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临床试验/NCT02894294
NCT02894294已完成不适用

Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali

University of Bamako0 个研究点目标入组 1,162 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,162
主要终点
Coverage of SMC

研究概览

简要总结

Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. Our evaluation used a pre-post design with cross-sectional surveys and abstraction of routine health information system data in an intervention district (Kita) where SMC was implemented through the health system, and a comparison district (Bafoulabe) where SMC was not implemented.

详细描述

Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials (RCTs) have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease, and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. A pre-post design was used, with one intervention district, Kita where four rounds of SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine (SP+AQ) took place in August-November 2014, and one comparison district, Bafoulabe. Cross-sectional surveys were carried out in children aged 3-59 months from 30 randomly selected localities (15/district) at baseline and in follow-up to assess the impact of SMC on malaria parasitemia, fever, malaria illness, and anemia. The baseline survey was performed in July 2014 prior to the start of SMC implementation and the post-intervention (follow-up) surveys took place in December 2014. Blood samples were collected for thick/thin smears for malaria and hemoglobin measurement in two cross-sectional surveys, one prior to SMC in July 2014 and one after SMC in December 2014. The impact on malaria morbidity was assessed using routine data on confirmed malaria cases extracted from the registers by the research team in nine of the 47 community health centers in Kita and seven of the 24 health centers in Bafoulabe. Cross-sectional surveys were also carried out about 7 days after each of the four rounds of SMC to assess caregivers' adherence to the administration of SMC drugs and determine the frequency of adverse events in the intervention district of Kita. Coverage was assessed by cross-sectional in children 3-59 months in 30 randomly selected clusters in the district of Kita using interview of the caregivers and information on the SMC card in December 2014.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
3 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children age 3-59 months
  • Residence in the study areas
  • Provision of inform consent

排除标准

  • Age < 3 months or >= 60 months
  • Not resident in the study areas
  • No provision of inform consent

结局指标

主要结局

Coverage of SMC

时间窗: Four months (August to November in 2014)

Proportion of the children aged 3-59 months at the time of SMC who received the three days' treatment of SMC during that specific round

Change in malaria infection from baseline

时间窗: December 2014 (one month post last round of SMC)

Malaria infection was defined as presence of malaria parasitemia by blood smear

Change in prevalence of malaria illness from baseline

时间窗: December 2014 (one month post last round of SMC)

axillary temperature \>= 37.5o C and blood smear positive for asexual forms of malaria parasites

Adherence to SMC

时间窗: 1-3 days post post first SMC dose

proportion of children who received the second and third dose of AQ at home

次要结局

  • Adverse events(7 days post SMC round in August, September, October and November in 2014)
  • Confirmed malaria cases(six months (July to December))
  • Change in prevalence of anemia at baseline(December 2014 (one month post last round of SMC))
  • Change from baseline in frequency of molecular markers of resistance to SP and AQ(December 2014 (one month post last round of SMC))

研究者

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

Alassane Dicko

Professor

University of Bamako

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