Clinical trial NCT03215732: Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal
Official title: Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Research for Development, France
First posted: 2017-07-12
Enrollment: 3119
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of chronic HBV infection
timeFrame: At baseline
Secondary outcomes:
measure: Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age
timeFrame: At baseline
measure: HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)
timeFrame: At baseline
measure: HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)
timeFrame: At baseline
measure: Mortality associated with chronic HBV infection in the Niakhar area
timeFrame: 6 months
measure: Morbidity associated with chronic HBV infection in the Niakhar area
timeFrame: 6 months
measure: Quality of life and living conditions of HBV-infected individuals and of their households
timeFrame: 6 months
measure: HBV treatment needs in the Niakhar area and in the country
timeFrame: At baseline
measure: Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment
timeFrame: 6 months
measure: Number of QALYs gained with different scenario of access to HBV treatment
timeFrame: 6 months
measure: Total cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Niakhar
country: Senegal
facility: At home
state: Région De Fatick
Study officials:
affiliation: Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France
name: Sylvie BOYER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coste M, De Seze M, Diallo A, Carrieri MP, Marcellin F, Boyer S; ANRS 12356 AmBASS Study Group. Burden and impacts of chronic hepatitis B infection in rural Senegal: study protocol of a cross-sectional survey in the area of Niakhar (AmBASS ANRS 12356). BMJ Open. 2019 Jul 17;9(7):e030211. doi: 10.1136/bmjopen-2019-030211.