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NCT Number: NCT06586983

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Tenofovir disoproxil fumarate

Drug

300 mg po OD

Primary outcomes

  1. Death or liver decompensation

    Time frame: 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 outcomes

  1. Linkage to care

    Time frame: 3 years

    Proportion of HBsAg positive patients on community screening that are linked to treatment center.

  2. Loss to follow-up

    Time frame: 3 years

    Proportion of patients lost from care despite attempts of tracing patients who misses appointments.

  3. Viral suppression

    Time frame: 3 years

    Proportion of patients with viral suppression, measured by HBV DNA test after 3 years in patients who receive treatment.

  4. HIV incidence

    Time frame: 3 years

    Proportion of patients with deteced HIV infection during the 3 year follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Asgeir Johannessen, MD PhD

CONTACT

[email protected]

+4797983264

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Addis Ababa University
  • Norges ForskningsrÃ¥d, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
  • St. Paul's Hospital Millennium Medical College, Ethiopia
  • Sykehuset i Vestfold HF

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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