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临床试验/NCT04660110
NCT04660110Unknown3 期

Evaluation of the Household-level Impact of a Single Round of Intermittent Preventive Treatment of Malaria in Schoolchildren: A Randomized Study

Makerere University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年1月28日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
1,500
试验地点
1
主要终点
Parasite prevalence

研究概览

简要总结

The study will evaluate the household-level impact of IPT for malaria in schoolchildren on malaria transmission, using a randomized trial design. Two schools in Busia district will be randomly selected and randomize to either IPT with dihydroartemisinin piperaquine (DP, IPT arm), or standard of care (no intervention). A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals) will be given to the children in the intervention arm. The full dose will be given as oral tablets once a day for 3 consecutive days to all eligible children in the intervention school. Surveys will be conducted in households of 100 randomly selected children in each of the study arms at baseline, one month and three months following the intervention. The target population will include all household members of the selected households.

详细描述

The most promising strategy to address the burden of malaria in school-aged children is intermittent preventive treatment with antimalarials (IPTsc). IPTsc has clearly been demonstrated to improve the health and educational attainment of schoolchildren. While the goal of IPTsc is improving the individual outcomes, reducing infections in schoolchildren, a primary reservoir for human-to-mosquito transmission may reduce overall transmission increasing the benefits and adding value to this intervention. In areas where the burden of malaria remains high despite implementation of currently available tools, IPTsc could act as a complimentary measure to reduce transmission incrementally while decreasing the burden of malaria in a vulnerable, high yield population. However, the benefits of IPTsc specifically targeting transmission reduction, have not widely been evaluated. We will evaluate impact of IPTsc with an antimalarial in schoolchildren on the malaria burden in household members in a high transmission area. The objective is to:

  1. To determine the impact of intermittent preventive treatment of malaria in schoolchildren on malaria transmission at the household, as measured by the prevalence of parasitaemia at the household level.
  2. To determine the impact of intermittent preventive treatment of malaria in schoolchildren on the health of the children as measured by the prevalence of parasitaemia among the children.

Two primary schools will be randomly selected from the list of the schools in Busia district. The list will act as the sampling frame for the school selection. Following the identification of the two schools to participate in the study. The schools will be randomized to either intervention or control arm.

A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals) will be given to the children in the intervention arm. The full dose will be given as oral tablets once a day for 3 consecutive days to all eligible children in the intervention school. The outcome is the prevalence of parasitemia in the schoolchildren and household members. To assess the impact of the intervention in schoolchildren, 216 children in the intervention school and 216 children in the control school will be randomly selected and assessed at baseline, 1 month and 3 months following the intervention. The same children will be assessed at the 3 school surveys. To assess the impact of the intervention on transmission at the household level, we will enroll 476 household members in the intervention arm and 476 household members in the control arm. Assessments will be conducted at baseline, 1 month and 3 months following the intervention.

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

性别
All
接受健康志愿者

入选标准

  • It is a government-run primary school,
  • Has actively enrolled pupils in primary grades 1-7
  • School children
  • Are enrolled at the participating school
  • Have parent/guardian consent to receive medication
  • Provided assent for those > 8 years
  • Have no known allergy to study medication (Dihydroartemisinin piperaquine [DP])
  • Have an adult > 18 years of age
  • Agreement of the household head/designate to provide informed consent to participate in the three household surveys (baseline, 1-month post-intervention, and 3-months post-intervention)
  • Household members
  • Usual resident and present in the household the night before the survey
  • Agreement of resident or parent/guardian to provide informed consent
  • Agreement of children aged 8-17 years to provide assent

排除标准

  • 未提供

研究组 & 干预措施

Intervention arm

Active Comparator

A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals)

干预措施: IPT with Dihydroartemisinin Piperaquine (Drug)

结局指标

主要结局

Parasite prevalence

时间窗: 3 months after the intervention

Parasitemia measured by microscopy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

College of Health Sciences

Lecturer

Makerere University

研究点 (1)

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