Integrating the Guardian Spatial Emanator Within AVENIR II
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- Proportion of eligible households that received spatial emanators
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Spatial Emanator (Device)
结局指标
主要结局
Proportion of eligible households that received spatial emanators
时间窗: 1 month after distribution
Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.
Acceptability of the integrated delivery
时间窗: 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.
Proportion of households with correct product placement
时间窗: 12 months after distribution
Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits
次要结局
- Proportion of households reached with messaging regarding the intervention(During the distribution period (1 week))
- Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs(During the distribution period (1 week))
- Time required per household(During the distribution period (1 week))
- Cost per Guardian delivered(during study preparation and completion (1 year))
- Incidence of malaria-related visits to the CSI by children under 5 years of age(12 month after distribution)