UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050734 |
|---|---|
| Receipt number | R000057808 |
| Scientific Title | Do Personal Health Records Promote Malaria Prevention? An Experimental Investigation in Kenya |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/01/06 16:46:17 |
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Basic information
Public title
Do Personal Health Records Promote Malaria Prevention? An Experimental Investigation in Kenya
Acronym
PHRMalExpKny
Scientific Title
Do Personal Health Records Promote Malaria Prevention? An Experimental Investigation in Kenya
Scientific Title:Acronym
PHRMalExpKny
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 personal health records on subjective immunity, preventive behaviours, and test positivity of malaria in Homa Bay, Kenya
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) PCR malaria positivity; (2) RDT malaria positivity;
Key secondary outcomes
(1) subjective immunity against malaria; (2) preventive behaviours of malaria;
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Behavior,custom |
Interventions/Control_1
Intervention: own malaria RDT results are summarised and reminded to randomly selected individuals.
Interventions/Control_2
Control: no additional information is provided.
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
| 5 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Everyone included in the cohort survey study that recruits participants according to the following inclusion criteria: (1) being between 5 and 65 years old; (2) having no plans to leave the study area; (3)having no plans to live outside the study area for an extended period (longer than one month) over the entire duration of the study (i.e., 18-months) and (4) providing informed consent.
Key exclusion criteria
This study has no exclusion criteria other than the cohort survey study that has the following: (1) showing signs of severe illnesses; (2) having a known chronic condition or immunodeficiency, including HIV infection; (3) being pregnant at the time of enrolment; (4) planning to leave the study area; or (4) failing to provide informed consent.
Target sample size
325
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 | Masaru |
| Middle name | |
| Last name | Nagashima |
Organization
Waseda University
Division name
Waseda Institute for Advanced Study
Zip code
169-0051
Address
Rm 415-1, 1-21-1 Nishiwaseda, Shinjuku, Tokyo
TEL
352862120
Homepage URL
mnagashima@aoni.waseda.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Hitachi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Mount Kenya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan External Trade Organization Institute of Developing Economies
Address
3-2-2 Wakaba, Mihamaku, Chiba City, Chiba 261-8545
Tel
432999526
kenki@ide.go.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 | 04 | 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
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057808
