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NCT Number: NCT03215732

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

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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Key information

About this study

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

Who can participate

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

Treatment and study plan

HBV testing with dried blood spots (DBS) technique

Diagnostic Test

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).

Primary outcomes

  1. Prevalence of chronic HBV infection

    Time frame: At baseline

    HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody

Secondary outcomes

  1. Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age

    Time frame: At baseline

    HBs Ag positivity

  2. HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)

    Time frame: At baseline

    HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody

  3. HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)

    Time frame: At baseline

    Titration of anti-HBs antibody > 10 UI/l among vaccinated participants

  4. Mortality associated with chronic HBV infection in the Niakhar area

    Time frame: 6 months

    Rate of deaths in the area

  5. Morbidity associated with chronic HBV infection in the Niakhar area

    Time frame: 6 months

    Rate of HBV-related hospitalizations/healthcare use in the area

  6. Quality of life and living conditions of HBV-infected individuals and of their households

    Time frame: 6 months

    Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households

  7. HBV treatment needs in the Niakhar area and in the country

    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

  8. Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment

    Time frame: 6 months

    Use of Markov simulation models

  9. Number of QALYs gained with different scenario of access to HBV treatment

    Time frame: 6 months

    Use of Markov simulation models

  10. Total cost

    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)

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Institute of Research for Development, France

Registry information

Official study title

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

Acronym: AMBASS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2017
Registry last updated
Sep 9, 2019

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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