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Evaluating ATSBs for Malaria Reduction in Kenya

Primary Purpose

Malaria

Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Attractive Targeted Sugar Bait (ATSB)
Sponsored by
Liverpool School of Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring ATSB, Malaria, Kenya

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligibility criteria for clusters: Inclusion criteria

  • A grouping of contiguous rural villages in Alego-Usonga and Rarieda sub-counties of Siaya County
  • A minimum of 200 households

Eligibility criteria for clusters: Exclusion criteria

  • Hard to reach in the rainy season
  • Refusal to participate by village elders

Eligibility criteria for participants in the cohort study: Inclusion criteria

  • A resident of a household within the core area of a study cluster, defined as living in the household in the recent four months and planning to live in the same household for the next 6.5 months
  • Aged ≥ 1 year and < 15 years at the time of enrollment
  • Written informed consent and/or assent

Eligibility criteria for participants in the cohort study: Exclusion criteria

  • A confirmed or suspected pregnancy. Pregnant women are excluded because they are eligible for intermittent preventive treatment of malaria in pregnancy (IPTp).
  • Taking daily cotrimoxazole prophylaxis (because this has antimalarial effects)
  • Known sickle cell disease (because they received antimalarial prophylaxis)
  • Contraindication to artemether-lumefantrine, the medication used for parasite clearance

Eligibility criteria for households for ATSB deployment: Inclusion criteria

--Households located within one of the 40 clusters (core or buffer area) randomly allocated to the trial intervention arm with a least one permanent resident

Eligibility criteria for households for ATSB deployment: Exclusion criteria

  • Refusal of consent by the head-of-household to deploy ATSB on the outer walls (intervention villages only)
  • Vacated compounds

Eligibility criteria for households for entomological monitoring: Inclusion criteria

  • Household located within the core area of the cluster
  • Head of household or his/her representative is at least 18 years of age
  • Written informed consent for the collection of entomological data by the head of household or representative

Eligibility criteria for households for entomological monitoring: Exclusion criteria --No residents sleeping in the household during the planned night of monitoring

Eligibility criteria for human landing catches: Inclusion criteria

  • Men aged 18 to 49 years
  • Willingness and ability to work late at night for up to 7 hours at a time
  • Willingness to take and tolerate a treatment regimen of the appropriate Kenya Ministry of Health (MoH) recommended antimalarial and chemoprophylaxis with 250 mg of mefloquine weekly to prevent malaria starting two weeks before the start of and until four weeks after completing HLCs
  • Written informed consent

Eligibility criteria for human landing catches: Exclusion criteria

  • Refusal/inability to work late at night for up to 7 hours at a time
  • Unwillingness to take or intolerance/allergy to appropriate MoH treatment regimen or chemoprophylaxis

Eligibility criteria for participants in rapid ethnographic methods evaluation (community members): Inclusion criteria

  • A resident of a household within an intervention area defined as an ATSB area during the main trial or an ASB area during any preliminary studies
  • Resides in a household at the time of ASB/ATSB deployment, where the ASB/ATSB was installed for at least one month.
  • 18 years of age or older if participating in focus group discussions; 15 years of age or older if participating in in-depth interviews

Eligibility criteria for participants in rapid ethnographic methods evaluation (community members): Exclusion criteria

--Unable to provide consent

Eligibility criteria for participants in rapid ethnographic methods evaluation (ATSB monitoring assistants): Inclusion criteria

  • Inclusion criteria ethnographic evaluation (ATSB monitoring assistants)
  • Serving as an ATSB monitoring assistant with experience installing ATSBs and monitoring the deployment Eighteen years of age or older

Eligibility criteria for participants in rapid ethnographic methods evaluation (ATSB monitoring assistants): Exclusion criteria

  • Less than one month experience (i.e. is new to the job)
  • Unable to provide consent

Sites / Locations

  • Naya Health CentreRecruiting
  • Benga DispensaryRecruiting
  • Boro DispensaryRecruiting
  • Manyuanda Health CentreRecruiting
  • Nyadhi DispensaryRecruiting
  • Ong'ielo Model Health CentreRecruiting
  • Rabar DispensaryRecruiting
  • Rageng'ni DispensaryRecruiting
  • Rambugu DispensaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Attractive Targeted Sugar Bait (ATSB)

Control

Arm Description

Clusters within the ATSB arm will have 2 to 3 ATSBs hung on all eligible structures in the cluster where consent from the corresponding compound has been given.

