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Integrating the Guardian Spatial Emanator Within AVENIR II (GUARD-AV)

2026年7月20日 更新者:University of California, San Francisco

This study will evaluate the implementation of integrating Guardian spatial emanators into the existing AVENIR II azithromycin mass drug administration program in Niger. The objective is to assess whether Guardian can be feasibly, acceptably, and effectively delivered through the same community-based platform already used for door-to-door azithromycin distribution to children 1 to 59 months of age.

Selected health center catchment areas in high-malaria-transmission settings in Niger will be randomized to integrated delivery or non-integrated delivery. The study will measure implementation outcomes including reach, coverage, acceptability, fidelity to protocol, costs, and product placement over time, and will also assess malaria-related clinic visits among children under 5 years of age using routine health facility data

研究概览

地位

尚未招聘

条件

详细说明

Niger is implementing azithromycin mass drug administration for child survival through door-to-door delivery by community health workers to children 1 to 59 months of age every 6 months. In areas with a high burden of seasonal malaria, integrating delivery of Guardian spatial emanators into this existing platform may provide an efficient way to add malaria prevention to an established community-based campaign. Guardian is a passive spatial emanator intended to reduce mosquito exposure indoors. Although spatial emanators have shown protective efficacy in previous studies, there is limited evidence on the feasibility, acceptability, and cost of integrating them into large-scale public health delivery systems in seasonal malaria settings.

This study is a randomized implementation study nested within AVENIR II. Selected Centre de Santé Intégré catchment areas participating in AVENIR II in high-malaria-transmission areas of Niger will be randomized to either integrated delivery of Guardian plus azithromycin mass drug administration or to standard azithromycin mass drug administration without Guardian integration. Within catchment areas assigned to integrated delivery, community health workers will conduct door-to-door visits to eligible households, provide malaria prevention messaging, determine the number of Guardian devices needed for the household, install the devices, and document delivery. Participating health centers in integrated areas will also receive Guardian devices.

The study will evaluate implementation outcomes including the proportion of households reached, the proportion of eligible households and health centers receiving Guardian, the proportion of eligible children receiving azithromycin in integrated and non-integrated areas, time required for delivery, fidelity to protocol, acceptability among households and community health workers, product placement over time, bioefficacy and active ingredient monitoring, and program costs. The study will also compare malaria-related clinic visits among children under 5 years of age in integrated and non-integrated catchment areas using routine health facility data. Data sources will include treatment records, fidelity observations, coverage evaluation surveys, repeated longitudinal monitoring surveys, cost records, and routine clinic data.

研究类型

介入性

注册 (估计的)

150000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Niamey、尼日尔
        • Program National de Santé Oculaire
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Centre de Santé Intégré (CSI) catchment area participating in the AVENIR II azithromycin mass drug administration program
  • Located in a high malaria transmission setting in the study area
  • Randomly selected from the eligible pool for participation
  • Household located within a selected CSI catchment area
  • Verbal consent provided by the head of household for household-level study activities
  • Verbal consent provided by the CSI chief for CSI-level participation

Exclusion Criteria:

  • CSI catchment area not participating in the AVENIR II azithromycin mass drug administration program
  • Household not located within a selected CSI catchment area
  • Refusal of verbal consent by the head of household
  • Refusal of verbal consent by the CSI chief for CSI-level participation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Guardian Spatial Emanator
Eligible households in CSI catchment areas assigned to the intervention will receive Guardian spatial emanators during integrated delivery with azithromycin mass drug administration.
Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.
无干预:No Guardian Spatial Emanator
Eligible households in CSI catchment areas assigned to the comparison group will not receive Guardian spatial emanators and will continue to receive standard azithromycin mass drug administration procedures.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of eligible households that received spatial emanators
大体时间:1 month after distribution
Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.
1 month after distribution
Acceptability of the integrated delivery
大体时间:1 month after distribution
Acceptability of integrated delivery of Guardian spatial emanators with azithromycin mass drug administration as perceived by households and community health workers, assessed by qualitative surveys.
1 month after distribution
Proportion of households with correct product placement
大体时间:12 months after distribution
Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits
12 months after distribution

次要结果测量

结果测量
措施说明
大体时间
Proportion of households reached with messaging regarding the intervention
大体时间:During the distribution period (1 week)
Proportion of households in participating CSI catchment areas that were reached with program messaging about Guardian spatial emanators during the distribution period
During the distribution period (1 week)
Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs
大体时间:During the distribution period (1 week)
Proportion of eligible children who received azithromycin mass drug administration in CSI catchment areas assigned to integrated Guardian delivery and in CSI catchment areas assigned to non-integrated delivery
During the distribution period (1 week)
Time required per household
大体时间:During the distribution period (1 week)
Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.
During the distribution period (1 week)
Cost per Guardian delivered
大体时间:during study preparation and completion (1 year)
Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention
during study preparation and completion (1 year)
Incidence of malaria-related visits to the CSI by children under 5 years of age
大体时间:12 month after distribution
Incidence of malaria-related clinic visits among children under 5 years of age in participating CSI catchment areas, assessed through CSI data collection and aggregation using District Health Information Software 2 (DHIS2)
12 month after distribution

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified data underlying outcomes publications will be made publicly available.

IPD 共享时间框架

Data will be made available after publication of the outcomes and will be made available indefinitely.

IPD 共享访问标准

Once made available, the data will be open access.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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