MalariaGUARD-AVNCT07712263
Integrating the Guardian Spatial Emanator Within AVENIR II
A study testing Spatial Emanator in people with Malaria, run by University of California, San Francisco at 1 site in Niger.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Spatial Emanator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150,000 participants
- Where
- 1 siteNiger
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elodie J Lebas contact
Niger1 site
Program National de Santé Oculaire
Niamey
Almou Ibrahim, MD, +227 20 75 29 06, idralmou@yahoo.com
About this study
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
Read the detailed description
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.
- Conditions
- Malaria
- Being tested
- Spatial Emanator
- Keywords
- transfluthrin, malaria, spatial emanator, implementation science, cluster randomized
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial EmanatorDevice
Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12 months after distribution
Secondary outcomes (5)
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
Measured: During the distribution period (1 week)
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
Measured: During the distribution period (1 week)
Time required per household
Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.
Measured: During the distribution period (1 week)
Cost per Guardian delivered
Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention
Measured: during study preparation and completion (1 year)
Incidence of malaria-related visits to the CSI by children under 5 years of age
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)
Measured: 12 month after distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche Médicale et Sanitaire, Bill and Melinda Gates Foundation, Le Programme National de Santé Oculaire, Centre de recherche et interventions en santé publique (CRISP), Ministère de la Santé Publique du Niger, S.C. Johnson & Son, Inc.
- Responsible party
- Sponsor
- Investigators
- Kieran S O'Brien, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712263
- Sponsor's protocol ID
- 23-39839-1
- Acronym
- GUARD-AV
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data underlying outcomes publications will be made publicly available.
Publications
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.
PubMed 30984733Sekhon 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.
PubMed 28126032Glasgow 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.
PubMed 10474547Arzika 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.
PubMed 40824641Ochomo 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.
PubMed 39709979Morrison 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.
PubMed 35737833Syafruddin 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.
PubMed 32431275Chen 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.
PubMed 40866281O'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.
PubMed 39167806Oldenburg 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.
PubMed 38349371Keenan 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.
PubMed 29694816Sharrow 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.
PubMed 35063111