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NCT Number: NCT07712263

Integrating the Guardian Spatial Emanator Within AVENIR II

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spatial Emanator

Device

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

Primary outcomes

  1. Proportion of eligible households that received spatial emanators

    Time frame: 1 month after distribution

    Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.

  2. Acceptability of the integrated delivery

    Time frame: 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.

  3. Proportion of households with correct product placement

    Time frame: 12 months after distribution

    Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits

Secondary outcomes

  1. Proportion of households reached with messaging regarding the intervention

    Time frame: 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

  2. Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs

    Time frame: 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

  3. Time required per household

    Time frame: During the distribution period (1 week)

    Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.

  4. Cost per Guardian delivered

    Time frame: during study preparation and completion (1 year)

    Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention

  5. Incidence of malaria-related visits to the CSI by children under 5 years of age

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea R Picariello, MPH

CONTACT

[email protected]

609-865-4532

Elodie J Lebas

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Centre de Recherche Médicale et Sanitaire
  • Centre de recherche et interventions en santé publique (CRISP)
  • Le Programme National de Santé Oculaire
  • Ministère de la Santé Publique du Niger
  • S.C. Johnson & Son, Inc.

Registry information

Acronym: GUARD-AV

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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