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临床试验/NCT01130155
NCT01130155Unknown不适用

IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 33,900 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
33,900
试验地点
1
主要终点
Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs

研究概览

简要总结

It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2 key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii) targeting ACTs to patients shown to have malaria parasitaemia.

The Tanzanian Government has secured funding to address both ACT access and targeting on a national scale. Access is to be improved through the distribution of subsidised ACTs through private facilities and retail drug shops under the Affordable Medicines Facility-malaria (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid diagnostic tests (RDTs) in health facilities at every level of the system.

This study will evaluate these two interventions in 3 rural regions of Tanzania which are all expected to receive both interventions during the study period. The investigators will assess the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and public health impact using a pre-post plausibility design based on before and after household, health facility and outlet surveys. The null hypothesis is that the interventions will have no impact on the coverage of prompt effective treatment for fever and malarial. In addition, the investigators will estimate the cost and cost-effectiveness of implementation from a health system and household perspective. Finally the investigators will explore the socio-cultural context and other factors that influence the implementation and outcome of the interventions.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Household survey - All consenting and assenting residents available in selected households
  • Health facility survey - patients presenting to selected health facilities with fever or history of fever in the prior 24 hours; Age >= 3 months, or Weight ≥ 5 kg; First visit to this health facility for this illness episode

排除标准

  • Household survey - Children less than 3 months of age will be excluded from providing a blood sample
  • Health facility survey - Signs of severe illness

结局指标

主要结局

Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs

Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs

Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria

Proportion of patients presenting to public health facilities with fever who receive rapid diagnostic test (RDT) for malaria and are appropriately treated according to RDT results

次要结局

  • Percent of patients receiving an ACT that adhered to full dose with correct dose timing
  • Mean and median household cost per febrile episode
  • The accuracy of RDTs performed by health workers
  • Adequacy of health facility resources for diagnosis and treatment of malaria

研究者

研究点 (1)

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