Chronic Hepatitis bAMBASSNCT03215732
Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal
An observational study of Chronic Hepatitis b, run by ANRS, Emerging Infectious Diseases at 1 site in Senegal.
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- HBV testing with dried blood spots (DBS) technique
- How many people
- 3,119 participants
- Where
- 1 siteSenegal
- Study dates
- 19 Oct 2017to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
- Being aged of at least 6 months
- Giving informed consent to participate in the research
Who cannot join
- Being an adult unable to sign informed consent
- Being a child whose parents or legal guardian is not present in the household at the time of the survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Hepatitis b
- Being tested
- HBV testing with dried blood spots (DBS) technique
- Keywords
- prevalence, vaccine coverage, risk factors, morbidity, mortality, quality of life, economic vulnerability, food security, treatment needs, decentralized care, health costs, caregivers training
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV testing with dried blood spots (DBS) techniqueDiagnostic test
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic HBV infection
HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody
Measured: At baseline
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: At baseline
Mortality associated with chronic HBV infection in the Niakhar area
Rate of deaths in the area
Measured: 6 months
Morbidity associated with chronic HBV infection in the Niakhar area
Rate of HBV-related hospitalizations/healthcare use in the area
Measured: 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
Measured: 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
Measured: At baseline
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment
Use of Markov simulation models
Measured: 6 months
Number of QALYs gained with different scenario of access to HBV treatment
Use of Markov simulation models
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start19 Oct 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,119 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institute of Research for Development, France
- Responsible party
- Sponsor
- Investigators
- Sylvie BOYER, Dr, Principal investigator, Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215732
- Sponsor's protocol ID
- ANRS 12356 AMBASS
- Acronym
- AMBASS
- Status last verified
- Sep 2019
- First submitted
- 10 Jul 2017
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Djaogol T, Perieres L, Marcellin F, Diouf A, Carrieri MP, Diallo A, Boyer S; ANRS 12356 AmBASS Study Group. Hepatitis B prevention and treatment needs in women in Senegal (ANRS 12356 AmBASS survey). BMC Public Health. 2023 May 5;23(1):825. doi: 10.1186/s12889-023-15710-y.
PubMed 37143029Coste 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.
PubMed 31320358
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal
- ClinicalTrials.gov ID
- NCT03215732
- Acronym / sponsor ID
- AMBASS / ANRS 12356 AMBASS
- Conditions
- Chronic Hepatitis b
- Keywords
- prevalence, vaccine coverage, risk factors, morbidity, mortality, quality of life, economic vulnerability, food security
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,119 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institute of Research for Development, France
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
- Being aged of at least 6 months
- Giving informed consent to participate in the research
Key exclusion criteria (2 listed)
- Being an adult unable to sign informed consent
- Being a child whose parents or legal guardian is not present in the household at the time of the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBV testing with dried blood spots (DBS) techniqueSurvey participants will be tested at home for chronic HBV infection using the DBS technique (collection of drops of whole blood dried onto filter paper). | Diagnostic test | – |
Primary outcome
Prevalence of chronic HBV infection
Time frame: At baseline
HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody
10 secondary outcomes
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
HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)
Time frame: At baseline
HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)
Time frame: At baseline
Mortality associated with chronic HBV infection in the Niakhar area
Time frame: 6 months
Morbidity associated with chronic HBV infection in the Niakhar area
Time frame: 6 months
Quality of life and living conditions of HBV-infected individuals and of their households
Time frame: 6 months
HBV treatment needs in the Niakhar area and in the country
Time frame: At baseline
Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment
Time frame: 6 months
Number of QALYs gained with different scenario of access to HBV treatment
Time frame: 6 months
Total cost
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 37143029Djaogol T, Perieres L, Marcellin F, Diouf A, Carrieri MP, Diallo A, Boyer S; ANRS 12356 AmBASS Study Group. Hepatitis B prevention and treatment needs in women in Senegal (ANRS 12356 AmBASS survey). BMC Public Health. 2023 May 5;23(1):825. doi: 10.1186/s12889-023-15710-y.
- Derived from this study: PubMed 31320358Coste 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie BOYER, Dr principal investigator
Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by ANRS, Emerging Infectious Diseases at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of chronic HBV infection (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.