'SCHOOL-BASED TREATMENT WITH ACT TO REDUCE TRANSMISSION' (START-IPT): Evaluation of the Community Impact of Intermittent Preventive Treatment for Malaria in Ugandan Children: a Cluster Randomised Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10,746
- 试验地点
- 1
- 主要终点
- Parasite prevalence measured by microscopy in final community survey
研究概览
简要总结
We propose to evaluate the community-level impact of intermittent preventive treatment (IPT) for malaria in schoolchildren on clinical outcomes and malaria transmission, using a cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be administered to schoolchildren monthly for up to six rounds of treatment during one school year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito vectors. Our proposal also includes health service research to evaluate the potential feasibility of taking the programme to scale, which will guide future research and implementation of the intervention, and help shape policies in Uganda and elsewhere in Africa.
详细描述
Study objective: The primary objective of the study is to evaluate the impact of IPT for malaria in schoolchildren using monthly DP, as compared with the current standard of care (no IPT), on community-level indicators of malaria transmission. We will test the hypothesis that malaria transmission, as measured by the prevalence of asexual parasitaemia and the entomological inoculation rate (EIR), will be lower in communities surrounding the intervention schools, than those surrounding the control schools.
Study site: The study will be conducted in Jinja district, Uganda.
Clusters: A cluster will be defined as one primary day school plus the 100 closest households surrounding the school. The clusters will be defined prior to randomisation using digitally enumerated maps. We plan to include approximately 84 clusters in the study, with one school per cluster; half will be randomised to the IPT intervention, and half to control.
Randomisation: Randomisation will be conducted by the trial statistician, who is not directly involved in the field activities. Primary schools will be stratified by type of ownership (public vs private). Restricted randomisation will be employed to ensure balance on type of school and geographical location.
Study population: The intervention will be delivered to children attending participating primary schools that are randomised to the intervention group.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student enrolled in a participating intervention school.
- •Willingness of parent/guardian to provide written informed consent.
- •Provision of written assent by the student (aged 8 years or above).
排除标准
- •Age < 5 years
- •Known allergy or history of adverse reaction to DP
- •Menarche in female students
- •Weight < 11 kg
- •History of cardiac problems or fainting
- •Family history of long QT syndrome
- •Current use of medications known to prolong the QT interval
- •Not able to locate parent or guardian, after at least three attempts including parent/teacher association (PTA) meetings and home visits
- •Not able to locate the student at school, after at least three attempts
研究组 & 干预措施
Intermittent preventive treatment (IPT)
Dihydroartemisinin-piperaquine (DP)
干预措施: Dihydroartemisinin-piperaquine (DP) (Drug)
结局指标
主要结局
Parasite prevalence measured by microscopy in final community survey
时间窗: Approximately 1-4 months after completion of the intervention
Proportion of thick blood smears that are positive for asexual parasites, as measured by microscopy.
次要结局
- Parasite prevalence measured by microscopy in the final school survey(During the final 1 month of the intervention)
- Entomologic inoculation rate (EIR) in the entomology survey(Over approximately 1 year)
研究者
Sarah Staedke
Principal Investigator
London School of Hygiene and Tropical Medicine