Clusters within the control arm will not receive ATSBs.

Outcomes

Primary Outcome Measures

Clinical malaria
The incidence rate of clinical malaria defined as current fever (axillary temperature of ≥37.5°C) or history of fever in last 48 hours and a positive rapid diagnostic test (RDT, pLDH or HRP2), in children aged 1-<15 years enrolled in the cohort study

Secondary Outcome Measures

Time to first malaria infection by PCR
The time to first malaria infection assessed by PCR in children aged 1-<15 years enrolled in a cohort study
Malaria infection incidence by RDT (pLDH)
The incidence rate of malaria infection detected by RDT (pLDH) in children aged 1-<15 years enrolled in a cohort study
Malaria infection prevalence by RDT (pLDH)
The prevalence of malaria infection detected by RDT (pLDH) in cross-sectional household surveys
Incidence of malaria illness (passive surveillance)
The incidence rate of malaria illness (sick-visit with a positive malaria rapid diagnostic test or microscopy) assessed by health-facility and community-based surveillance
Incidence of non-malaria illness (cohort)
The incidence rate of non-malaria illness in children aged 1-<15 years enrolled in a cohort study
Incidence of non-malaria illness (passive surveillance)
The incidence rate of non-malaria illness assessed by health-facility and community-based surveillance
Prevalence of non-malaria illness
The prevalence of non-malaria illness in cross-sectional household surveys
Malaria vector density
Entomological outcome: Malaria vector densities
Proportion of female anopheles mosquitoes older than three gonotrophic cycles,
Entomological outcome: The proportion of female anopheles mosquitoes older than three gonotrophic cycles.
Sporozoite rate
Entomological outcomes: Sporozoite rate
Entomological Inoculation Rate (EIR)
Entomological outcome: Entomological Inoculation Rate (EIR)
Non-Target Organisms (NTOs) attracted to ATSBs
Entomological outcome: Proportion of monitoring visits where NTOs were observed on bait stations
Markers of insecticide resistance (dinotefuran)
Entomological outcome: Proportion of mosquitoes with resistance to dinotefuran among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Markers of insecticide resistance (permethrin)
Entomological outcome: Proportion of mosquitoes with resistance to permethrin among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Markers of insecticide resistance (deltamethrin)
Entomological outcome: Proportion of mosquitoes with resistance to deltamethrin among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Antibody concentrations against malaria antigen MSP-1
Antibody concentration against merozoite surface protein-1 (MSP-1) among cohort participants
Antibody concentrations against malaria antigen CSP
Antibody concentration against circumsporozoite proteins (CSP) among cohort participants
Complexity of infection (COI)
The complexity of (malaria) infection assessed by molecular markers, including, but not limited to, 24-single-nucleotide polymorphisms (24-SNP) barcodes
Mosquito salivary antigens
Presence of mosquito salivary antigens in human blood as a measure for mosquito biting rates among cohort participants
AEs
Number of adverse events associated with misuse of ATSBs.
ATSB removal rate
The proportion of ATSBs that have been moved/removed
Perceptions of ATSBs
The proportion of household heads who perceive ATSBs as safe and effective out of all household head who consented to ATSB deployment on their household structures.
Household use of LLINs in the setting of ATSBs
The proportion of children aged 1-<15 years enrolled in a cohort study who used an LLIN the night prior
Household care seeking behavior in the setting of ATSBs
The proportion of children aged 1-<15 years enrolled in a cohort study who sought care for febrile illness
Cost-effectiveness
Incremental cost-effectiveness of ATSB above the standard of care measured through costing of intervention and efficacy outcomes

Full Information

First Posted
August 2, 2021
Last Updated
September 5, 2023
Sponsor
Liverpool School of Tropical Medicine
Collaborators
Kenya Medical Research Institute, Centers for Disease Control and Prevention, PATH, Kenya Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05219565
Brief Title
Evaluating ATSBs for Malaria Reduction in Kenya
Official Title
Phase III, Open-label, Community-based, Cluster Randomised Controlled Trial to Evaluate the Efficacy, Cost-effectiveness, and Acceptability of Attractive Targeted Sugar Baits (ATSB) for Malaria Burden Reduction in Western Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool School of Tropical Medicine
Collaborators
Kenya Medical Research Institute, Centers for Disease Control and Prevention, PATH, Kenya Ministry of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The effectiveness of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) in western Kenya are threatened by insecticide resistance and vector behaviour changes toward early evening and outdoor biting malaria vectors. New tools to control malaria are needed to reduce and even interrupt malaria transmission. Attractive Targeted Sugar Bait (ATSB) is a promising new intervention designed to attract and kill mosquitoes, including those that IRS and LLINs do not effectively target. The ATSB 'bait stations' are A4-sized panels containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran, to attract and kill the foraging vectors. Entomological field trials in western Mali showed that ATSBs successfully reduce mosquito densities and longevity and thus have the potential to reduce malaria transmission. In Kenya, the investigators will conduct an open-label cluster-randomized controlled trial in 80 village clusters (40 per arm) to evaluate the effect of ATSBs on the burden of malaria. During two years, households in half of these village clusters will receive two or three ATSB bait stations per household structure on exterior walls approximately 1.8 meters above the ground. ATSBs will be replaced every six months. The primary outcome will be the incidence of clinical malaria in children aged 1-<15 years enrolled in a prospective cohort followed monthly for about six months each during a 2-year period. Secondary outcomes include malaria infection prevalence assessed by rapid diagnostic tests through household surveys and the case burden of clinical malaria assessed by passive facility-based and community-based surveillance. The study includes entomological monitoring and nested acceptability, feasibility, and health economics studies. The stand-alone trial in western Kenya is a part of a multi-country ATSB consortium conducting similar trials in Zambia and Mali.
Detailed Description
The current malaria vector control tools, long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) are critically important and have saved many lives. However, their effectiveness in western Kenya is threatened by insecticide resistance and vector behaviour changes toward more early evening and outdoor biting malaria vectors. LLINs and IRS specifically target indoor-biting and indoor-resting mosquitoes. Malaria vectors exhibit different behavioural characteristics that mitigate the effectiveness of vector control strategies. For example, traditionally, An. gambiae s.s. has been regarded as human-biting with late-night indoor-feeding and indoor-resting behaviours, while An. Arabiensis is found more often in drier environments and is more zoophagic with outdoor biting and resting behaviours. Following LLINs and IRS's widespread scale-up, the dominant African vectors' distributions and behaviours changed with An. gambiae s.s. and An. Funestus (also an indoor human biter) diminishing in abundance relative to An. arabiensis. Subsequently, shifts towards earlier evening biting by An. Gambiae s.s. (before people enter houses to sleep under LLINs) and later biting by An. Funestus (biting in the morning after sunrise) are examples of behavioural plasticity enabling these species to avoid contact with the LLIN and IRS insecticides. There is a need for interventions that supplement and complement LLINs and IRS by killing mosquitoes outside houses using other biologic mechanisms (e.g., targeting sugar feeding behaviour). Furthermore, insecticides are required with novel modes of action that may restore sensitivity to pyrethroids by killing both pyrethroid-resistant and sensitive mosquitoes. Attractive Targeted Sugar Bait (ATSB) (the name was recently changed from Attractive Toxic Sugar Bait to highlight that it targets malaria vectors) is a promising new intervention that potentially fills the need for outdoor interventions with novel killing effects. ATSB 'bait stations' are A4-sized panels containing thickened fruit syrup laced with a neonicotinoid insecticide (dinotefuran) to attract and kill the foraging vectors. Entomological field trials in Mali showed that ATSBs successfully reduce mosquito densities and longevity and thus have the potential to reduce malaria transmission. Large scale efficacy studies are now needed to establish the efficacy of ATSB for controlling malaria transmission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
ATSB, Malaria, Kenya

