Actively Recruiting
Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Led by Oslo University Hospital · Updated on 2024-09-19
4500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
N
Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different ways to provide hepatitis B treatment in rural areas of Ethiopia through an observational study. The study aims to compare three models of decentralized hepatitis B care called the standard model, inclusive model, and test-and-treat model. This research is important because chronic hepatitis B affects 5-10% of Ethiopia's population and can lead to serious complications or death without treatment. The study will also assess how these care models perform in real-world settings and their cost-effectiveness compared to hospital-based treatment. The study involves implementing three treatment approaches at primary hospitals or health clinics. The standard model treats patients only if they meet specific criteria such as cirrhosis or co-infections. The inclusive model treats all patients except those with low risk and no symptoms, while the test-and-treat model treats all patients who test positive. Treatment includes antiviral medication Tenofovir Disoproxil Fumarate, given orally once daily. Treatment is provided free to eligible patients meeting the criteria. Participants will be monitored over three years to track clinical outcomes like death or liver problems, as well as laboratory results and program success indicators such as linkage to care, loss to follow-up, viral suppression, and HIV incidence. The research team will collect data on these outcomes regularly to compare the effectiveness of the three models. The study aims to improve access to hepatitis B therapy in low-resource settings and contribute to global efforts to eliminate viral hepatitis by 2030.
CONDITIONS
Brief Title
Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (at least 18 years of age) who is HBsAg positive.
You will not qualify if you...
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who test positive for hepatitis B surface antigen are observed under different treatment models to study decentralized hepatitis B care. Treatment decisions depend on the assigned model and clinical criteria.
Regular visits depending on care model
Trial Site Locations
Total: 1 location
1
Addis Ababa University
Addis Ababa, Addis Ababa, Ethiopia
Actively Recruiting
Research Team
A
Asgeir Johannessen, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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