A Phase 4 interventional study of Guardian™ long-lasting spatial emanators in Malaria Infection, sponsored by The Mentor Initiative. Not yet recruiting at 1 site in South Sudan. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The Mentor Initiative · Phase 4, Interventional, and Prevention
The overall aim of this study is to evaluate the feasibility, implementation, public health effectiveness, durability, acceptability and cost of delivering long-lasting spatial emanators at scale through United Nations High Commissioner for Refugees (UNHCR) humanitarian supply chains and distribution systems in northern South Sudan.
Primary objective:
To determine whether distribution of Guardian™ long-lasting spatial emanators reduces all-age malaria infection prevalence at 6 months in intervention populations compared with contemporaneous control populations during Phase 1 of the study.
Secondary objectives:
Tertiary and exploratory objectives:
Humanitarian emergencies increase malaria risk while fundamental logistical and biological constraints adversely affect the delivery and efficacy of conventional vector control tools. Long-lasting spatial emanators are lightweight, passive interventions potentially suited to strategic stockpiling and rapid deployment, but evidence on large-scale implementation and public health impact under emergency conditions remains limited. This study will evaluate the operational distribution and effectiveness of Guardian™, a World Health Organization recommended long-lasting transfluthrin spatial emanator, in northern South Sudan, to support its transition to a routine humanitarian vector control commodity.
This is a 26-month prospective, non-randomized, controlled, mixed-methods implementation-effectiveness evaluation study. The study will assess whether humanitarian delivery systems can achieve and sustain adequate household coverage, correct placement, continued use, acceptability, safety, and product durability, while evaluating malaria infection prevalence and human-vector contact.
The study will comprise two sequential operational phases, targeting 3 distinct beneficiary groups. Newly displaced refugees are recent arrivals living in reception, temporary, or transitional settings before or during settlement. Approximately 5,000 newly arrived refugees will be targeted for Guardian™ deployment in each study phase. Established camp residents are refugees living in Ajuong Thok and Pamir, where more stable settlement conditions support repeated monitoring and linkage with routine health services. Refugee-hosting communities and host-settled communities (former refugees) comprise the population included in the Yida host-community comparison and surrounding dispersed host communities. These settings provide information on delivery and use under different housing, access, and population conditions. Dispersed host communities will enter the evaluation during Phase 2.
Guardian™ will be delivered through existing humanitarian procurement, warehousing, transport, distribution, and community-engagement systems. UNHCR will coordinate in-country logistics and distribution. The MENTOR Initiative will support procurement and implementation and lead monitoring and evaluation with the University of Nevada, Las Vegas and national partners. Household intervention allocations will be determined by shelter volume according to the manufacturer's instructions. Distribution will be accompanied by education, communication and information on unpacking, placement, intended use, and reporting of concerns. Stock movements, distribution completeness, missed households, product damage, and implementation adaptations will be documented throughout the delivery pathway.
During Phase 1, Guardian™ will be distributed house-to-house in a designated intervention area within Yida and throughout Ajuong Thok refugee camp. A geographically separate area of Yida and Pamir refugee camp will serve as contemporaneous controls. Intervention allocation will be determined prospectively at the geographic area level without randomization. Existing malaria prevention, diagnosis, and treatment services will continue in all study populations. Two population-specific effectiveness comparisons will be evaluated separately: Yida intervention versus Yida control, and Ajuong Thok versus Pamir. Phase 1 monitoring will continue for 12 months after deployment.
Implementation monitoring will combine repeated cross-sectional household surveys with a nested longitudinal household cohort. During Phase 1, repeated cross-sectional surveys will sample 15 geographic clusters and 20 households per cluster in each of the two main intervention populations, providing approximately 300 households in Yida and 300 in Ajuong Thok per round. Six rounds will be conducted at 1-2 weeks and at 1, 3, 6, 9, and 12 months after distribution, generating approximately 3,600 household-round observations across the two populations. New random household samples will be selected at each round from updated sampling frames. The separate Phase 1 new-arrival population will contribute approximately 300 households per round at 1-2 weeks, 1 month, and 3 months, providing approximately 900 additional household-round observations.
