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临床试验/NCT03963869
NCT03963869已完成不适用

A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 2,463 人开始时间: 2019年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,463
试验地点
2
主要终点
Parasite species

研究概览

简要总结

The Odisha State Malaria Control Program (India) has introduced 'malaria camps' where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (LLINs) and indoor residual spraying (IRS), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. The long-term goal of this project is to evaluate the effectiveness of malaria camps (MCs) by determining if they reduce malaria, and to characterize malaria transmission in MCs.

详细描述

The persistently high malaria burden in the remote forested areas of Odisha, India has led to the introduction of 'malaria camps' by the Odisha State Malaria Control Program where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (LLINs) and indoor residual spraying (IRS), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. The camps appear to be very effective but this is hard to assess in the context of ongoing changes such as LLIN introduction. The long-term goal of this project is to evaluate the effectiveness of malaria camps (MCs) by determining if they reduce malaria, and to characterize malaria transmission in MCs. The major objective to achieve this is through a quasi-experimental study (i.e., pretest-post-test control group design) of the effectiveness of the intervention, to determine if MCs reduce the prevalence of clinical and asymptomatic malaria as detected by PCR. In the first year, villages will be assigned across three study arms: arm 1 to receive new MCs; arm 2 is a control with no MCs but with standard malaria control; and arm 3 consists of villages already in receipt of MCs to study longer term effects. In the second year, both arm 1 and arm 2 villages will receive the intervention (i.e., a non-randomized stepped-wedge design). MC effectiveness will be evaluated from epidemiologic surveys and PCR detection of malaria prevalence with and without MCs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Year 至 69 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent by individuals greater than 17 years old, or consent by a parent/guardian of children 1-6 years old, or assent of individuals from 7-17 years old along with consent from his or her parent or legal guardian.
  • A complete understanding of study procedures/protocols, as delineated in the consent and assent forms and information sheets.
  • Individuals have the ability and are willing to comply with study procedures for the entire length of the study.

排除标准

  • Individuals less than 12 months or more than 69 years of age will be excluded.
  • Persons who do not understand the study or are physically unable to make monthly visits.

结局指标

主要结局

Parasite species

时间窗: 24 months

The standard molecular method of (conventional) PCR + gel electrophoresis will be used to measure parasite species. All reactions are run with Plasmodium positive controls and negative controls. 10% of samples are QC-ed at second independent site.

Parasite presence

时间窗: 24 Months

The standard molecular method of (conventional) PCR + gel electrophoresis will be used to measure parasite presence. All reactions are run with Plasmodium positive controls and negative controls. 10% of samples are QC-ed at second independent site. The results can be continuous and categorical. Continuous variables will be transformed into categorical variables, so that infections can be sub-divided into symptomatic or asymptomatic.

次要结局

  • Gametocyte density(24 Months)
  • BMI(24 months)
  • Mid-upper arm circumference(24 months)
  • Plasmodium-specific serology(24 months)
  • Malaria as detected by RDT(24 months)
  • Hemoglobin(24 months)
  • Plasmodium parasite genomic epidemiology(24 months)
  • Body temperature(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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