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Using restricted randomization criteria, eighty clusters will be randomized 1:1 to either the intervention arm (ATSBs deployed throughout the cluster) or the control arm. The clusters will be followed in parallel for two years.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attractive Targeted Sugar Bait (ATSB)
Arm Type
Experimental
Arm Description
Clusters within the ATSB arm will have 2 to 3 ATSBs hung on all eligible structures in the cluster where consent from the corresponding compound has been given.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Clusters within the control arm will not receive ATSBs.
Intervention Type
Device
Intervention Name(s)
Attractive Targeted Sugar Bait (ATSB)
Other Intervention Name(s)
Attractive Toxic Sugar Bait
Intervention Description
An ATSB is a A4-sized panel containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran. The syrup-insecticide mixture is covered with a protective membrane that allows mosquitoes to feed through the membrane while preventing non-target organisms from feeding. This device is designed to attract and kill mosquitoes.
Primary Outcome Measure Information:
Title
Clinical malaria
Description
The incidence rate of clinical malaria defined as current fever (axillary temperature of ≥37.5°C) or history of fever in last 48 hours and a positive rapid diagnostic test (RDT, pLDH or HRP2), in children aged 1-<15 years enrolled in the cohort study
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Time to first malaria infection by PCR
Description
The time to first malaria infection assessed by PCR in children aged 1-<15 years enrolled in a cohort study
Time Frame
Two years
Title
Malaria infection incidence by RDT (pLDH)
Description
The incidence rate of malaria infection detected by RDT (pLDH) in children aged 1-<15 years enrolled in a cohort study
Time Frame
Two years
Title
Malaria infection prevalence by RDT (pLDH)
Description
The prevalence of malaria infection detected by RDT (pLDH) in cross-sectional household surveys
Time Frame
Two years
Title
Incidence of malaria illness (passive surveillance)
Description
The incidence rate of malaria illness (sick-visit with a positive malaria rapid diagnostic test or microscopy) assessed by health-facility and community-based surveillance
Time Frame
Two years
Title
Incidence of non-malaria illness (cohort)
Description
The incidence rate of non-malaria illness in children aged 1-<15 years enrolled in a cohort study
Time Frame
Two years
Title
Incidence of non-malaria illness (passive surveillance)
Description
The incidence rate of non-malaria illness assessed by health-facility and community-based surveillance
Time Frame
Two years
Title
Prevalence of non-malaria illness
Description
The prevalence of non-malaria illness in cross-sectional household surveys
Time Frame
Two years
Title
Malaria vector density
Description
Entomological outcome: Malaria vector densities
Time Frame
Two years
Title
Proportion of female anopheles mosquitoes older than three gonotrophic cycles,
Description
Entomological outcome: The proportion of female anopheles mosquitoes older than three gonotrophic cycles.
Time Frame
Two years
Title
Sporozoite rate
Description
Entomological outcomes: Sporozoite rate
Time Frame
Two years
Title
Entomological Inoculation Rate (EIR)
Description
Entomological outcome: Entomological Inoculation Rate (EIR)
Time Frame
Two years
Title
Non-Target Organisms (NTOs) attracted to ATSBs
Description
Entomological outcome: Proportion of monitoring visits where NTOs were observed on bait stations
Time Frame
Two years
Title
Markers of insecticide resistance (dinotefuran)
Description
Entomological outcome: Proportion of mosquitoes with resistance to dinotefuran among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Time Frame
Two years
Title
Markers of insecticide resistance (permethrin)
Description
Entomological outcome: Proportion of mosquitoes with resistance to permethrin among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Time Frame
Two years
Title
Markers of insecticide resistance (deltamethrin)
Description
Entomological outcome: Proportion of mosquitoes with resistance to deltamethrin among total mosquitoes collected in 4 WHO mosquito tubes in the trial area
Time Frame
Two years
Title
Antibody concentrations against malaria antigen MSP-1
Description
Antibody concentration against merozoite surface protein-1 (MSP-1) among cohort participants
