Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
- Registration Number
- NCT06586983
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The goal of this observational study is to study models of care for decentralized hepatitis B treatment in Ethiopia.
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.
- Detailed Description
Chronic hepatitis B (CHB) is a major health problem globally, and in Ethiopia 5-10 % of the general population are infected with hepatitis B. In the absence of treatment, 15-40 % of these will die from its complications. Antiviral therapy effectively prevents disease progression and death in CHB. However, In low-income countries antiviral treatment is rarely available due to complex treatment guidelines, poor laboratory capacity, restrictions on antiviral treatment and lack of public funding.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4500
- Adult (at least 18 years of age) who is HBsAg positive.
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard model ("treat only if") Tenofovir Disoproxil Fumarate 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 Inclusive model ("treat all except") Tenofovir Disoproxil Fumarate 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. Test-and-treat model ("treat all") Tenofovir Disoproxil Fumarate All HBsAg positive patients will receive treatment.
- Primary Outcome Measures
Name Time Method Death or liver decompensation 3 years Deaths will be verified by tracing patients who miss appointments. Liver decompensation will be detected clinically and with liver function test assessed every 6-12 months.
- Secondary Outcome Measures
Name Time Method Linkage to care 3 years Proportion of HBsAg positive patients on community screening that are linked to treatment center.
Loss to follow-up 3 years Proportion of patients lost from care despite attempts of tracing patients who misses appointments.
Viral suppression 3 years Proportion of patients with viral suppression, measured by HBV DNA test after 3 years in patients who receive treatment.
HIV incidence 3 years Proportion of patients with deteced HIV infection during the 3 year follow-up.
Trial Locations
- Locations (1)
Addis Ababa University
🇪🇹Addis Ababa, Ethiopia