The Phase 1 longitudinal implementation cohort will enroll 15 households per cluster within the same 15 clusters in each main intervention population, providing 225 households in Yida and 225 in Ajuong Thok (450 households overall). Allowing for approximately 20% loss to follow-up, around 360 households are expected to remain under observation through Phase 1. Repeated cross-sectional surveys will estimate population-level coverage, allocation adequacy, correct use, acceptability, and safety indicators. The longitudinal cohort will characterize trajectories of original-unit retention, placement, continued use, loss, damage, transfer, replacement, and discontinuation within the same households.
The primary effectiveness evaluation will assess all-age malaria infection prevalence 6 months after Phase 1 deployment using repeated cross-sectional household surveys. Surveys will be undertaken at baseline and at 3, 6 and 12 months post-distribution. The 6-month survey will provide the primary effectiveness assessment; the 3-month survey will assess intermediate changes, and the 12-month survey will measure persistence of impact across the operational lifespan of this intervention. Thirty-five fixed geographic sampling clusters will be selected in each of the four study areas and retained across survey rounds. New household and participant samples will be selected within these clusters, with up to two randomly selected eligible residents tested per household. Each area will contribute a target of 1,372 valid malaria rapid diagnostic test results per round, providing 5,488 results per round and 21,952 results across the four Phase 1 surveys. Participants with positive test results will receive anti-malarial treatment according to national guidelines.
For each Phase 1 population comparison, the primary analysis will estimate the intervention-to-control prevalence ratio at 6 months, adjusted for observed baseline malaria prevalence in the corresponding geographic sampling cluster and prespecified covariates: age, sex, shelter type, previous night insecticide-treated net use, and usual sleeping location. Modified Poisson generalized estimating equations (GEEs) will account for clustering, with small-sample corrections for statistical inference. A baseline-to-6-month ratio of prevalence ratios will provide a sensitivity analysis. The two population comparisons will be reported separately. Geographic sampling clusters are sampling units rather than independent intervention allocation units, and interpretation will account for potential residual geographic confounding.
Phase 1 entomological monitoring will include 60 fixed sentinel households in each of the four study areas, providing 240 households overall. Each household will contribute two paired indoor/outdoor baseline collection nights and one paired collection night per month for 6 months after deployment, during the main malaria transmission season. This provides 1,920 paired household-nights, equivalent to 3,840 indoor and outdoor collector nights. Human landing catches will be supplemented by household Prokopack aspiration collections of resting mosquitoes the following morning. Laboratory investigations will characterize vector species, Plasmodium infection, verterbrate blood meal sources, and molecular changes in transfluthrin response.
Indoor and outdoor female Anopheles landing counts will be analyzed separately using negative binomial mixed-effects models that account for repeated household collections and collection effort. Each analysis will combine the host-community and refugee-camp comparison strata to estimate a pooled baseline-to-post-deployment ratio of landing rate ratios. Multiplicity adjustment will be applied across the two key secondary entomological comparisons.
Progression to Phase 2 will depend on review of Phase 1 prespecified operational, implementation, safety, and monitoring criteria. Phase 2 will expand Guardian™ distribution to the remaining study populations, including former control areas and dispersed host communities, and replace units in previously treated populations. Follow-up will continue for 6 months after scale-up to universal coverage.
Phase 2 implementation monitoring will sample Yida, Ajuong Thok, Pamir, and dispersed host communities separately. Each population will contribute approximately 300 households per repeated cross-sectional survey, selected through 15 geographic clusters and 20 households per cluster. Surveys at 1-2 weeks and at 1, 3, and 6 months will provide 1,200 household observations per round and 4,800 household-round observations overall across the four populations. A nested longitudinal cohort will enroll 225 households per population, providing 900 households at enrollment. Approximately 720 households are expected to remain under observation at 6 months after allowing for 20% loss to follow-up.
