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Background <p>Improving treatment uptake among people with chronic hepatitis B (CHB) infection who live outside urban centres is crucial to achieving the World Health Organization (WHO) elimination targets. Furthermore, as the number of deaths due to hepatitis B in Africa is rising, there is a need for new models of decentralized care adapted to the local context. The main aim of this study is to compare three different models of decentralized care for CHB treatment in Ethiopia, both from a clinical perspective and an implementation perspective.</p> Methods <p>This will be prospective cohort study comparing three models of decentralized care for the management of CHB in Ethiopia. The first model (“standard model”) utilizes the current WHO guidelines for CHB management. The second model (“simplified model”) offers treatment to all individuals with CHB except those with a completely normal baseline assessment, and the third model (“test-and-treat model”) provides treatment to all individuals with CHB.</p> <p>The study will enroll 4,500 individuals with CHB over a one-year period across six study sites in Ethiopia. All patients will be followed up for 3 years, and the primary outcome is death or liver failure. The three models will be compared using a Cox proportional hazards regression model adjusting for potential confounders.</p> <p>Additionally, we will design adequate implementation strategies to address barriers and facilitators to implementation. We will design, implement and evaluate a policy toolbox that will ensure local adoption and implementation, using a co-creation approach, bringing together policymakers, politicians, healthcare personnel and patients, to come up with adequate policy implementation strategies for their contexts.</p> Discussion <p>From a public health perspective, identifying a simple, feasible and effective model of decentralized CHB care would be a key step to reduce liver-related mortality on the African continent. This study may have important policy implications and is expected to inform national and international hepatitis B elimination efforts in low- and middle income countries (LMICs).</p> Trial registration <p>ClinicalTrials.gov, NCT06586983. Registered on September 4, 2024.</p>

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Decentralization of hepatitis B care in sub-Saharan Africa: study protocol for a prospective cohort assessing three models of care in rural Ethiopia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月30日

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  • Kristian Braathen Malme,
  • Nega Berhe,
  • Fufa Hunduma,
  • Hailemichael Desalegn,
  • Asgeir Johannessen

摘要

Background

Improving treatment uptake among people with chronic hepatitis B (CHB) infection who live outside urban centres is crucial to achieving the World Health Organization (WHO) elimination targets. Furthermore, as the number of deaths due to hepatitis B in Africa is rising, there is a need for new models of decentralized care adapted to the local context. The main aim of this study is to compare three different models of decentralized care for CHB treatment in Ethiopia, both from a clinical perspective and an implementation perspective.

Methods

This will be prospective cohort study comparing three models of decentralized care for the management of CHB in Ethiopia. The first model (“standard model”) utilizes the current WHO guidelines for CHB management. The second model (“simplified model”) offers treatment to all individuals with CHB except those with a completely normal baseline assessment, and the third model (“test-and-treat model”) provides treatment to all individuals with CHB.

The study will enroll 4,500 individuals with CHB over a one-year period across six study sites in Ethiopia. All patients will be followed up for 3 years, and the primary outcome is death or liver failure. The three models will be compared using a Cox proportional hazards regression model adjusting for potential confounders.

Additionally, we will design adequate implementation strategies to address barriers and facilitators to implementation. We will design, implement and evaluate a policy toolbox that will ensure local adoption and implementation, using a co-creation approach, bringing together policymakers, politicians, healthcare personnel and patients, to come up with adequate policy implementation strategies for their contexts.

Discussion

From a public health perspective, identifying a simple, feasible and effective model of decentralized CHB care would be a key step to reduce liver-related mortality on the African continent. This study may have important policy implications and is expected to inform national and international hepatitis B elimination efforts in low- and middle income countries (LMICs).

Trial registration

ClinicalTrials.gov, NCT06586983. Registered on September 4, 2024.