Health Trials

Integrating the Guardian Spatial Emanator Within AVENIR II

ConditionMalaria
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150,000 Participants
are divided into 2 treatment groups
Group A: Guardian Spatial EmanatorExperimental treatment 1 intervention
Group B: No Guardian Spatial EmanatorNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month after distribution
2

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.

Time frame
1 month after distribution
3

Proportion of households with correct product placement

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

Time frame
12 months after distribution

Secondary outcomes

1

Proportion of households reached with messaging regarding the intervention

Proportion of households in participating CSI catchment areas that were reached with program messaging about Guardian spatial emanators during the distribution period

Time frame
During the distribution period (1 week)
2

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

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

Time frame
During the distribution period (1 week)
3

Time required per household

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

Time frame
During the distribution period (1 week)
4

Cost per Guardian delivered

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

Time frame
during study preparation and completion (1 year)

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: