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

April 16, 2021 updated by: ANRS, Emerging Infectious Diseases
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.

Study Overview

Status

Active, not recruiting

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

3300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

General population of South West region of Burkina Faso

Description

Inclusion Criteria:

  • To be a usual resident of the Burkina Faso South West region
  • Express informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV seroprevalence
Time Frame: at inclusion (cross-sectional survey)
proportion of individuals with a past or present HCV infection (rapid test)
at inclusion (cross-sectional survey)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic hepatitis C prevalence
Time Frame: at inclusion (cross-sectional survey)
proportion of individuals with chronic hepatitis (plasma HCV viral load by PCR)
at inclusion (cross-sectional survey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

August 4, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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