A Trial of Intermittent Preventive Treatment and Home Based Management of Malaria in a Rural Area of The Gambia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,312
- 试验地点
- 1
- 主要终点
- Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period).
研究概览
简要总结
Malaria in African countries remains an important cause of mortality and morbidity among young children. The global malaria control strategies include prompt treatment with an effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying (IRS), and intermittent preventive treatment. However, individually these interventions provide only imperfect protection. Thus, there is a need to investigate whether additional control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312 children under 5 years of age living in villages and hamlets near Farafenni, The Gambia, which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers based in primary health care villages. Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions during the months of September, October and November. In addition, VHWs were trained to administer treatment with coartem to children if they develop symptoms compatible with malaria during the malaria transmission season. The primary end point was the incidence of clinical attacks of malaria detected during the study.
详细描述
Goals and Objectives
- The goal of this project was to determine the degree to which morbidity from malaria can be prevented in children who receive intermittent preventive treatment(IPTc) with SP plus amodiaquine and home based management of malaria with Coartem by village health worker during 2008 malaria transmission season.
- The objective of the project was to conduct an individually randomized trial of IPTc in children who receive HMM in North Bank Region an area where malaria transmission is highly seasonal. This trial will determine whether IPTc adds significant benefit to HMM.
The study was undertaken in a group of 42 villages and hamlets near Farafenni. The villages ranged in size from 46 to 1250 inhabitants. The total population of the rural FDSS catchment area was about 17 000 and that of children under 5 years of age was about 3000. The area has one general hospital, three health centres and two private healthcare clinics. There are 18 rural primary health care (PHC) villages in the study area. PHC villages, each with a population over 400, have mainly been selected plus, occasionally, others located in relatively isolated areas. In all villages, village health workers (VHWs) and traditional birth attendants (TBAs) are selected by the Village Development Committee (VDC) and given 6 to 8 weeks of training with a standardised curriculum on how to treat common conditions such as uncomplicated malaria, ARI, diarrhoeal diseases and minor injuries. Thus, VHWs function as primary health care providers for minor illnesses and injuries for all ages. In addition, the VHW are expected to work as a community-based health educator. TBAs functioned as birth attendants, family planning distributors and health educators. Both TBAs and VHWs were expected to refer serious cases to the local health facility for management. VHWs and TBAs are supervised by Community Health Nurses who oversee circuits of 4 to 10 PHC villages. All rural settlements also have a Medical Research Council(MRC) Village Reporter who carries out sensitization for MRC activities. The bednet coverage in NBR was estimated to be 50%. However, during the study, details of bed net usage by the community were assessed.
Recruitment and randomization:
The study was carried in collaboration with the EPI unit of the Department of State for Health, National Malaria Control Programme and NBR District Health Team. During the preparatory phase of the study, the design and objectives of the study were discussed extensively with the NBR District Team and all health care providers working in the study area. The study team visited all the villages in the study area to explain the objectives of the trial to village elders, opinion leaders, and heads of women's groups, village health workers and traditional birth attendants. This was followed by village meetings, at which the entire community was invited to participate. During these meetings, agreement to participate in the study was obtained from the villagers. In addition, parents or guardians of prospective study subjects in the right age group were visited at home and they were provided with flyers in English and the appropriate local language (Mandinka, Wollof or Fula). Written informed consent was obtained from the parent(s) or guardian(s) before a child was enrolled in the study. Enrolled subjects were provided with a treatment card stamped with a label carrying their name and study number to facilitate identification at each contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 59 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 3 months and 59 months at enrolment.
- •Informed consent obtained from parents or legal guardians.
- •No current participation in another malaria intervention trial
- •Permanent residence in the study area with no intention of leaving during the surveillance period.
排除标准
- •Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
- •Temporary residence in the study area
- •Lack of informed consent
- •Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.
研究组 & 干预措施
SP and amodiaquine
Study subjects received intermittent preventive treatment with SP plus amodiaquine.
干预措施: SP plus amodiaquine (Drug)
SP placebo plus amodiaquine placebo
Intermittent preventive treatment with SP placebo and amodiaquine placebo
干预措施: SP placebo plus amodiaquine placebo (Drug)
结局指标
主要结局
Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period).
时间窗: During the surveillance period (September to December 2008)
次要结局
- prevalence of parasitaemia at the end of malaria transmission season in December 2008(December 2008)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine
