Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Tenofovir Disoproxil Fumarate.
- Кому может быть актуально
- Состояния в реестре: Hepatitis B. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Ethiopia
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Tenofovir Disoproxil Fumarate
300 mg po OD
Первичные конечные точки
- Death or liver decompensation [Срок оценки: 3 years]
Вторичные конечные точки (4)
- Linkage to care [Срок оценки: 3 years]
- Loss to follow-up [Срок оценки: 3 years]
- Viral suppression [Срок оценки: 3 years]
- HIV incidence [Срок оценки: 3 years]
Критерии участия
Критерии включения
- Adult (at least 18 years of age) who is HBsAg positive.
Критерии исключения
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Ethiopia · 1 центр
- Addis Ababa University — Addis Ababa
Публикации
- Malme KB, Berhe N, Hunduma F, Desalegn H, Johannessen A. Decentralization of hepatitis B care in sub-Saharan Africa: study protocol for a prospective cohort assessing three models of care in rural Ethiopia. BMC Health Serv Res. 2025 Sep 30;25(1):1223. doi: 10.1186/s12913-025-13340-1. PMID 41029661
Идентификаторы
NCT: NCT06586983 · 656480