Phase 2 malaria surveys will be undertaken during the pre-Phase 2 reference period and at 6 months following universal deployment. Yida and dispersed host communities will each contribute 1,372 valid rapid diagnostic test results per round. Ajuong Thok and Pamir will each contribute 686 results per round to a combined refugee-population analysis. This provides 4,116 results per round and 8,232 across the two Phase 2 surveys. Analyses will account for geographic sampling clusters, study setting, camp, and previous Phase 1 exposure, where separately identifiable. Because Phase 2 has no untreated contemporaneous control, changes will be interpreted as supportive pre/post associations.
Phase 2 entomological monitoring will include 60 fixed sentinel households in each of Yida, Ajuong Thok, Pamir, and dispersed host communities, providing 240 households overall. Two paired baseline collection nights and 6 monthly paired follow-up nights per household will provide 1,920 paired household-nights and 3,840 collector-nights. Analyses will assess changes in indoor and outdoor landing rates within participating populations following universal deployment.
Newly arrived refugees will contribute separate short-duration epidemiological and entomological assessments in each study phase. Malaria surveys at enrollment or Guardian™ receipt and approximately 3 months later will target 600 valid test results per round, providing 1,200 results per new arrival population in each phase. Approximately 320 households, sampled through 16 clusters and 20 households per cluster, will be approached at each round. Entomological monitoring will include 60 sentinel households per new arrival population. Where operationally feasible, two paired reference period collection nights will precede 3 monthly paired follow-up nights, providing 300 paired household nights and 600 collector nights per phase. These assessments will provide descriptive evidence on early changes following arrival, settlement, and deployment.
Focus groups, interviews, community feedback, field-team debriefs, and observations of distribution processes will explore acceptability, barriers to sustained intervention use, and opportunities to improve delivery across beneficiary groups. Product durability will be assessed through household observation and chemical analysis. Baseline quality control will use unused stock in each phase, followed by field unit retrievals at 3, 6, 9, and 12 months in Phase 1 and at 3 and 6 months in Phase 2. Retrieved units will be replaced one-for-one, with replacements documented separately from originally deployed units. Activity-based costing will assess the resources required for procurement, delivery, community engagement, monitoring, and maintenance of coverage.
Retrospective and prospective routine health facility data will provide additional information on malaria burden, testing, treatment, reporting completeness, and service disruptions. Population movement, seasonality, rainfall, access constraints, and other malaria interventions will be documented to support interpretation. Consent procedures will distinguish participation in research from access to humanitarian commodities and services. Human landing catch collectors will provide separate consent and receive training, malaria chemoprophylaxis, regular malaria testing, and prompt diagnosis and treatment.
Quantitative and qualitative findings will be integrated across beneficiary groups to assess effectiveness alongside implementation fidelity, safety, durability, acceptability, and cost. The evaluation will inform practical guidance on the delivery and potential scale-up of long-lasting spatial emanators in humanitarian settings.
1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 32,584 is above the median of 220 across 1,041 interventional studies indexed under Malaria.
Browse Malaria studies →The Mentor Initiative is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participation in research evaluation activities is voluntary and does not affect access to Guardian™, health care or any other humanitarian assistance.
Device: Guardian™ long-lasting spatial emanators
Arm Description: Guardian™ (SC Johnson \& Son, Racine, WI, USA) is a long-lasting spatial emanator. The active ingredient is transfluthrin (C15H12Cl2F4O2, 2.5 g/Guardian™, EPA Reg. number 432-1588). Each unit has a mean emanation rate of 4.7 mg/day, with 2 units installed per regular size room (12 m2/30 m3; 9.4 mg/day emanation per room). This intervention is designed to remain efficacious for 12-months upon opening.
