Comparison of Two Strategies for the Delivery of Intermittent Preventive Treatment in Children (IPTc) in an Area of Seasonal Malaria Transmission
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14,000
- 试验地点
- 2
- 主要终点
- Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period.
研究概览
简要总结
Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.
详细描述
- OBJECTIVES
The objective of this trial is to study the effectiveness and cost-effectiveness of two approaches to the administration of intermittent preventive treatment to Gambian children - distribution by village volunteers or through EPI trekking teams.
5 STUDY DESIGN AND METHODOLOGY
The unit of randomization will be the catchment population of the monthly EPI trekking clinics. There are 33 trekking clinics in total on the south bank of URD of which 27 are rural. The rural trekking clinics will be selected for randomization. 26 rural clusters (two will be merged to give an even number) will be stratified by health facility catchment area (Gambissara, Basse, Fatoto). Constrained randomization will be used to ensure balance within strata with regard to distribution of PHC key villages and population size.
The bednet coverage in URD is estimated to 65%. However, during the enumeration, details of bed net usage by the community will be assessed. In collaboration with the malaria control programme, we will facilitate the provision of bed nets to households without one. At the beginning of the rainy season permethrin will be provided to all households with bednets.
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
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 3 months and 5 years at enrolment.
- •Informed consent obtained from parents or legal guardians.
- •No current participation in another malaria intervention trial.
排除标准
- •Previous adverse reaction to treatment with SP or amodiaquine. If this is unknown, then a history of allergic reaction to any drug.
结局指标
主要结局
Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period.
时间窗: during malaria transmission period
Cost-effectiveness of the delivery system.
时间窗: during the study period
次要结局
- Coverage of IPTC(During the study period)
- the proportion of children who received three IPT courses on schedule;(during the study period)
- the proportion of children who received partial or off-schedule IPT courses(during the study period)
- the proportion of children with no IPT.(during the study period)
- Unit cost of delivery per fully adherent child.(during the study period)
- Incremental cost-effectiveness ratio for each systems of delivery.(During the study period)
- Mean Hb (g/dl)(at the end of malaria transmission)
- Prevalence of malaria parasitaemia(At the end of the malaria transmission season)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine