Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506499755138 Date of Approval: 20/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ceiling Nets Against Malaria Research In Kenya
Official scientific title Evaluating the Impacts of Piperonyl Butoxide-Treated Ceiling Nets on Malaria Risk among Non-Users of Conventional Mosquito Nets in Homa Bay Country, Kenya: Study Protocol for a Household Randomized Control Trial
Brief summary describing the background and objectives of the trial Malaria control progress has stalled since 2015, with rising cases in many African countries. In 2021, WHO conditionally recommended house screening, but its effectiveness—particularly in combination with or as an alternative to LLINs—remains unclear. This trial evaluates the efficacy of PBO-ceiling nets, a novel house screening intervention, in high-risk Kenyan households with limited LLIN use. A total of 500 households in Homa Bay County, Kenya, will be randomized into three groups: (1) PBO-ceiling nets only, (2) PBO-LLINs, and (3) both interventions. The primary outcome is PCR-confirmed Plasmodium prevalence after 24 months. Secondary outcomes include entomological indicators using CDC light traps.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/07/2025
Actual trial start date
Anticipated date of last follow up 30/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 2500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ceiling nets plus LLIN two years Installation of PBO-ceiling nets and distribution of PBO-LLINs 50
Experimental Group ceiling nets only two years Installation of PBO ceiling nets 225
Control Group LLIN only two years Distribution of PBO-LLIN 225 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Residence in the study area during the study period. 2) Provision of informed consent by the participant or a parent/legal guardian before each survey. 3) Without LLINs or Ownership of only one LLIN. 4) All structures have fewer than four rooms. 5) All structures have open or partially open eaves. 1) With severe chronic diseases 2) Traveled for more than three weeks in the month prior to the survey 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 6 Month(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/06/2025 Mount Kenya University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
General Kago Road Thika 342-01000 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of Plasmodium infections 24 months post-intervention
Secondary Outcome Prevalence of Plasmodium infections 6 months post-intervention
Secondary Outcome Prevalence of Plasmodium infections 12 months post-intervention
Secondary Outcome Prevalence of Plasmodium infections 18 months post-intervention
Secondary Outcome Density of the primary malaria vectors 24 months post-intervention
Secondary Outcome Vector species composition 24 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Homa Bay County P.O Box 469, Homabay Homa Bay 40300 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Sumitomo Chemical Corporation 27-1, Shinkawa 2-chome, Chuo Tokyo Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Tropical Medicine Nagasaki University 1-12-4 Sakamoto Nagasaki 8528523 Japan University
COLLABORATORS
Name Street address City Postal code Country
Mount Kenya University General Kago Road Thika Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noboru Minakawa minakawa@nagasaki-u.ac.jp +81958197803 1-12-4 Sakamoto
City Postal code Country Position/Affiliation
Nagasaki Japan Nagasaki University
Role Name Email Phone Street address
Public Enquiries Jesse Gitaka jgitaka@mku.ac.ke +254709153000 General Kago Road
City Postal code Country Position/Affiliation
Thika Kenya Mount Kenya University
Role Name Email Phone Street address
Scientific Enquiries Yongra Ko yurako0603@gmail.com +81958197803 1-12-4 Sakamoto
City Postal code Country Position/Affiliation
Nagasaki Japan Nagasaki University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data that underlie the results reported in the study, including text, tables, figures, and appendices. Analytic Code,Informed Consent Form,Study Protocol When will data be available: IPD will be made available within 12 months after publication of the main study results. For how long will data be available: Data will be available for a minimum of 5 years from the time of first publication. With whom will data be shared: Researchers who provide a methodologically sound proposal for secondary analysis, meta-analysis, or individual-level pooled analysis. For what types of analyses: To achieve the aims outlined in the approved proposal, including secondary analyses that are scientifically sound and ethically justified. Mechanism for data access: Requests should be made to the principal investigator via email. Access will be granted subject to a data-sharing agreement and ethical approval where applicable.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information