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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047728
Receipt No. R000054417
Scientific Title Impact evaluation of lottery incentives for malaria elimination in Homa Bay
Date of disclosure of the study information 2022/07/01
Last modified on 2022/06/29

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Basic information
Public title Impact evaluation of lottery incentives for malaria elimination in Homa Bay
Acronym EvalLISHB
Scientific Title Impact evaluation of lottery incentives for malaria elimination in Homa Bay
Scientific Title:Acronym EvalLISHB
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 6 and 12 months post intervention; (2) monthly malaria incidence in prospective cohorts for 12 months post intervention; (3) antibodies (IgG) against Anopheles salivary proteins gSG6 and cE5 in prospective cohorts at 6 and 12 months post intervention; (4) change in anemia rate in children and adults at 6 and 12 months post intervention; (5) change in the appropriate use of LLIN; and (6) change in malaria knowledge and perception among community residents at 6 and 12 months post intervention
Key secondary outcomes malaria prevalence by RDT in children and adults at 6 and 12 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 NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention_1: malaria education video is shown; lotteries for rewards (number of rewards is proportional to the number of RDT negative participants) are provided to randomly assigned households in randomly assigned clusters
Interventions/Control_2 Intervention_2: malaria education video is shown; conditional cash transfer (amount is proportional to the number of RDT negative participants) 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 For community-oriented malaria control (COMC) intervention: (1) at least one permanent resident aged 18 years or older in the household; (2) informed consent provided by at least one adult in the household
For malaria and anemia prevalence survey: (1) aged 1 year or older; (2) living in the study area; (3) providing informed consent
For prospective cohort survey: (1) living in the study area at the time of COMC intervention; (2) have no plan to leave or stay outside the study area for longer than one month over the 12-month follow-up period
Key exclusion criteria For COMC intervention: (1) no informed consent; (2) vacant dwelling structure; (3) dwelling structure is to be vacated or destroyed within the study period
For malaria and anemia prevalence survey: (1) severe illnesses; (2) living outside the study area; (3) no informed consent
For prospective cohort survey: (1) severe illnesses; (2) pregnancy at the time of COMC intervention
Target sample size 10000

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 666453761
Email 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 047-8501
Address Midori 3-5-21, Otaru, Hokkaido, Japan
TEL 134274310
Homepage URL
Email tmatsumoto@res.otaru-uc.ac.jp

Sponsor
Institute Osaka Metropolitan 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 University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Otaru University of Commerce
Address Midori 3-5-21, Otaru, Hokkaido, Japan
Tel 134275310
Email 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
2022 Year 07 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 Enrolling by invitation
Date of protocol fixation
2022 Year 03 Month 03 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2023 Year 05 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
2022 Year 05 Month 12 Day
Last modified on
2022 Year 06 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054417

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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