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Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product

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ClinicalTrials.gov Identifier: NCT02288637
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist.

The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.


Condition or disease Intervention/treatment Phase
Malaria Anaemia Other: Olyset Plus LLIN Other: Conventional Olyset LLIN Other: IRS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3840 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes.
Study Start Date : September 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional Olyset LLIN
High coverage (>80% access) of conventional Olyset LLIN The arm is the standard of care from the National Malaria Control Program
Other: Conventional Olyset LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
  • Long Lasting Insecticidal Net
  • Olyset® Net
  • Sumitomo Chemical

Experimental: Olyset Plus LLIN
High coverage (>80% access) of Olyset Plus LLIN
Other: Olyset Plus LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use
Other Names:
  • Long Lasting Insecticidal Net
  • Olyset® Plus
  • Sumitomo chemical

Experimental: Conventional Olyset LLIN and IRS
High coverage (>80% access) of conventional Olyset LLIN and high coverage IRS (>80% of the household sprayed) with pirimiphos methyl CS
Other: Conventional Olyset LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
  • Long Lasting Insecticidal Net
  • Olyset® Net
  • Sumitomo Chemical

Other: IRS
Actellic CS (Syngenta), is a microcapsule formulation of the organophosphate insecticide, pirimiphos-methyl. Microencapsulation greatly extends the compound's residual life when applied to interior walls and ceilings. Evaluation by LSHTM in experimental huts in Tanzania showed residual activity of more than a year. Parallel trials in Benin against pyrethroid-resistant mosquitoes killed more than 80% of An. gambiae for up to 10 months.
Other Names:
  • Indoor Residual Spraying with Pirimiphos methyl CS
  • Actellic 300 CS
  • Syngenta

Experimental: Olyset Plus LLIN and IRS
High coverage (>80% access) of Olyset Plus LLIN and high coverage Indoor Residual Spraying (>80% of the household sprayed) with pirimiphos methyl CS
Other: Olyset Plus LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use
Other Names:
  • Long Lasting Insecticidal Net
  • Olyset® Plus
  • Sumitomo chemical

Other: Conventional Olyset LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
  • Long Lasting Insecticidal Net
  • Olyset® Net
  • Sumitomo Chemical




Primary Outcome Measures :
  1. Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms [ Time Frame: up to 15 months ]
    Malaria infection tested using Pf/Pan specific Malaria Rapid Diagnostic Test

  2. Difference in Entomological Inoculation Rate [ Time Frame: up to 15 months ]
    Malaria transmission measured by the Entomological Inoculation Rate (EIR) for each mosquito vector species.


Secondary Outcome Measures :
  1. Difference in Anaemia in children [ Time Frame: up to 15 months ]
  2. Difference in Mosquito density for each vector species [ Time Frame: Up to 15 months ]
  3. Difference in Sporozoite rate for each mosquito vector species [ Time Frame: up to 15 months ]
  4. Prevalence of serological antibodies to malaria antigens [ Time Frame: at baseline ]
  5. Change in prevalence of insecticide resistance markers including kdr and metabolic mechanisms [ Time Frame: at baseline and up to 15 months ]

Other Outcome Measures:
  1. Number of resident owning and using a Long Lasting Insecticidal Net [ Time Frame: at 3, 9 and 15 months post intervention ]
    Self reported ownership and usage using questionnaire confirmed by visual verification. Usage rate (proportion of study population sleeping under an ITN the previous night among those with access and among all population) of the two types of LLIN in the two post intervention years

  2. Number of houses and rooms sprayed [ Time Frame: at time of intervention ]
    Self reported praying coverage confirmed by presence of sticker on the door.

  3. Proportion of household resident reporting being at risk for malaria [ Time Frame: up to 15 months ]
    Self reported perception

  4. Change in attitude toward the interventions [ Time Frame: at baseline and up to 15 months ]
    Self reported attitude

  5. Cost of the intervention [ Time Frame: up to 3 months ]
    Based on start up, on-going and capital cost



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For the Household

  • Having a children from 6 months to 14 years old in the household
  • Provide written consent For the children
  • Having between 6 months to 14 years
  • Permanent residence in a selected household

Exclusion Criteria:

  • Children severely ill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288637


Locations
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Tanzania
District Muleba
Muleba, Kagera, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Mark Rowland, Phd London School of Hygiene and Tropical Medicine
Principal Investigator: Franklin W Mosha, Phd Kilimanjaro Christian Medical College
Principal Investigator: William Kisinza, Phd National Institute of Medical Research
Principal Investigator: Immo Kleinshmidt, Phd London School of Hygiene and Tropical Medicine
Principal Investigator: Natacha Protopopoff, Phd London School of Hygiene and Tropical Medicine

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02288637     History of Changes
Other Study ID Numbers: ITDCZC58
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases