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

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT03215732

Collaborator

Institute of Research for Development, France (Other)

3,119

Enrollment

Location

21.4

Actual Duration (Months)

146.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	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 Design

Study Type:

Observational

Actual Enrollment :

3119 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 19, 2017

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Outcome Measures

Primary Outcome Measures

Prevalence of chronic HBV infection [At baseline]
HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody

Secondary Outcome Measures

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]
HBs Ag positivity
HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program) [At baseline]
HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody
HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program) [At baseline]
Titration of anti-HBs antibody > 10 UI/l among vaccinated participants
Mortality associated with chronic HBV infection in the Niakhar area [6 months]
Rate of deaths in the area
Morbidity associated with chronic HBV infection in the Niakhar area [6 months]
Rate of HBV-related hospitalizations/healthcare use in the area
Quality of life and living conditions of HBV-infected individuals and of their households [6 months]
Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households
HBV treatment needs in the Niakhar area and in the country [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
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment [6 months]
Use of Markov simulation models
Number of QALYs gained with different scenario of access to HBV treatment [6 months]
Use of Markov simulation models
Total cost [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	At home	Niakhar	Région De Fatick	Senegal

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases
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