At home
Niakhar, Fatick, Senegal
NCT Number: NCT03215732
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.
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Notify Me6 month and older
All sexes
Observational
Niakhar, Fatick, Senegal
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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).
Time frame: At baseline
HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody
Time frame: At baseline
HBs Ag positivity
Time frame: At baseline
HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody
Time frame: At baseline
Titration of anti-HBs antibody > 10 UI/l among vaccinated participants
Time frame: 6 months
Rate of deaths in the area
Time frame: 6 months
Rate of HBV-related hospitalizations/healthcare use in the area
Time frame: 6 months
Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households
Time frame: At baseline
Number of HBV-chronic individuals eligible to HBV treatment (according to WHO criteria) in the area, extrapolation to the needs in other areas of Senegal
Time frame: 6 months
Use of Markov simulation models
Time frame: 6 months
Use of Markov simulation models
Time frame: 6 months
Use 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)
ANRS, Emerging Infectious Diseases
Other Gov
Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal
Acronym: AMBASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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