Integrating the Guardian Spatial Emanator Within AVENIR II

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Spatial Emanator
  Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.

Первичные конечные точки

• Proportion of eligible households that received spatial emanators [Срок оценки: 1 month after distribution]
• Acceptability of the integrated delivery [Срок оценки: 1 month after distribution]
• Proportion of households with correct product placement [Срок оценки: 12 months after distribution]

Вторичные конечные точки (5)

• Proportion of households reached with messaging regarding the intervention [Срок оценки: During the distribution period (1 week)]
• Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs [Срок оценки: During the distribution period (1 week)]
• Time required per household [Срок оценки: During the distribution period (1 week)]
• Cost per Guardian delivered [Срок оценки: during study preparation and completion (1 year)]
• Incidence of malaria-related visits to the CSI by children under 5 years of age [Срок оценки: 12 month after distribution]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Niger · 1 центр

• Program National de Santé Oculaire — Niamey

Публикации

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Идентификаторы

NCT: NCT07712263 · 23-39839-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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