UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053873 |
|---|---|
| Receipt number | R000061498 |
| Scientific Title | Evaluation of the protective efficacy of OlysetPlus ceiling net on reducing malaria incidence in children in Ndhiwa Sub-County, Kenya: study protocol for a cluster-randomized controlled trial |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/15 14:23:41 |
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Basic information
Public title
Evaluation of the protective efficacy of OlysetPlus ceiling net on reducing malaria incidence in children in Ndhiwa Sub-County, Kenya: study protocol for a cluster-randomized controlled trial
Acronym
ICNGLR
Scientific Title
Evaluation of the protective efficacy of OlysetPlus ceiling net on reducing malaria incidence in children in Ndhiwa Sub-County, Kenya: study protocol for a cluster-randomized controlled trial
Scientific Title:Acronym
ICNGLR
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 in Ndhiwa Sub-County, Kenya
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study has four research domains: epidemiology, entomology, social aspects, and cost-effectiveness.
For the epidemiology domain, the primary objective is to determine the protective efficacy of OlysetPlus ceiling net in reducing malaria clinical incidence in children 6 months to 14 years old over 18 months post-intervention.
For the entomology domain, the primary objective is to evaluate the impact of OlysetPlus ceiling nets on the mosquito density of the primary malaria vector species.
For the social science domain, the primary objective is to assess the determinants of social acceptability of the OlysetPlus ceiling net in both the intervention and control arms.
For the cost-effectiveness domain, the primary objective is to determine the incremental cost-effectiveness ratios (ICERs) of adding the OlysetPlus ceiling net to existing malaria control interventions under field trial conditions.
Key secondary outcomes
For the epidemiology domain, 1) to determine the protective efficacy of OlysetPlus ceiling nets in reducing Plasmodium infection prevalence by PCR in all age groups at 6-, 12-, and 18- months post-intervention; (2) to determine the protective efficacy of OlysetPlus ceiling nets against the time-to-first Plasmodium infection; (3) to determine the spillover effects of OlysetPlus ceiling nets in reducing Plasmodium infection prevalence in all age groups at 6-, 12-, and 18-months post-intervention; and (4) to determine the protective efficacy of OlysetPlus ceiling net in reducing Plasmodium infection incidence in children 6 months to 14 years old over 18 months post-intervention.
For the entomology domain, (1) to determine the impact of OlysetPlus ceiling nets on entomological inoculation rate (EIR) and (2) to determine the prevalence of knockdown resistance (kdr) mutations in vectors.
For the social science domain, (1) to determine the feasibility of installing the OlysetPlus ceiling and (2) to determine the appropriateness of fit of the OlysetPlus ceiling net in the context of households in Ndhiwa Sub-County.
For the cost-effectiveness domain, (1) to establish the relative contribution to costs of the distinct programmatic elements and identify the inputs that contribute the most to overall costs, and (2) to estimate the potential cost of providing OlysetPlus ceiling net at a larger scale over 3 and 5 years under operational scenarios.
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
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
22000
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kaneko |
Organization
Osaka Metropolitan University
Division name
Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka, Japan
TEL
+81666453761
akirakaneko555@gmail.com
Public contact
Name of contact person
| 1st name | Yongra |
| Middle name | |
| Last name | Ko |
Organization
Tohoku University
Division name
Graduate school of medicine
Zip code
9800872
Address
2-1, Seiryomachi, Aoba, Sendai, Miyagi
TEL
+81227178006
Homepage URL
yurako0603@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
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
Mount Kenya University
Address
P. O. Box 342-01000, Thika, Kenya
Tel
+254720790796
info@mku.ac.ke
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
| 2024 | Year | 03 | Month | 15 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061498
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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