Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177043
• Other study ID #: village2015
• Status: Completed
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2019
• Source: Egyptian Liver Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221855
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Diagnostic Test:
• HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests

Drug:
• DAAs
Treatment with different regiments with DAAs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Liver Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidince of HCV in population	incidence of HCV hidden population confirmed by Rt-PCR	3 years