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Reducing the Burden of Malaria by Targeting Hotspots of Malaria Transmission (REDHOT)

R

Radboud University Medical Center

Status

Completed

Conditions

Malaria

Treatments

Biological: Long lasting insecticide treated net (LLINs)
Drug: Artemether-lumefantrine combination
Biological: Bacillus thuringiensis
Biological: Indoor Residual Spraying (IRS)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01575613
REDHOT_OPP1024438

Details and patient eligibility

About

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.

Full 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.

Enrollment

17,506 patients

Sex

All

Ages

6+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

  • For LLINs, IRS and larviciding there are no exclusion criteria
  • Pregnant women and children < 6 months of age are excluded from FSAT

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17,506 participants in 2 patient groups

Hotspot Targeting
Experimental group
Description:
Four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination of IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT)campaign.
Treatment:
Biological: Bacillus thuringiensis
Biological: Indoor Residual Spraying (IRS)
Biological: Long lasting insecticide treated net (LLINs)
Drug: Artemether-lumefantrine combination
Control
No Intervention group
Description:
Standard of care as determined by the Division of Malaria Control of the Kenyan Ministry of Health

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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