Also known as: Spatial repellents
All-age malaria infection prevalence at 6 months following Phase 1 Guardian™ deployment
Percentage of randomly selected participants of all ages with a positive malaria rapid diagnostic test, irrespective of symptoms, calculated as the number with positive results divided by the number with valid results, multiplied by 100. Two separate Phase 1 comparisons will be conducted: Yida intervention versus Yida control, and Ajuong Thok intervention versus Pamir control. The effect measure will be the intervention-to-control prevalence ratio, adjusted for baseline malaria prevalence in the corresponding geographic sampling cluster and prespecified participant and household covariates.
Time frame: 6 months after Phase 1 Guardian™ deployment.
Indoor female Anopheles landing rate
Number of female Anopheles mosquitoes collected indoors by human landing catches divided by indoor collection effort, expressed as mosquitoes per person-hour. Phase 1 analyses will compare baseline-to-post-distribution changes between intervention and control populations, pooling the two population comparison strata. Phase 2 and newly arriving refugee analyses will assess changes from their respective reference periods.
Time frame: Baseline and monthly during months 1-6 after distribution in each phase; baseline and monthly during months 1-3 for newly arriving refugees.
Outdoor female Anopheles mosquito landing rate
Number of female Anopheles mosquitoes collected outdoors by human landing catches divided by outdoor collection effort, expressed as mosquitoes per person-hour. Phase 1 analyses will compare baseline-to-post-distribution changes between intervention and control populations, pooling the two population comparison strata. Phase 2 and newly arriving refugee analyses will assess changes from their respective reference periods.
Time frame: Baseline and monthly during months 1-6 after distribution in each phase; baseline and monthly during months 1-3 for newly arriving refugees.
Percentage of targeted households receiving Guardian™ within the planned distribution window
Number of targeted households documented as receiving Guardian™ within the prespecified distribution window divided by the total number of households targeted for that distribution, multiplied by 100. Receipt dates will be obtained from distribution registers and verified through household monitoring. Results will be reported by beneficiary group and implementation phase.
Time frame: At completion of each distribution round, up to 2 weeks after the start of distribution, in Phases 1 and 2
Percentage of targeted households receiving at least one Guardian™ unit
Percentage of sampled households in targeted intervention populations reporting receipt of at least one Guardian™ unit. Estimates will be obtained through repeated cross-sectional household surveys, supported by distribution records and direct observation where possible. Results will be reported separately for established camp residents, host communities and newly arriving refugees.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after distribution. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of recipient households receiving an adequate number of Guardian™ units for shelter volume
Number of recipient households receiving at least the number of Guardian™ units required for their measured shelter volume divided by the number of recipient households assessed, multiplied by 100. Required unit numbers will follow the manufacturer's dosing instructions, based on one unit per less than 15 cubic metres of shelter volume.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after distribution. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of household respondents correctly identifying Guardian™'s purpose and key use instructions
Percentage of interviewed adult household respondents who correctly identify Guardian™'s intended purpose of reducing mosquito exposure and describe at least two key use instructions. Instructions include unpacking/activation, appropriate placement, adequate unit numbers for shelter volume, continuous use, and safe handling or reporting procedures.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after distribution. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of recipient households with correctly positioned Guardian™ units
Percentage of assessed recipient households whose deployed Guardian™ units meet the manufacturer's placement instructions, determined through direct shelter observation using a standardized checklist. Placement will be assessed separately from whether the household received sufficient units for its shelter volume.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after distribution. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of originally issued Guardian™ units retained and in use
Number of originally issued Guardian™ units verified as remaining in use in the monitored household divided by the number originally issued to that household, multiplied by 100. Unit identifiers and repeated household observations will distinguish original units from replacements. Loss, transfer, removal, disposal and replacement will be recorded separately.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after receipt. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of household respondents reporting a perceived benefit from Guardian™ use
Percentage of interviewed household respondents reporting that Guardian™ use has provided a perceived benefit, such as reduced mosquito presence, biting or nuisance. Structured survey responses will be complemented by interviews and focus group discussions exploring the nature of perceived benefits.
