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Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal

Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03215732
Acronym
AMBASS
Enrollment
3119
Registered
2017-07-12
Start date
2017-10-19
Completion date
2019-07-31
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b

Keywords

prevalence, vaccine coverage, risk factors, morbidity, mortality, quality of life, economic vulnerability, food security, treatment needs, decentralized care, health costs, caregivers training

Brief summary

This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

Detailed description

The prevalence of chronic HBV infection in Senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors). The prevalence of HBV chronic infection remains undocumented in the general population of Senegal, and its health-related and socio-economic consequences need to be estimated. This research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of Niakhar (located at 135 kms at the East of Dakar). The research includes three phases as follows: (i) Preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey (ii) Collection of data in the general population (iii) Communication of results on HBV status to participants and collection of additional data among HBV chronic individuals

Interventions

DIAGNOSTIC_TESTHBV testing with dried blood spots (DBS) technique

Survey participants will be tested at home for chronic HBV infection using the DBS technique (collection of drops of whole blood dried onto filter paper).

Sponsors

Institute of Research for Development, France
CollaboratorOTHER_GOV
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

(i) Living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the Niakhar zone) (ii) Being aged of at least 6 months (iii) Giving informed consent to participate in the research

Exclusion criteria

(i) Being an adult unable to sign informed consent (ii) Being a child whose parents or legal guardian is not present in the household at the time of the survey

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of chronic HBV infectionAt baselineHBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody

Secondary

MeasureTime frameDescription
HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)At baselineHBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody
HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)At baselineTitration of anti-HBs antibody \> 10 UI/l among vaccinated participants
Mortality associated with chronic HBV infection in the Niakhar area6 monthsRate of deaths in the area
Morbidity associated with chronic HBV infection in the Niakhar area6 monthsRate of HBV-related hospitalizations/healthcare use in the area
Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing ageAt baselineHBs Ag positivity
HBV treatment needs in the Niakhar area and in the countryAt baselineNumber of HBV-chronic individuals eligible to HBV treatment (according to WHO criteria) in the area, extrapolation to the needs in other areas of Senegal
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment6 monthsUse of Markov simulation models
Number of QALYs gained with different scenario of access to HBV treatment6 monthsUse of Markov simulation models
Total cost6 monthsUse of Markov simulation models (with different scenarii of change in access to HBV treatment and amount of the financial contributions of populations, government and international programs)
Quality of life and living conditions of HBV-infected individuals and of their households6 monthsComparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026