Clinical trial NCT06586983: Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Official title: Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Keywords: Liver cirrhosis
Antiviral agents
Liver disease
Resource-limited settings
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norges ForskningsrÃ¥d, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
name: Addis Ababa University
name: Sykehuset i Vestfold HF
name: St. Paul's Hospital Millennium Medical College, Ethiopia
First posted: 2024-09-19
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with a positive HBsAg rapid test are eligible for inclusion.

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.

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.)

Primary outcomes:
measure: Death or liver decompensation
timeFrame: 3 years
Secondary outcomes:
measure: Linkage to care
timeFrame: 3 years
measure: Loss to follow-up
timeFrame: 3 years
measure: Viral suppression
timeFrame: 3 years
measure: HIV incidence
timeFrame: 3 years
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa University
Study officials:
affiliation: The Hospital of Vestfold
name: Asgeir Johannessen, MD PhD
role: STUDY_DIRECTOR
affiliation: Addis Ababa University
name: Nega Berhe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: