UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053284 |
|---|---|
| Receipt number | R000060815 |
| Scientific Title | Evaluation of strategies for community-oriented malaria control in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/05/31 16:04:40 |
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Basic information
Public title
E-Learning and Mobile Money Reward Schemes to Promote Malaria Preventive Behavior
Acronym
ELandRewardMalaria
Scientific Title
Evaluation of strategies for community-oriented malaria control in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial
Scientific Title:Acronym
ELandRewardMalaria
Region
| Africa |
Condition
Condition
malaria
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of lottery incentive schemes and conditional cash transfers coupled with e-learning to reduce the malaria burden in Homa Bay, Kenya
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) malaria prevalence by PCR in children and adults at three and six months post-intervention; (2) change in the use of LLIN at three and six months post-intervention; and (3) change in malaria knowledge and perception among community residents at three and six months post-intervention
Key secondary outcomes
malaria prevalence by RDT in children and adults at three and six months post-intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: the malaria education video is shown, and the lotteries for rewards (the number of which is proportional to the number of RDT negative participants) are provided to randomly assigned households in randomly assigned clusters.
Interventions/Control_2
Intervention: the malaria education video is shown, and the conditional cash transfer (whose amount is proportional to the number of RDT negative participants at each household) is provided to randomly assigned households in randomly assigned clusters.
Interventions/Control_3
Control: no education video is shown, and no reward chances are provided to randomly unassigned households in the intervention arms and all households in the control arm.
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
The inclusion criteria for the COMC during the trial phase are (1) at least one permanent resident aged 18 years or older in the household and (2) informed consent provided by at least one adult in the household. The inclusion criteria for malaria prevalence surveys in communities are (1) aged more than one year, (2) living in the study area, and (3) providing informed consent. The inclusion criteria for prospective cohorts are (1) living in the study area at the time of the COMC intervention and (2) having no plan to leave or stay outside the study area for an extended period (longer than one month) over the 12-month follow-up period.
Key exclusion criteria
The exclusion criteria for the COMC during the trial phase are (1) no informed consent, (2) vacant dwelling structure, and (3) the dwelling structure is to be vacated or destroyed within the study period. The exclusion criteria for malaria prevalence surveys in communities are (1) severe illnesses, (2) living outside the study area, and (3) no informed consent. The exclusion criteria for prospective cohorts are (1) severe illnesses and (2) pregnancy during the COMC intervention.
Target sample size
9200
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
5458585
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka, Japan
TEL
666453761
akirakaneko555@gmail.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Matsumoto |
Organization
Otaru University of Commerce
Division name
Faculty of Commerce
Zip code
0478501
Address
Midori 3-5-21, Otaru, Hokkaido, Japan
TEL
134275310
Homepage URL
tmatsumoto@res.otaru-uc.ac.jp
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); Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mount Kenya University
Name of secondary funder(s)
Japan Society for the Promotion of Science (JSPS)
IRB Contact (For public release)
Organization
Otaru University of Commerce
Address
Midori 3-5-21, Otaru, Hokkaido, Japan
Tel
134275310
lib-kenkyu@office.otaru-uc.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
| 2024 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060815
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
