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
- 1
- 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.
研究组 & 干预措施
Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)
Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses
干预措施: SMS reminders; adherence support strategy a (Other)
Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)
Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses
干预措施: Community Health Promoters (CHP) home visits; adherence support strategy b (Other)
Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)
Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses
干预措施: No reminders; adherence support strategy c (Other)
Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)
Delivery of all three courses of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge from the admitting facility.
干预措施: SMS reminders; adherence support strategy a (Other)
Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)
Delivery of all three courses of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge from the admitting facility.
干预措施: Community Health Promoters (CHP) home visits; adherence support strategy b (Other)
Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)
Delivery of all three courses of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge from the admitting facility.
干预措施: No reminders; adherence support strategy c (Other)
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+)