UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047728 |
|---|---|
| Receipt number | 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 | 2025/07/10 13:33:10 |
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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
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
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)
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
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
No longer recruiting
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
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054417
