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

Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection 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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Diagnostic test: HBV testing with dried blood spots (DBS) technique

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

• Study Type: Observational
• Enrollment (Actual): 3119

Contacts and Locations

Study Locations

• Senegal
  • Région De Fatick
    • Niakhar, Région De Fatick, Senegal
      • At home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of chronic HBV infection	HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	At baseline
Mortality associated with chronic HBV infection in the Niakhar area	Rate of deaths in the area	6 months
Morbidity associated with chronic HBV infection in the Niakhar area	Rate of HBV-related hospitalizations/healthcare use in the area	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	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	At baseline
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment	Use of Markov simulation models	6 months
Number of QALYs gained with different scenario of access to HBV treatment	Use of Markov simulation models	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)	6 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institute of Research for Development, France
• Investigators: Principal Investigator: Sylvie BOYER, Dr, Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; risk factors; prevalence; mortality; health costs; morbidity; vaccine coverage; food security; economic vulnerability; treatment needs; decentralized care; caregivers training
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: ANRS 12356 AMBASS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No