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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045079
Receipt No. R000051478
Scientific Title Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial
Date of disclosure of the study information 2021/09/01
Last modified on 2021/08/06

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Basic information
Public title Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya
Acronym OCeNTILV
Scientific Title Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial
Scientific Title:Acronym OCeNTILV
Region
Africa

Condition
Condition malaria
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the effect of OlysetPlus ceiling nets on malaria burden on Mfangano Island, Homa Bay County, Kenya
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Prevalence of Plasmodium infections in children three to fifteen years six and twelve months after OlysetPlus ceiling net installation; (2) Incidence of malaria across all ages twelve months after net installation; (3) Density and composition of Anopheles vectors six and twelve months after net installation
Key secondary outcomes (1) Hemoglobin levels in children three to fifteen years six and twelve months after net installation; (2) Prevalence of antibodies against Anopheles salivary proteins and Plasmodium antigens across all ages twelve months after net installation; (3) Genomic profiles of Plasmodium parasites at six and twelve months after net installation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Intervention: OlysetPlus ceiling nets are installed permanently in houses randomly assigned to the intervention arm.
Interventions/Control_2 Control: No OlysetPlus ceiling nets are installed in houses randomly assigned to the control arm.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Households with at least one permanent resident on Mfangano Island
Key exclusion criteria (1) Temporary residents; (2) residents living in temporary structures; (3) residents planning to leave or stay outside their permanent home for longer than one month over the study period (12 months)
Target sample size 12000

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Kaneko
Organization Osaka City University
Division name Graduate School of Medicine
Zip code 545-8585
Address 1-4-3 Asahi-machi, Abeno-Ku, Osaka, Japan
TEL 666453761
Email akirakaneko555@gmail.com

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Kagaya
Organization Osaka City University
Division name Graduate School of Medicine
Zip code 545-8585
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 666453761
Homepage URL
Email wataru.kagaya@gmail.com

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan International Cooperation Agency-Science and Technology Research Partnership for Sustainable Development (JICA-SATREPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Mount Kenya Unversity
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka City University
Address 1-4-3 Asahi-machi, Abeno-ku, 545-8585 Osaka, Japan
Tel 666453611
Email ethics@med.osaka-cu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 09 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 08 Month 06 Day
Last modified on
2021 Year 08 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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