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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene & Tropical Medicine, London, UK
Kenya Medical Research Institute, Kisumu, Kenya
International Centre of Insect Physiology and Ecology, Mbita, Kenya
Division of Malaria Control, Ministry of Health, Nairobi, Kenya
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01575613
First received: March 19, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Parasite prevalence in the evaluation zone surrounding malaria hotspots [ Time Frame: 3 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) ] [ Designated as safety issue: No ]
    Parasite prevalence, determined by PCR, in the evaluation zone surrounding hotspots in intervention and control clusters


Secondary Outcome Measures:
  • Parasite prevalence inside malaria hotspots [ Time Frame: 3 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) ] [ Designated as safety issue: No ]
    Parasite prevalence, determined by PCR, inside hotspot of malaria transmission in intervention and control clusters

  • Parasite prevalence in the evaluation zone as function of distance to the hotspot boundary [ Time Frame: 3 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) ] [ Designated as safety issue: No ]
    Parasite prevalence, determined by PCR, in relation to distance to the boundary of malaria hotspots in intervention and control clusters

  • Anopheles mosquito density [ Time Frame: determined during fortnightly trapping, starting at enrolment and continuing until up to 210 days after enrolment ] [ Designated as safety issue: No ]
    Indoor and outdoor anopheles mosquito density inside and outside hotspots of malaria transmission in intervention and control clusters

  • Passive case detection [ Time Frame: determined continuously for a period of up to 210 days after enrolment ] [ Designated as safety issue: No ]
    Number of malaria cases reporting at health facilities, coming from intervention and control clusters

  • Safety and acceptability of interventions [ Time Frame: at a single cross-sectional survey 15-45 days after enrolment ] [ Designated as safety issue: Yes ]
    Side effects of FSAT, LLINs and IRS in targeted households

  • Mosquito breeding site productivity [ Time Frame: determined on a weekly basis for a period of up to 210 days after enrolment ] [ Designated as safety issue: No ]
    The presence and density of anopheles larvae in mosquito breeding sites in malaria hotspots in intervention and control clusters


Enrollment: 17506
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hotspot Targeting
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.
Drug: Artemether-lumefantrine combination
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.
Biological: Bacillus thuringiensis
Treatment of all waterbodies within hotspots with Bti or Bs on weekly basis
Biological: Long lasting insecticide treated net (LLINs)
Distribution of LLINs in all households in malaria hotspots; instruction about correct use.
Biological: Indoor Residual Spraying (IRS)
6-monthly IRS with deltamethrin in all households malaria hotspots.
No Intervention: Control
Standard of care as determined by the Division of Malaria Control of the Kenyan Ministry of Health

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575613

Locations
Kenya
Rachuonyo District, Kenya
Sponsors and Collaborators
Radboud University
London School of Hygiene & Tropical Medicine, London, UK
Kenya Medical Research Institute, Kisumu, Kenya
International Centre of Insect Physiology and Ecology, Mbita, Kenya
Division of Malaria Control, Ministry of Health, Nairobi, Kenya
Investigators
Principal Investigator: Teun Bousema, PhD Radboud University
Principal Investigator: Jon Cox, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Jennifer Stevenson, PhD London School of Hygiene and Tropical Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01575613     History of Changes
Other Study ID Numbers: REDHOT_OPP1024438
Study First Received: March 19, 2012
Last Updated: November 26, 2012
Health Authority: The Netherlands: Radboud University Nijmegen Medical Centre, Dept Medical Microbiology

Keywords provided by Radboud University:
malaria
heterogeneity
transmission
elimination

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Lumefantrine
Artemether-lumefantrine combination
Artemisinins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 21, 2014