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

Completed

• Conditions: Chronic Hepatitis b

• Registration Number: NCT03215732
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2017-10-19
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3119

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Morbidity associated with chronic HBV infection in the Niakhar area	6 months	Rate of HBV-related hospitalizations/healthcare use in the area
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment	6 months	Use of Markov simulation models
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
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
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 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)

Trial Locations

Locations (1)

At home; 🇸🇳 Niakhar, Région De Fatick, Senegal