Time frame: Phase 1: 1-2 weeks and 1, 3, 6, 9 and 12 months after receipt. Phase 2: 1-2 weeks and 1, 3 and 6 months. New arrivals: 1-2 weeks and 1 and 3 months in each phase.
Percentage of observed Guardian™ units remaining physically intact
Number of Guardian™ units observed to be physically intact divided by the number of units inspected, multiplied by 100. Field teams will document visible damage and the type of damage using a standardized observation checklist. Findings will be linked to product age, placement location, shelter characteristics and exposure conditions.
Time frame: Phase 1: 3, 6, 9 and 12 months after deployment. Phase 2: 3 and 6 months after deployment.
Residual transfluthrin content in retrieved Guardian™ units
Transfluthrin content in sampled Guardian™ units, measured by gas chromatography and expressed as mass of transfluthrin per unit. Unused units will provide baseline quality control measurements. Retrieved field units will be assessed by duration of deployment, beneficiary group and relevant exposure conditions. Residual content will also be expressed relative to baseline content.
Time frame: Phase 1: unused unit baseline and 3, 6, 9 and 12 months after deployment. Phase 2: unused unit baseline and 3 and 6 months after deployment.
Implementation cost per Guardian™ unit delivered
Total humanitarian implementation cost divided by the number of Guardian™ units delivered to households, expressed in US dollars per unit. Costs will include procurement, shipment, customs clearance, storage, transport, distribution, training, community engagement, supervision and routine implementation monitoring. Research-only costs will be identified separately. Estimates will be reported by implementation phase, beneficiary group and distribution modality.
Time frame: From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution.
Implementation cost per household receiving Guardian™
Total humanitarian implementation cost divided by the number of households receiving at least one Guardian™ unit, expressed in US dollars per household reached. Research-only costs will be identified separately. Estimates will be reported by implementation phase, beneficiary group and distribution modality.
Time frame: From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution.
Implementation cost per person living in a household with adequate Guardian™ coverage
Total humanitarian implementation cost divided by the estimated number of people living in households receiving adequate numbers of Guardian™ units for their shelter volume, expressed in US dollars per person. This operational coverage measure does not assume that every covered individual is protected from malaria infection. Estimates will be reported by implementation phase and beneficiary group.
Time frame: From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution.
Implementation cost per correctly protected person-month
Total humanitarian implementation cost divided by cumulative person-months in households with adequate Guardian™ dosing for shelter volume, correct placement, and retained units in use. Person-months will combine household occupancy with observed implementation status over time. Interpolation between monitoring visits and alternative assumptions will be examined in sensitivity analyses. Results will be expressed in US dollars per correctly protected person-month.
Time frame: From household receipt through 12 months in Phase 1, 6 months in Phase 2, and 3 months for newly arriving refugees in each phase.
Incremental implementation cost per malaria clinical case averted
Incremental humanitarian implementation cost divided by the estimated number of malaria clinical cases averted, expressed in US dollars per case averted. This exploratory analysis will be undertaken only where the effectiveness data support a defensible estimate of clinical cases averted. Assumptions and uncertainty in costs, coverage and effectiveness will be examined through sensitivity analyses.
Time frame: Effectiveness and cost observations through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution.
Plan to share: Yes — Summary findings from trial data will be published in peer reviewed publications and their supporting information. All other relevant de-identified participant data are available from the trial PIs upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be available upon publication of the main trial manuscript, following trial completion and will be available indefinitely.
Access criteria: Summary findings from trial IPD will be published in open-access, peer reviewed papers and their supporting information. Following trial completion, IPD will be available indefinitely, upon publication of the main trial manuscript. All other relevant de-identified IPD are available from the trial Principal Investigators upon reasonable request.
Start is estimated for Oct 2026; primary completion for Nov 2027, 13 months later.
Of 54 non-industry phase 4 interventional studies under Malaria, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's planned 13 months is below that.
Counting every sponsor, half of 56 studies reached it within 18 months; a quarter within 6 and three quarters within 29.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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