Integrating the Guardian Spatial Emanator Within AVENIR II

NCT07712263 | Not Yet Recruiting DMC

• 1 other identifier: 23-39839-1
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malaria

Keywords

transfluthrin; malaria; spatial emanator; implementation science; cluster randomized

Outcome Measures

Primary Outcomes (3)

• Proportion of eligible households that received spatial emanators

  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

  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

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

  12 months after distribution

Secondary Outcomes (5)

• 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

Study Arms (2)

Guardian Spatial Emanator

EXPERIMENTAL

Eligible households in CSI catchment areas assigned to the intervention will receive Guardian spatial emanators during integrated delivery with azithromycin mass drug administration.

Device: Spatial Emanator

No Guardian Spatial Emanator

NO INTERVENTION

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.

Interventions

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.

Guardian Spatial Emanator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Program National de Santé Oculaire

Niamey, Niger

Location

Related Publications (12)

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Related Links

• WHO guidelines for malaria

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Kieran S O'Brien, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea R Picariello, MPH

CONTACT

609-865-4532; andrea.picariello@ucsf.edu

Elodie J Lebas

CONTACT

elodie.lebas@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized, 1:1 assignment study in which Centre de Santé Intégré (CSI) are randomized to either integrated delivery of Guardian spatial emanators plus azithromycin mass drug administration or standard azithromycin mass drug administration without Guardian integration.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after publication of the outcomes and will be made available indefinitely.
• Access Criteria: Once made available, the data will be open access.

Locations

NI (1)