Spatial Repellents for Malaria Control

Study Overview
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Brief Summary
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The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.

Detailed Description
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Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria and Aedes-borne viruses but their effectiveness in reducing mosquito borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito borne diseases in contexts where typical vectors control strategies, such as Insecticide-Treated Nets (ITNs) and indoor residual spray (IRS), are inaccessible or underutilized such as among displaced peoples or in emergency relief settings. To address this knowledge gap, the Bidibidi refugee settlement in the Yumbe District of North West Uganda was selected as the study site to estimate the impact of the SR on malaria related outcomes under operational use conditions given ongoing humanitarian relief efforts. Children will be enrolled in 3 separate cohorts to establish effectiveness of SRs in reducing malaria infection in distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and village health team (VHT) channel. Cohorts will be followed twice a month (approximately every 15 days) during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (RDT) (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using an SR in an area with high, year-round transmission of malaria.

Official Title
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Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda

Conditions
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Malaria

Intervention / Treatment
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* Device: Transfluthrin - delivery by paid study personnel
* Device: Transfluthrin - delivery by voucher system
* Device: Transfluthrin - delivery by village health teams


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ≥ 6 months to ≤ 59 months Children ≥ 6 months to ≤ 59 months with Hb > 7g/dL and no other serious illness Sleeps in cluster (i.e. study area) ≥ 90% of nights during any given month Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial Provision of informed consent form (ICF) signed by the parent(s) or guardian Exclusion Criteria: Children < 6 months and > 59 months Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation Sleeps in cluster (i.e. study area) < 90% of nights during any given month Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial No provision of ICF signed by the parent(s) or guardian

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design will be a prospective cluster Randomized Control Trial (cRCT)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study personnel distribution channel<br>SR product will be delivered by paid study personnel. | Device: Transfluthrin - delivery by paid study personnel<br>* Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel<br>|
| Experimental: Voucher distribution channel<br>Voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household. | Device: Transfluthrin - delivery by voucher system<br>* Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.<br>|
| Experimental: Village health team distribution channel<br>Village health teams will distribute SR products. | Device: Transfluthrin - delivery by village health teams<br>* Passive emanator with formulated transfluthrin, village health teams will distribute SR products.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of SR against malaria infection (both first-time and recurrent). | Measured by rapid diagnostic tests in children aged between 6 months to 59 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of SR distribution. | Measure cost of SR implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness. | 12 months | 
| Adverse Events and Serious Adverse Events. | Measured by solicited and unsolicited reports during the intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events and Serious Adverse Eventss across clusters among enrolled subjects will be summarized by distribution channel arm. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence