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NCT04136405 Clinical Trial

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

Chronic Hepatitis c Clinical Trial

— REVERSO  

Official title:
Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04136405
Other study ID # ANRS 12389 REVERSO
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 14, 2020
Est. completion date August 2021

Study information
Verified date April 2021
Source ANRS, Emerging Infectious Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

Description:

A previous ANRS (French National Agency for Research on AIDS and Viral Hepatitis)12270 study supported by Burkina Faso's Minister of Health, used blood samples from the 2010 Demographic and Health Survey (DHS) to document the country's national and regional prevalences and highlighted a localized HCV epidemic in the Southwest Region with a prevalence of 13.2% which was 4 times higher than the national prevalence. This high prevalence of HCV was found in both adults and youth. Given the particular epidemiological situation of the South-West region and the limits of the 2010 DHS, we aimed to carry out a thorough investigation of this HCV epidemic in the South-West region of Burkina Faso in order to control it. A mixed methodology (quantitative and qualitative) will be used including: (i) a cross-sectional survey to estimate the prevalence of HCV infection in the South-West population in Burkina Faso; (ii) a case-control study among individuals less than 20 years of age to identify factors associated with current HCV transmission; (iii) a qualitative survey to provide additional information explaining the high prevalence of HCV infection (historical events, for example); (iv) a cohort study to evaluate a pilot treatment management strategy to be implemented by the national program in the South West Region

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3300
Est. completion date August 2021
Est. primary completion date August 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - To be a usual resident of the Burkina Faso South West region - Express informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Burkina Faso Région du Sud-Ouest Gaoua

Sponsors (3)
Lead Sponsor Collaborator
ANRS, Emerging Infectious Diseases Centre Muraz, Université Montpellier

Country where clinical trial is conducted

Burkina Faso, 

Outcome
Type Measure Description Time frame Safety issue
Primary HCV seroprevalence proportion of individuals with a past or present HCV infection (rapid test) at inclusion (cross-sectional survey)
Secondary Chronic hepatitis C prevalence proportion of individuals with chronic hepatitis (plasma HCV viral load by PCR) at inclusion (cross-sectional survey)
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