Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
NCT ID: NCT06586983
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4500 participants
OBSERVATIONAL
2024-09-04
2028-09-05
Brief Summary
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Three different models of decentralized HBV care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in Ethiopia. Treatment will be given for free to patients who meet the treatment criteria. We will compare clinical outcome, laboratory outcomes and programmatic outcome measures between the 3 models.
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Detailed Description
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In 2015, we set up a pilot treatment program for CHB at a tertiary hospital in Addis Ababa, Ethiopia. In 2021/22, this program was extended to four regional secondary hospitals to study simplified CHB care in a low-income country. With the present study we aim to decentralize CHB therapy to rural settings, which will be essential to achieve universal access to antiviral therapy in Africa. We will study different treatment models, each of which has its theoretical pros and cons: i) standard model ("treat only if…"), ii) inclusive model ("treat all except…"), and iii) test-and-treat ("treat all"). The primary endpoint will be death or liver decompensation, and secondary endpoints will be programmatic and laboratory success indicators. Moreover, we will study the cost-effectiveness of these decentralized models and compare with the tertiary/secondary hospital-based model.
Implementation research, such as our study, is of vital importance to respond to the research gaps identified by the World Health Organization in hepatitis B care. Our study is expected to directly inform international hepatitis B guidelines and will be a major contribution to the efforts to eliminate viral hepatitis as a public health threat by 2030.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard model ("treat only if")
HBsAg positive patients will be eligible for treatment of they fulfill one of the following criteria:
i) Clinically diagnosed cirrhosis; or ii) APRI ≥0.5; or iii) Persistently elevated ALT \>40 U/L; or iv) Co-infection with HCV or HDV; or v) Family history of HCC/cirrhosis; or vi) Relevant co-morbidity
Tenofovir Disoproxil Fumarate
300 mg po OD
Inclusive model ("treat all except")
HBsAg positive patients will receive treatment, except if APRI ≤0.3 and no clinical signs/symptoms of cirrhosis and no risk factors for liver disease.
Tenofovir Disoproxil Fumarate
300 mg po OD
Test-and-treat model ("treat all")
All HBsAg positive patients will receive treatment.
Tenofovir Disoproxil Fumarate
300 mg po OD
Interventions
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Tenofovir Disoproxil Fumarate
300 mg po OD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Negative HBsAg rapid test at screening visit.
* Other disease with short life expectancy (disseminated cancer etc.)
18 Years
ALL
No
Sponsors
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Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
UNKNOWN
Addis Ababa University
OTHER
Sykehuset i Vestfold HF
OTHER
St. Paul's Hospital Millennium Medical College, Ethiopia
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Asgeir Johannessen
Researcher / project manager
Principal Investigators
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Asgeir Johannessen, MD PhD
Role: STUDY_DIRECTOR
The Hospital of Vestfold
Nega Berhe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Addis Ababa University
Locations
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Addis Ababa University
Addis Ababa, Addis Ababa, Ethiopia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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656480
Identifier Type: -
Identifier Source: org_study_id
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