Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: Cluster and Individually Randomised Controlled Implementation Trial and Economic Evaluation in Kenya
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Proportion of eligible children who received 3 courses of PDMC
研究概览
简要总结
The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya.
The actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.
详细描述
Study design:
A multi-centre, 2-arm, cluster-randomised trial evaluating two health system delivery strategies and a 3-arm nested individually randomised trial evaluating two new intervention strategies to enhance end-user adherence to post discharge malaria chemoprevention (PDMC) with dihydroartemisinin-piperaquine compared to the standard of care without adherence strategies.
Study sites: Health facilities with blood transfusion services in malaria-endemic areas in western Kenya.
Study Population:
Cluster inclusion criteria: health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria. Exclusion criteria: primary health facilities without subservient lower-level health facilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.
- •>=40 children per year admitted with severe anaemia or severe malaria
- •Agreement to participate by facility management
- •Located in areas with moderate to high malaria transmission
- •INDIVIDUAL PARTICIPANTS
- •Aged <10 years of both sexes
- •Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and/or the presence of microscopy or RDT confirmed Plasmodium infection
排除标准
- •- Health facilities without subservient lower-level health facilities
- •INDIVIDUAL PARTICIPANTS
- •Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)
- •Sickle cell anaemia/sickle cell disease
- •Body weight <5 kg
- •HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.
结局指标
主要结局
Proportion of eligible children who received 3 courses of PDMC
时间窗: 2, 6 and 10 weeks post discharge
Proportion of eligible participants who received all 3 indicated PDMC courses from Ministry of Health staff
Proportion of study children who adhered to 3 PDMC courses (9 doses)
时间窗: 2, 6 and 10 weeks (days 1-3) post discharge
Proportion of children with complete adherence to the full PDMC regimen (3 courses × 3 doses = 9 total doses)
次要结局
- Proportion of children who are readmitted with malaria(0-14 weeks post discharge)
- Proportion of children who are readmitted with any cause(0-14 weeks post discharge)
- Proportion of children who die within 14 weeks of discharge(0-14 weeks post discharge)
- Incidence of serious adverse events(0-14 weeks post discharge)
- Cost-effectiveness(0-14 weeks post discharge)
- User and provider perceptions of acceptability and feasibility(Trial month 6+)