An observational study in Chronic Hepatitis b, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in Senegal. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
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.
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 3,119 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include all individuals who live (even non-permanently) in the sampled households of the Niakhar area for at least 6 months, who are aged of at least 6 months, and who sign informed consent to participate in the survey.
(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).
Prevalence of chronic HBV infection
HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody
Time frame: At baseline
Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age
HBs Ag positivity
Time frame: At baseline
HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)
HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody
Time frame: At baseline
HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)
Titration of anti-HBs antibody \> 10 UI/l among vaccinated participants
Time frame: At baseline
Mortality associated with chronic HBV infection in the Niakhar area
Rate of deaths in the area
Time frame: 6 months
Morbidity associated with chronic HBV infection in the Niakhar area
Rate of HBV-related hospitalizations/healthcare use in the area
Time frame: 6 months
Quality of life and living conditions of HBV-infected individuals and of their households
Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households
Time frame: 6 months
HBV treatment needs in the Niakhar area and in the country
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: At baseline
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment
Use of Markov simulation models
Time frame: 6 months
Number of QALYs gained with different scenario of access to HBV treatment
Use of Markov simulation models
Time frame: 6 months
Total cost
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)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases