Trial · NCT07886281
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-age malaria infection prevalence at 6 months following Phase 1 Guardian™ deployment | 6 months after 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. |
| Secondary | Indoor female Anopheles landing rate | Baseline and monthly during months 1-6 after distribution in each phase; baseline and monthly during months 1-3 for newly arriving refugees. | 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. |
| Secondary | Outdoor female Anopheles mosquito landing rate | Baseline and monthly during months 1-6 after distribution in each phase; baseline and monthly during months 1-3 for newly arriving refugees. | 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. |
| Other | Percentage of targeted households receiving Guardian™ within the planned distribution window | At completion of each distribution round, up to 2 weeks after the start of distribution, in Phases 1 and 2 | 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. |
| Other | Percentage of targeted households receiving at least one Guardian™ unit | 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 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. |
| Other | Percentage of recipient households receiving an adequate number of Guardian™ units for shelter volume | 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. | 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. |
| Other | Percentage of household respondents correctly identifying Guardian™'s purpose and key use instructions | 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 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. |
| Other | Percentage of recipient households with correctly positioned Guardian™ units | 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 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. |
| Other | Percentage of originally issued Guardian™ units retained and in use | 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. | 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. |
| Other | Percentage of household respondents reporting a perceived benefit from Guardian™ use | 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 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. |
| Other | Percentage of observed Guardian™ units remaining physically intact | Phase 1: 3, 6, 9 and 12 months after deployment. Phase 2: 3 and 6 months after deployment. | 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. |
| Other | Residual transfluthrin content in retrieved Guardian™ units | 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. | 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. |
| Other | Implementation cost per Guardian™ unit delivered | From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution. | 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. |
| Other | Implementation cost per household receiving Guardian™ | From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution. | 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. |
| Other | Implementation cost per person living in a household with adequate Guardian™ coverage | From procurement through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution. | 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. |
| Other | Implementation cost per correctly protected person-month | From household receipt through 12 months in Phase 1, 6 months in Phase 2, and 3 months for newly arriving refugees in each phase. | 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. |
| Other | Incremental implementation cost per malaria clinical case averted | Effectiveness and cost observations through 12 months after Phase 1 distribution and 6 months after Phase 2 distribution. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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