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临床试验/NCT06586983
NCT06586983招募中不适用

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

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2024年9月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,500
试验地点
1
主要终点
Death or liver decompensation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (at least 18 years of age) who is HBsAg positive.

排除标准

  • Below 18 years of age.
  • Negative HBsAg rapid test at screening visit.
  • Other disease with short life expectancy (disseminated cancer etc.)

研究组 & 干预措施

Standard model ("treat only if")

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

干预措施: Tenofovir Disoproxil Fumarate (Drug)

Inclusive model ("treat all except")

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.

干预措施: Tenofovir Disoproxil Fumarate (Drug)

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

All HBsAg positive patients will receive treatment.

干预措施: Tenofovir Disoproxil Fumarate (Drug)

结局指标

主要结局

Death or liver decompensation

时间窗: 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.

次要结局

  • Linkage to care(3 years)
  • Loss to follow-up(3 years)
  • Viral suppression(3 years)
  • HIV incidence(3 years)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asgeir Johannessen

Researcher / project manager

The Hospital of Vestfold

研究点 (1)

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