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Clinical Trial

Humanitarian Evaluation of Spatial Emanators for Malaria Control

NCT: NCT07886281 · NOT_YET_RECRUITING

NCT IDNCT07886281
StatusNOT_YET_RECRUITING
Start Date2026-10-26
Completion2028-11-30
SponsorThe Mentor Initiative (OTHER)
First posted
Last updated

Brief Summary

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: * Estimate the effect of Guardian™ on indoor and outdoor mosquito biting rate, including female Anopheles landing rates. * Evaluate the feasibility and fidelity of humanitarian delivery through UNHCR supply chains, including timeliness, household coverage, adequacy of units relative to shelter volume, unpacking, correct placement and retention. * Assess acceptability and safety, including user understanding, perceived benefit, barriers to use, product-related concerns and willingness to continue use or receive replacement units. * Assess product durability and performance through field observations of physical integrity and quantitative chemical analysis of retrieved units. * Describe changes in routine health facility malaria indicators and household-reported febrile illness as complementary measures of public health impact. Tertiary and exploratory objectives: * Estimate the cost and cost-efficiency of humanitarian delivery, including cost per unit delivered, household reached, person protected and correctly protected person-month, and estimate cost-effectiveness where supported by effectiveness data. * Examine whether coverage, dose adequacy, correct placement, retention, shelter characteristics, population movement, seasonality and other contextual factors explain heterogeneity in epidemiological or entomological effects. * Compare implementation performance and acceptability across different beneficiary groups (refugee camps, host communities and newly arriving displaced populations). * Integrate epidemiological, entomological, implementation, qualitative, durability and economic findings to inform transition of long-lasting spatial emanators toward routine use as a humanitarian vector control commodity and guide future UNHCR, Ministry of Health and WHO implementation and scale-up decisions.

Official Source

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