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

NCT03215732 | Completed DMC

• 1 other identifier: ANRS 12356 AMBASS
• Study Type: observational
• Target: 3,119
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of chronic HBV infection

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

  At baseline

Secondary Outcomes (10)

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

  At baseline

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

  At baseline

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

  At baseline

• Mortality associated with chronic HBV infection in the Niakhar area

  6 months

• Morbidity associated with chronic HBV infection in the Niakhar area

  6 months

Interventions

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).

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institute of Research for Development, France: collaborator

Study Sites (1)

At home

Niakhar, Fatick, Senegal

Location

Related Publications (2)

• Djaogol T, Perieres L, Marcellin F, Diouf A, Carrieri MP, Diallo A, Boyer S; ANRS 12356 AmBASS Study Group. Hepatitis B prevention and treatment needs in women in Senegal (ANRS 12356 AmBASS survey). BMC Public Health. 2023 May 5;23(1):825. doi: 10.1186/s12889-023-15710-y.

  PMID: 37143029 DERIVED

• 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.

  PMID: 31320358 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie BOYER, Dr

  Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 12, 2017
• Study Start: October 19, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)