Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenofovir Disoproxil Fumarate.
- Who it may be relevant to
- Registry conditions: Hepatitis B. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Tenofovir Disoproxil Fumarate
300 mg po OD
Primary outcome measures
- Death or liver decompensation [Time frame: 3 years]
Secondary outcome measures (4)
- Linkage to care [Time frame: 3 years]
- Loss to follow-up [Time frame: 3 years]
- Viral suppression [Time frame: 3 years]
- HIV incidence [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Adult (at least 18 years of age) who is HBsAg positive.
Exclusion criteria
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ethiopia · 1 center
- Addis Ababa University — Addis Ababa
Publications
- Malme KB, Berhe N, Hunduma F, Desalegn H, Johannessen A. Decentralization of hepatitis B care in sub-Saharan Africa: study protocol for a prospective cohort assessing three models of care in rural Ethiopia. BMC Health Serv Res. 2025 Sep 30;25(1):1223. doi: 10.1186/s12913-025-13340-1. PMID 41029661
Identifiers
NCT: NCT06586983 · 656480