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Vector Control Strategies for Malaria
N/A
Waitlist Available
Led By Guiyun Yan, Ph.D.
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up vector density will be monitored for up to 60 months
Summary
This trial is testing different vector control methods to find the best way to reduce malaria incidence and infection in Kenya.
Who is the study for?
This trial is for households in Kenya with residents willing to consent to participate. It includes adults and minors who agree to the intervention and survey, as well as those present during health facility visits or active case detection efforts. Households are excluded if no adult is home after multiple visits or if vacant.
What is being tested?
The study tests different malaria control methods like microbial larvicides, indoor spraying, and various insecticidal nets. Using a SMART design, it aims to find the best strategy based on local transmission risks and vector ecology by comparing their effectiveness in reducing malaria.
What are the potential side effects?
While specific side effects are not detailed here, interventions may include typical reactions to insecticides such as skin irritation or respiratory issues among sensitive individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ vector density will be monitored for up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vector density will be monitored for up to 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annual clinical malaria incidence rate
Secondary study objectives
Malaria infection prevalence
Malaria transmission intensity
Malaria vector density
Trial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Piperonyl butoxide-treated LLINExperimental Treatment1 Intervention
All participants will received piperonyl butoxide-treated LLINs (PBO-LLINs) at Stage 1 and Stage 2 interventions provided that PBO-LLINs are effective at Stage 1 interventions. Each household will be provided on PBO-LLIN per two people with appropriate eduction.
PBO-LLIN: Olyset Plus, containing 2% permethrin and 1% PBO.
Group II: PBO-LLIN plus larval source managementExperimental Treatment2 Interventions
All participants will received piperonyl butoxide-treated LLINs (PBO-LLINs) at Stage 1. However, if Stage 1 intervention is not effective, half of them will randomized to receive PBO-LLINs plus larval source management (LSM) at Stage 2. LSM will be implemented in selected clusters, including chemical methods by larviciding of semi-permanent and permanent habitats, per the National Malaria Strategic Plan of Kenya. The investigators will use the long-lasting microbial larvicides manufactured by Central Life Sciences. Semi-permanent and permanent habitats will be treated with FourStar® 180-day Briquets using the recommended dosage of 100 ft2 water surface per briquet.
Group III: PBO-LLIN plus enhanced methodsExperimental Treatment1 Intervention
All participants will received piperonyl butoxide-treated LLINs (PBO-LLINs) at Stage 1, however, Stage 1 intervention is not effective. All participants will received PBO-LLINs plus an enhanced intervention at Stage 2, i.e., annual IRS using Kenya Government recommended insecticides.
Group IV: LLIN+IRS twice a yearExperimental Treatment3 Interventions
All participants will received regular LLINs plus IRS at Stage 1, provided that LLIN+IRS is not effective. IRS will be increased to twice a year.
Group V: LLIN+IRS plus enhanced methodExperimental Treatment2 Interventions
All participants will received regular LLINs plus IRS at Stage 1, provided that LLIN+IRS is not effective. Enhanced method will be added on these clusters at Stage 2 interventions.The enhanced intervention is the regular IRS plus IRS treating animal sheds and other outdoor structures.
Group VI: LLIN plus indoor residual sprayingExperimental Treatment2 Interventions
All participants will received regular LLINs plus indoor residual spraying (IRS) (LLIN+IRS) at Stage 1 and Stage 2 interventions provided that LLIN+IRS is effective at Stage 1 interventions. For LLIN+IRS clusters, each dwelling's interior walls and ceilings will be sprayed with micro-encapsulated pirimiphos-methyl (Actellic 300CS) at the recommended dosage of 1g/m² and at the government-recommended frequency. If Kenya government switch the IRS insecticide, the investigators will use the same insecticide as the government recommended.
Group VII: Regular long-lasting insecticidal netsPlacebo Group1 Intervention
All participants will have LLIN coverage through routine MoH distribution of long-lasting insecticidal nets (LLINs), no other interventions will be applied. Regular LLIN: Olyset nets containing 2% permethrin or PermaNet 2.0 containing 1.8 and 1.4 g/kg, respectively, for 75 and 100 denier yarn.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,810,206 Total Patients Enrolled
Guiyun Yan, Ph.D.Principal InvestigatorUniversity of California at Irvine
1 Previous Clinical Trials
240,000 Total Patients Enrolled
John Githure, Ph.D.Study DirectorTom-Mboya University, Kenya
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but that criterion seems incomplete. Could you please provide more details or context?
Research Study Groups:
This trial has the following groups:- Group 1: PBO-LLIN plus larval source management
- Group 2: LLIN+IRS twice a year
- Group 3: LLIN+IRS plus enhanced method
- Group 4: Regular long-lasting insecticidal nets
- Group 5: LLIN plus indoor residual spraying
- Group 6: PBO-LLIN plus enhanced methods
- Group 7: Piperonyl butoxide-treated LLIN
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.