Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
DAAs
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis C, Chronic
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Screening
Arm Description
Outcomes
Primary Outcome Measures
incidince of HCV in population
incidence of HCV hidden population confirmed by Rt-PCR
Secondary Outcome Measures
Full Information
NCT ID
NCT04177043
First Posted
February 20, 2019
Last Updated
November 22, 2019
Sponsor
Egyptian Liver Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04177043
Brief Title
Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages
Official Title
Educate, Test and Treat Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egyptian Liver Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221855 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
Intervention Description
HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
Intervention Type
Drug
Intervention Name(s)
DAAs
Intervention Description
Treatment with different regiments with DAAs
Primary Outcome Measure Information:
Title
incidince of HCV in population
Description
incidence of HCV hidden population confirmed by Rt-PCR
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages
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