Trial · NCT07912528
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness of Guardian Spatial Emanator | 12 months | Time to first Plasmodium spp. infection detected by PCR at monthly follow-up visits or symptomatic ad-hoc visit between follow-ups over the 12-month intervention period in cohort participants from the core of the clusters. |
| Secondary | Effectiveness of Guardian Spatial Emanator | 12 months | Time to first PCR-confirmed P. falciparum infection over the 12 months of follow-up. Time to first PCR-confirmed P. vivax infection over the 12 months of follow-up. |
| Secondary | Effectiveness of Guardian Spatial Emanator | 6 months | Time to first PCR-confirmed Plasmodium spp infection over the first 6 months of follow-up. Time to first PCR-confirmed P. falciparum infection over the first 6 months of follow-up. Time to first PCR-confirmed P. vivax infection over the first 6 months of follow-up. |
| Secondary | Effectiveness of Guardian Spatial Emanator | 12 months | Incidence of PCR-confirmed Plasmodium spp infections (first-time \& recurrent together) in first 6m \& full 12m. Incidence of PCR-confirmed Pf infections (first-time \& recurrent together) in first 6m \& full 12m. Incidence of PCR-confirmed Pv infections (first-time \& recurrent together) in first 6m \& full 12m Incidence of clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of Pf clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of Pv clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of new Pf blood stage infections (molecular force of blood-stage infection - Pf molFOB) in first 6m \& full 12m Incidence of new Pv blood stage infections (molecular force of blood-stage infection - Pv molFOB) in first 6m \& full 12m Incidence of new blood stage infections (molecular force of blood-stage infection for Pf and Pv molFOB combined) in first 6m \& full 12m |
| Secondary | Difference between indoor and outdoor arms | 12 months | Time to first Plasmodium spp. infection detected by PCR at monthly follow-up or symptomatic ad-hoc visit between follow-ups visits over the 12-month intervention period in cohort participants from the core of the clusters. |
| Secondary | Sensitivity of the estimates for epidemiological outcomes | 12 months | Spillover-adjusted estimates of intervention effectiveness for epidemiological endpoints, incorporating data from cluster buffer zone participants. |
| Secondary | Anopheles species composition | 12 months | Anopheles species composition in a subset of clusters, in the pre-deployment baseline period and at the end of the intervention. |
| Secondary | Presence of insecticide resistance mutations | 12 months | Prevalence of insecticide resistance markers in a subset of clusters in the pre-deployment baseline period and at the end of the intervention. |
| Secondary | Acceptability of spatial emanators | 12 months | Qualitative outcomes from Photovoice methodology, and associated focus group discussions with community members, followed by thematic analysis of drivers of behaviour change, barriers and enablers of spatial emanator acceptance and consistent use. |
| Secondary | Feasibility of spatial emanators | 12 months | Qualitative outcomes from key informant interviews with key study staff and health system stakeholders at district, provincial, and national level followed by descriptive summary of barriers and enablers to distribution, implementation \& scale-up. |
| Secondary | Cost effectiveness of Guardian spatial emanators | 12 months | The costs of deploying spatial emanators (either indoor or outdoor) and the incremental cost-effectiveness ratios when compared with current practice. |
| Secondary | Self-reported adverse events | 12 months | Incidence of self-reported adverse events (AEs) and/or serious adverse events (SAEs) assessed as possibly or likely related to Guardian spatial emanators among cohort participants (through monthly follow-up) and wider community through passive surveillance. |
| Secondary | Coverage, attrition and re-location of spatial emanators | 12 months | Proportion of households with emanators in place at scheduled monitoring visits, the attrition rate per cluster per scheduled monitoring visit period, timing of redistribution events recorded per cluster. |
| Secondary | Transfluthrin quantity, installation environment and bioefficacy | 12 months | Mass percent transfluthrin retained in the spatial emanators related to installation environment and bioefficacy measure/s (e.g., knock down and mortality of colony mosquitoes exposed to spatial emanators). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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