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Integrating the Guardian Spatial Emanator Within AVENIR II (GUARD-AV)

20. juli 2026 oppdatert av: University of California, San Francisco

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

150000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Niamey, Niger
        • Program National de Santé Oculaire
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of eligible households that received spatial emanators
Tidsramme: 1 month after distribution
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
Tidsramme: 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.
1 month after distribution
Proportion of households with correct product placement
Tidsramme: 12 months after distribution
Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits
12 months after distribution

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of households reached with messaging regarding the intervention
Tidsramme: 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
During the distribution period (1 week)
Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs
Tidsramme: 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
During the distribution period (1 week)
Time required per household
Tidsramme: During the distribution period (1 week)
Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.
During the distribution period (1 week)
Cost per Guardian delivered
Tidsramme: during study preparation and completion (1 year)
Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention
during study preparation and completion (1 year)
Incidence of malaria-related visits to the CSI by children under 5 years of age
Tidsramme: 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)
12 month after distribution

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

14. juli 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data underlying outcomes publications will be made publicly available.

IPD-delingstidsramme

Data will be made available after publication of the outcomes and will be made available indefinitely.

Tilgangskriterier for IPD-deling

Once made available, the data will be open access.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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