Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia

University of Oslo (UIO)

Status: Enrolling

Conditions: Hepatitis B

Treatments: Drug: Tenofovir Disoproxil Fumarate

Study type: Observational

Funder types: Other

Identifiers

NCT06586983

656480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

4,500 participants in 3 patient groups

Standard model ("treat only if")

Description:

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

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Inclusive model ("treat all except")

Description:

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.

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Test-and-treat model ("treat all")

Description:

All HBsAg positive patients will receive treatment.

Treatment:

Drug: Tenofovir Disoproxil Fumarate