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Trial record 65 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03215732
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
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
Estimated Enrollment : 3200 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 : October 19, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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).

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of chronic HBV infection [ Time Frame: At baseline ]
    HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody


Secondary Outcome Measures :
  1. Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age [ Time Frame: At baseline ]
    HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody

  2. HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program) [ Time Frame: At baseline ]
    HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody

  3. HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program) [ Time Frame: At baseline ]
    Titration of anti-HBs antibody > 10 UI/l among vaccinated participants

  4. Mortality associated with chronic HBV infection in the Niakhar area [ Time Frame: 6 months ]
    Rate of deaths in the area

  5. Morbidity associated with chronic HBV infection in the Niakhar area [ Time Frame: 6 months ]
    Rate of HBV-related hospitalizations/healthcare use in the area

  6. Quality of life and living conditions of HBV-infected individuals and of their households [ Time Frame: 6 months ]
    Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households

  7. HBV treatment needs in the Niakhar area and in the country [ Time Frame: 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

  8. Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment [ Time Frame: 6 months ]
    Use of Markov simulation models

  9. Number of QALYs gained with different scenario of access to HBV treatment [ Time Frame: 6 months ]
    Use of Markov simulation models

  10. Total cost [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215732


Contacts
Contact: Aldiouma DIALLO, Dr 221 33 849 35 56 aldiouma.diallo@ird.fr

Locations
Senegal
At home Recruiting
Niakhar, Région De Fatick, Senegal
Contact: Aldiouma Diallo         
Sponsors and Collaborators
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
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
More Information

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03215732     History of Changes
Other Study ID Numbers: ANRS 12356 AMBASS
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
prevalence
vaccine coverage
risk factors
morbidity
mortality
quality of life
economic vulnerability
food security
treatment needs
decentralized care
health costs
caregivers training

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections