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

Chronic Hepatitis b Clinical Trial

— AMBASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215732
• Other study ID #: ANRS 12356 AMBASS
• Status: Completed
• Start date: October 19, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3119
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Diagnostic Test:
• HBV testing with dried blood spots (DBS) technique
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).

Locations

Country	Name	City	State
Senegal	At home	Niakhar	Région De Fatick

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Institute of Research for Development, France

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of chronic HBV infection	HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody	At baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality associated with chronic HBV infection in the Niakhar area	Rate of deaths in the area	6 months
Secondary	Morbidity associated with chronic HBV infection in the Niakhar area	Rate of HBV-related hospitalizations/healthcare use in the area	6 months
Secondary	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
Secondary	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
Secondary	Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment	Use of Markov simulation models	6 months
Secondary	Number of QALYs gained with different scenario of access to HBV treatment	Use of Markov simulation models	6 months
Secondary	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