVR12.

Detailed Description

Background: The global response to the HCV infection epidemic has been transformed by the availability of low-cost curative short course direct acting antiviral (DAA) therapy. Egypt has one of the highest burdens of HCV infection worldwide, and a large treatment programme, but reaching rural communities represents a major challenge. We report the feasibility and effectiveness of a comprehensive community-based HCV prevention, testing and treatment model in 73 villages across Egypt, with the goal to eliminate infection from all adult villagers. Methods: An HCV "educate, test and treat" programme was implemented in 73 villages across 7 governorates in Egypt between 06/2015 and 06/2018. The programme model comprised community mobilization facilitated by a network of village promoters to support the education, test and treat campaign as well as fund raising in the local community; a comprehensive testing, linkage to care and treatment of all eligible villagers aged 12 to 80 years using HCV antibody and HBsAg rapid diagnostic tests (RDTs), HCV RNA confirmation of positive cases, staging of liver disease using transient elastography (FibroScan), treatment with 12 or 24 weeks of a direct acting antiviral (DAA) regimen according to national standard of HCV care, and an assessment of cure at 12 weeks after completion of treatment (SVR12); and an education campaign to raise awareness and disseminate messages about safer practices to reduce transmission through public events, promotional materials and house-to-house visits. Key outcomes assessed in each village were: uptake of serological HCV and HBV testing, linkage to assessment and HCV viral load confirmation, uptake of treatment, and SVR12.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Egyptian Liver Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • persons aged between 12 to 80 years across the 73 villages eligible for inclusion in the test and treat program.

Exclusion Criteria

  • aged below 12

Arms & Interventions

Screening

Intervention: HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests

Screening

Intervention: DAAs

Outcomes

Primary Outcomes

incidince of HCV in population

Time Frame: 3 years

incidence of HCV hidden population confirmed by Rt-PCR

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