Malaria
Conditions
Keywords
Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
Brief summary
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
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.
Interventions
DEVICETransfluthrin - delivery by paid study personnel
Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel
DEVICETransfluthrin - delivery by voucher system
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.
DEVICETransfluthrin - delivery by village health teams
Passive emanator with formulated transfluthrin, village health teams will distribute SR products.
Sponsors
S.C. Johnson & Son, Inc.
Catholic Relief Services
Infectious Diseases Research Collaboration, Uganda
University of Notre Dame
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study design will be a prospective cluster Randomized Control Trial (cRCT)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of SR against malaria infection (both first-time and recurrent). | 12 months | Measured by rapid diagnostic tests in children aged between 6 months to 59 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of SR distribution. | 12 months | Measure cost of SR implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness. |
| Adverse Events and Serious Adverse Events. | 12 months | 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. |
Countries
Uganda
Outcome results
None listed