Time Frame
Two years
Title
Antibody concentrations against malaria antigen CSP
Description
Antibody concentration against circumsporozoite proteins (CSP) among cohort participants
Time Frame
Two years
Title
Complexity of infection (COI)
Description
The complexity of (malaria) infection assessed by molecular markers, including, but not limited to, 24-single-nucleotide polymorphisms (24-SNP) barcodes
Time Frame
Two years
Title
Mosquito salivary antigens
Description
Presence of mosquito salivary antigens in human blood as a measure for mosquito biting rates among cohort participants
Time Frame
Two years
Title
AEs
Description
Number of adverse events associated with misuse of ATSBs.
Time Frame
Two years
Title
ATSB removal rate
Description
The proportion of ATSBs that have been moved/removed
Time Frame
Two years
Title
Perceptions of ATSBs
Description
The proportion of household heads who perceive ATSBs as safe and effective out of all household head who consented to ATSB deployment on their household structures.
Time Frame
Two years
Title
Household use of LLINs in the setting of ATSBs
Description
The proportion of children aged 1-<15 years enrolled in a cohort study who used an LLIN the night prior
Time Frame
Two years
Title
Household care seeking behavior in the setting of ATSBs
Description
The proportion of children aged 1-<15 years enrolled in a cohort study who sought care for febrile illness
Time Frame
Two years
Title
Cost-effectiveness
Description
Incremental cost-effectiveness of ATSB above the standard of care measured through costing of intervention and efficacy outcomes
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility criteria for clusters: Inclusion criteria A grouping of contiguous rural villages in Alego-Usonga and Rarieda sub-counties of Siaya County A minimum of 200 households Eligibility criteria for clusters: Exclusion criteria Hard to reach in the rainy season Refusal to participate by village elders Eligibility criteria for participants in the cohort study: Inclusion criteria A resident of a household within the core area of a study cluster, defined as living in the household in the recent four months and planning to live in the same household for the next 6.5 months Aged ≥ 1 year and < 15 years at the time of enrollment Written informed consent and/or assent Eligibility criteria for participants in the cohort study: Exclusion criteria A confirmed or suspected pregnancy. Pregnant women are excluded because they are eligible for intermittent preventive treatment of malaria in pregnancy (IPTp). Taking daily cotrimoxazole prophylaxis (because this has antimalarial effects) Known sickle cell disease (because they received antimalarial prophylaxis) Contraindication to artemether-lumefantrine, the medication used for parasite clearance Eligibility criteria for households for ATSB deployment: Inclusion criteria --Households located within one of the 40 clusters (core or buffer area) randomly allocated to the trial intervention arm with a least one permanent resident Eligibility criteria for households for ATSB deployment: Exclusion criteria Refusal of consent by the head-of-household to deploy ATSB on the outer walls (intervention villages only) Vacated compounds Eligibility criteria for households for entomological monitoring: Inclusion criteria Household located within the core area of the cluster Head of household or his/her representative is at least 18 years of age Written informed consent for the collection of entomological data by the head of household or representative Eligibility criteria for households for entomological monitoring: Exclusion criteria --No residents sleeping in the household during the planned night of monitoring Eligibility criteria for human landing catches: Inclusion criteria Men aged 18 to 49 years Willingness and ability to work late at night for up to 7 hours at a time Willingness to take and tolerate a treatment regimen of the appropriate Kenya Ministry of Health (MoH) recommended antimalarial and chemoprophylaxis with 250 mg of mefloquine weekly to prevent malaria starting two weeks before the start of and until four weeks after completing HLCs Written informed consent Eligibility criteria for human landing catches: Exclusion criteria Refusal/inability to work late at night for up to 7 hours at a time Unwillingness to take or intolerance/allergy to appropriate MoH treatment regimen or chemoprophylaxis Eligibility criteria for participants in rapid ethnographic methods evaluation (community members): Inclusion criteria A resident of a household within an intervention area defined as an ATSB area during the main trial or an ASB area during any preliminary studies Resides in a household at the time of ASB/ATSB deployment, where the ASB/ATSB was installed for at least one month. 