Hepatitis C Virus Infection, Past or PresentREVERSONCT04136405
Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso
An observational study of Hepatitis C Virus Infection, Past or Present and Chronic Hepatitis c, run by ANRS, Emerging Infectious Diseases at 1 site in Burkina Faso.
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… Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection, Past or Present, Chronic Hepatitis c
- How many people
- 3,300 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 14 Jul 2020to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General population of South West region of Burkina Faso
Who may be able to join
- To be a usual resident of the Burkina Faso South West region
- Express informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV seroprevalence
proportion of individuals with a past or present HCV infection (rapid test)
Measured: at inclusion (cross-sectional survey)
Secondary outcomes (1)
Chronic hepatitis C prevalence
proportion of individuals with chronic hepatitis (plasma HCV viral load by PCR)
Measured: at inclusion (cross-sectional survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start14 Jul 2020
- Primary completion4 Aug 2020
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus Infection, Past or PresentStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Centre Muraz, Université Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136405
- Sponsor's protocol ID
- ANRS 12389 REVERSO
- Acronym
- REVERSO
- Status last verified
- Apr 2021
- First submitted
- 21 Oct 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso
- ClinicalTrials.gov ID
- NCT04136405
- Acronym / sponsor ID
- REVERSO / ANRS 12389 REVERSO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Centre Muraz, Université Montpellier
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population of South West region of Burkina Faso
Key inclusion criteria (2 listed)
- To be a usual resident of the Burkina Faso South West region
- Express informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCV seroprevalence
Time frame: at inclusion (cross-sectional survey)
proportion of individuals with a past or present HCV infection (rapid test)
1 secondary outcome
Chronic hepatitis C prevalence
Time frame: at inclusion (cross-sectional survey)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, Past or Present and Chronic Hepatitis c, run by ANRS, Emerging Infectious Diseases at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV seroprevalence (time frame: at inclusion (cross-sectional survey)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.