Skip to content

Reducing the Burden of Malaria by Targeting Hotspots of Malaria Transmission

Reducing the Burden of Malaria by Targeting Hotspots of Transmission and Improving Malaria Control Measures in the Highlands of Western Kenya: Simultaneous Rollout of Four Malaria Control Interventions and Evaluation by Cross-sectional Surveys

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01575613
Acronym
REDHOT
Enrollment
17506
Registered
2012-04-11
Start date
2012-04-30
Completion date
2012-11-30
Last updated
2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

malaria, heterogeneity, transmission, elimination

Brief summary

In this study, the investigators propose to determine the value of rolling out four targeted malaria control efforts in reducing overall malaria transmission. These targeted control efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In addition, larviciding will be employed to target malaria vectors, also those that are less susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the human infectious reservoir will be reduced in hotspots of malaria transmission by treating parasite carriers and their household members with the current first-line antimalarial drug. The impact of these targeted interventions on overall transmission intensity will be assessed in the context of currently ongoing malaria control activities in a plausibility study. Hotspots of malaria transmission are defined in an area of 100km2 and randomized to receive hotspot targeted interventions and compared with their baseline and with control clusters where the routine (untargeted) malaria control activities continue. The interventions will be evaluated based on changes in parasite prevalence measured in community surveys inside and outside hotspots of malaria transmission. Parasite prevalence will be compared before and after the intervention in intervention clusters and between intervention and control clusters. In addition to malaria surveys in the human population, an entomological evaluation will take place where the densities of mosquito larvae and adult mosquitoes are monitored longitudinally.

Detailed description

DEFINITIONS This study uses a plausibility design to determine the plausible impact of hotspot-targeted interventions on overall malaria transmission. Hotspots will be detected in the 100km2 study area. Hotspots are defined as areas with a level of transmission intensity that exceeds that in the surrounding area; indicated by a higher sero-conversion rate and/or age-adjusted density of malaria-specific antibodies. Clusters for the intervention are defined as a hotspot and the area surrounding this hotspot in each direction up to 500 meters. INTERVENTION Half of the clusters will be randomized to hotspot-targeted interventions, while the other half will serve as control. The plausible impact of hotspot targeted interventions will be evaluated by comparing malaria indices in intervention clusters with their baseline and with control clusters. In each phase four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT). EVALUATION The primary outcome will be parasite prevalence in evaluation zones (i.e. the area surrounding malaria hotspots) of targeted and untargeted clusters. In addition, parasite prevalence will be determined inside hotspots of malaria transmission and in evaluation zones in relation to distance to the hotspot boundary. For this, community surveys are planned prior to the intervention and at two time-points after the intervention. An entomological evaluation will take place concurrently in which mosquito breeding sites are monitored for productivity and mosquitoes will be sampled indoors and outdoors. Malaria morbidity is assessed by passive case detection.

Interventions

Focal screening and treatment in all households in malaria hotspots prior to the peak transmission season. Screening of a sentinel age group by rapid diagnostic tests; all parasitaemic individuals and household members of parasitaemic individuals will be treated.

BIOLOGICALBacillus thuringiensis

Treatment of all waterbodies within hotspots with Bti or Bs on weekly basis

BIOLOGICALLong lasting insecticide treated net (LLINs)

Distribution of LLINs in all households in malaria hotspots; instruction about correct use.

BIOLOGICALIndoor Residual Spraying (IRS)

6-monthly IRS with deltamethrin in all households malaria hotspots.

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
International Centre of Insect Physiology and Ecology (ICIPE)
CollaboratorOTHER
Division of Malaria Control, Ministry of Health, Nairobi, Kenya
CollaboratorUNKNOWN
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

Exclusion criteria

* For LLINs, IRS and larviciding there are no

Design outcomes

Primary

MeasureTime frameDescription
Parasite prevalence in the evaluation zone surrounding malaria hotspots3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)Parasite prevalence, determined by PCR, in the evaluation zone surrounding hotspots in intervention and control clusters

Secondary

MeasureTime frameDescription
Parasite prevalence in the evaluation zone as function of distance to the hotspot boundary3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)Parasite prevalence, determined by PCR, in relation to distance to the boundary of malaria hotspots in intervention and control clusters
Anopheles mosquito densitydetermined during fortnightly trapping, starting at enrolment and continuing until up to 210 days after enrolmentIndoor and outdoor anopheles mosquito density inside and outside hotspots of malaria transmission in intervention and control clusters
Parasite prevalence inside malaria hotspots3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)Parasite prevalence, determined by PCR, inside hotspot of malaria transmission in intervention and control clusters
Safety and acceptability of interventionsat a single cross-sectional survey 15-45 days after enrolmentSide effects of FSAT, LLINs and IRS in targeted households
Mosquito breeding site productivitydetermined on a weekly basis for a period of up to 210 days after enrolmentThe presence and density of anopheles larvae in mosquito breeding sites in malaria hotspots in intervention and control clusters
Passive case detectiondetermined continuously for a period of up to 210 days after enrolmentNumber of malaria cases reporting at health facilities, coming from intervention and control clusters

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026