Evaluation of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence

NCT02392832 | Completed

• 1 other identifier: R01A1050243 [HS# 2008-6148]
• Study Type: interventional
• Target: 240,000
• Locations: 1 country
• Sites: 1

Brief Summary

In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. However, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of ITN and IRS because the current indoor-based interventions do not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The central objective of this study is to determine the efficacy and cost-effectiveness of EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western Kenya highlands.

Conditions

Malaria

Keywords

long-lasting microbial larvicide; intervention; cluster randomised controlled trial; Anopheles mosquito

Outcome Measures

Primary Outcomes (1)

• Changes in clinical malaria incidence rate

  Human population for each site stratified into three age groups, under 5 years, 6-15 years and \>15 years, will be ascertained from our existing demographic database. Age group level aggregate morbidity data with number of clinical malaria cases without any identifiers will be obtained from local hospitals and clinics where the study residents seek treatment. This data is reported to the Ministry of Health of Kenya and hence, is publicly available.

  baseline and 4 months following the interventions

Secondary Outcomes (2)

• Changes in vector abundance

  baseline and 4 months following the interventions

• EIR

  baseline and 4 months following the interventions

Study Arms (2)

Intervention arm

EXPERIMENTAL

Fourstar® granule formulation, 90day and 180 day briquettes Bti/Bs in larval habitats of malaria vectors.

Biological: Fourstar® granule, 90 day and 180 day briquettes Bti/Bs

Control arm

NO INTERVENTION

No larvicide application.

Interventions

Fourstar® granule, 90 day and 180 day briquettes Bti/Bs BIOLOGICAL

In 2015: Two sites each in Kakamega and Vihiga counties in western Kenya will be randomly selected and treated with larvicides (intervention) and the other two sites will serve as control (no-intervention). Temporary habitats will be treated with FourStar® controlled release granule formulation, semi-permanent habitats will be treated with 90 day briquettes, and permanent habitats with 180 day briquettes. No retreatment. Starts from 2016, a total of 34 clusters in the two study sites will be assigned to treatment or control by a block randomization method. The Bti treatment will be the same as in 2015. The retreatment interval will be 4-5 months. After the third treatment, no treatment will be performed for the next 8 months. After this, a cross over will be performed. Previous control sites will receive 3 rounds of the same LLML treatment at appropriate time intervals and previous treatment sites will not receive any LLMLs.

Intervention arm

Eligibility Criteria

• Age: 7 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All clinical malaria cases from participated local hospitals and clinics.

You may not qualify if:

• Infants younger than 6 months.

Sponsors & Collaborators

• University of California, Irvine: lead
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, 1578-40100, Kenya

Location

Related Publications (1)

• Zhou G, Wiseman V, Atieli HE, Lee MC, Githeko AK, Yan G. The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial. Trials. 2016 Aug 25;17(1):423. doi: 10.1186/s13063-016-1545-4.

  PMID: 27558161 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Guiyun Yan, Ph.D.

  University of California at Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Will be available by June 30, 2020
• Access Criteria: Available to public

Locations

KE (1)