- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07712263
Integrating the Guardian Spatial Emanator Within AVENIR II (GUARD-AV)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Andrea R Picariello, MPH
- Número de teléfono: 609-865-4532
- Correo electrónico: andrea.picariello@ucsf.edu
Copia de seguridad de contactos de estudio
- Nombre: Elodie J Lebas
- Correo electrónico: elodie.lebas@ucsf.edu
Ubicaciones de estudio
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Niamey, Níger
- Program National de Santé Oculaire
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Contacto:
- Almou Ibrahim, MD
- Número de teléfono: +227 20 75 29 06
- Correo electrónico: idralmou@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of eligible households that received spatial emanators
Periodo de tiempo: 1 month after distribution
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Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.
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1 month after distribution
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Acceptability of the integrated delivery
Periodo de tiempo: 1 month after distribution
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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.
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1 month after distribution
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Proportion of households with correct product placement
Periodo de tiempo: 12 months after distribution
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Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits
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12 months after distribution
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of households reached with messaging regarding the intervention
Periodo de tiempo: During the distribution period (1 week)
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Proportion of households in participating CSI catchment areas that were reached with program messaging about Guardian spatial emanators during the distribution period
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During the distribution period (1 week)
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Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs
Periodo de tiempo: During the distribution period (1 week)
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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
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During the distribution period (1 week)
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Time required per household
Periodo de tiempo: During the distribution period (1 week)
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Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.
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During the distribution period (1 week)
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Cost per Guardian delivered
Periodo de tiempo: during study preparation and completion (1 year)
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Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention
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during study preparation and completion (1 year)
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Incidence of malaria-related visits to the CSI by children under 5 years of age
Periodo de tiempo: 12 month after distribution
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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)
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12 month after distribution
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kieran S O'Brien, PhD, University of California, San Francisco
Publicaciones y enlaces útiles
Publicaciones Generales
- Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
- Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
- Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
- Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.
- Oldenburg CE, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Zakane A, Coulibaly B, Bagagnan C, Hu H, O'Brien KS, Nyatigo F, Keenan JD, Doan T, Porco TC, Arnold BF, Lebas E, Sie A, Lietman TM. Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial. JAMA. 2024 Feb 13;331(6):482-490. doi: 10.1001/jama.2023.27393.
- Morrison AC, Reiner RC Jr, Elson WH, Astete H, Guevara C, Del Aguila C, Bazan I, Siles C, Barrera P, Kawiecki AB, Barker CM, Vasquez GM, Escobedo-Vargas K, Flores-Mendoza C, Huaman AA, Leguia M, Silva ME, Jenkins SA, Campbell WR, Abente EJ, Hontz RD, Paz-Soldan VA, Grieco JP, Lobo NF, Scott TW, Achee NL. Efficacy of a spatial repellent for control of Aedes-borne virus transmission: A cluster-randomized trial in Iquitos, Peru. Proc Natl Acad Sci U S A. 2022 Jun 28;119(26):e2118283119. doi: 10.1073/pnas.2118283119. Epub 2022 Jun 23.
- Sharrow D, Hug L, You D, Alkema L, Black R, Cousens S, Croft T, Gaigbe-Togbe V, Gerland P, Guillot M, Hill K, Masquelier B, Mathers C, Pedersen J, Strong KL, Suzuki E, Wakefield J, Walker N; UN Inter-agency Group for Child Mortality Estimation and its Technical Advisory Group. Global, regional, and national trends in under-5 mortality between 1990 and 2019 with scenario-based projections until 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet Glob Health. 2022 Feb;10(2):e195-e206. doi: 10.1016/S2214-109X(21)00515-5.
- Arzika AM, Abdou A, Maliki R, Lebas E, Cook C, Vanderschelden B, O'Brien KS, Cotter SY, Varnado NE, Callahan EK, Bailey RL, West SK, Rosenthal PJ, Porco TC, Lietman TM, Keenan JD; MORDOR-Niger Study Group. Biannual Mass Azithromycin Distributions for Preschool Children and Malaria Parasitemia: A Secondary Analysis of the MORDOR Cluster Randomized Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2527148. doi: 10.1001/jamanetworkopen.2025.27148.
- Ochomo EO, Gimnig JE, Awori Q, Abong'o B, Oria P, Ashitiba NK, Polo B, Moshi V, Otanga H, Adung'o F, Ouma EA, Outa S, Ramaita E, Levine R, Odongo W, Harvey SA, Monroe A, Hudson A, Sandberg B, Hendrickson J, Zhao X, Zhou R, Liu F, Achee NL, Grieco JP. Effect of a spatial repellent on malaria incidence in an area of western Kenya characterised by high malaria transmission, insecticide resistance, and universal coverage of insecticide treated nets (part of the AEGIS Consortium): a cluster-randomised, controlled trial. Lancet. 2025 Jan 11;405(10473):147-156. doi: 10.1016/S0140-6736(24)02253-0. Epub 2024 Dec 19.
- Syafruddin D, Asih PBS, Rozi IE, Permana DH, Nur Hidayati AP, Syahrani L, Zubaidah S, Sidik D, Bangs MJ, Bogh C, Liu F, Eugenio EC, Hendrickson J, Burton T, Baird JK, Collins F, Grieco JP, Lobo NF, Achee NL. Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Jul;103(1):344-358. doi: 10.4269/ajtmh.19-0554. Epub 2020 May 14.
- Chen I, Miller SL, Msellemu D, Lugenge AG, Swai JK, Achee N, Andres M, Bibbs CS, Chareonviriyaphap T, Charlwood JD, Devine G, Elman N, Fillinger U, Flores-Mendoza C, Gibson S, Govella N, Gowelo S, Horstmann S, Kawada H, Kline D, Lloyd A, Lobo NF, Maia MF, Mmbando A, Moreno-Gomez M, Morrison AC, Mponzi W, Mwanga EP, Njoroge M, Ogoma SB, Okumu FO, Opiyo M, Oumbouke WA, Paliga J, Pongsiri A, Ponlawat A, Saeaung M, Salazar F, Sangoro O, Stevenson JC, Sukkanon C, Syafruddin D, Tambwe MM, Tangena JA, Vajda EA, Vazquez-Prokopec G, Wagman JM, Yan C, Allen IE, Moore SJ. Volatile pyrethroid spatial repellents for preventing mosquito bites: a systematic review and meta-analysis. EBioMedicine. 2025 Sep;119:105891. doi: 10.1016/j.ebiom.2025.105891. Epub 2025 Aug 26.
- O'Brien KS, Arzika AM, Amza A, Maliki R, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Lebas E, Peterson B, Liu Z, Le V, Colby E, Doan T, Keenan JD, Oldenburg CE, Porco TC, Arnold BF, Lietman TM; AVENIR study group. Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial. N Engl J Med. 2024 Aug 22;391(8):699-709. doi: 10.1056/NEJMoa2312093.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23-39839-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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