18 years of age or older if participating in focus group discussions; 15 years of age or older if participating in in-depth interviews Eligibility criteria for participants in rapid ethnographic methods evaluation (community members): Exclusion criteria --Unable to provide consent Eligibility criteria for participants in rapid ethnographic methods evaluation (ATSB monitoring assistants): Inclusion criteria Inclusion criteria ethnographic evaluation (ATSB monitoring assistants) Serving as an ATSB monitoring assistant with experience installing ATSBs and monitoring the deployment Eighteen years of age or older Eligibility criteria for participants in rapid ethnographic methods evaluation (ATSB monitoring assistants): Exclusion criteria Less than one month experience (i.e. is new to the job) Unable to provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Samuels, MD, MHS
Phone
+254 724 255 633
Email
iyp2@cdc.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Feiko terKuile, MD, PHD
Phone
+441517053346
Email
feiko.terkuile@lstmed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Samuels, MD, MHS
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Ochomo
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naya Health Centre
City
Siaya
State/Province
Siaya County
ZIP/Postal Code
20200
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Benga Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254796946529
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Boro Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Manyuanda Health Centre
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Nyadhi Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Ong'ielo Model Health Centre
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Rabar Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Rageng'ni Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk
Facility Name
Rambugu Dispensary
City
Siaya
State/Province
Siaya County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kizito Obiet, Dip Medicine
Phone
+254721547082
Email
kizito.obiet@lstmed.ac.uk
First Name & Middle Initial & Last Name & Degree
Caroline Ogwang, MBChB
Phone
+254720221228
Email
caroline.ogwang@lstmed.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The full protocol will be available on request to any interested professional and may be published in a peer-reviewed journal or deposited in an online repository. Individual, de-identified participant data will be made available for meta-analyses as soon as the data analysis is completed, with the understanding that the meta-analysis results will not be published before the individual trial results without the prior agreement of the investigators. The de-identified data set of the complete participant-level data will be available for sharing purposes, such as via the WWARN repository platform (http://www.wwarn.org/working-together/sharing-data/accessing-data). A Data Access Committee will consider all requests for data for secondary analysis to ensure that the use of data is within the terms of consent and ethics approval.
IPD Sharing Time Frame
The full protocol and SAP will be published within the next 2 years. The individual de-identified data when data analysis is completed, within 6 months of trial completion.
IPD Sharing Access Criteria
A Data Access Committee will consider all requests for data for secondary analysis to ensure that the use of data is within the terms of consent and ethics approval.
Citations:
PubMed Identifier
23396849
Citation
Huho B, Briet O, Seyoum A, Sikaala C, Bayoh N, Gimnig J, Okumu F, Diallo D, Abdulla S, Smith T, Killeen G. Consistently high estimates for the proportion of human exposure to malaria vector populations occurring indoors in rural Africa. Int J Epidemiol. 2013 Feb;42(1):235-47. doi: 10.1093/ije/dys214. Epub 2013 Feb 9.
Results Reference
background
PubMed Identifier
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Evaluating ATSBs for Malaria Reduction in Kenya

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