Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Un… (NCT07362498) | Clinical Trial Compass
CompletedNot Applicable
Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya
Kenya316 participantsStarted 2020-06-01
Plain-language summary
This implementation study evaluated the health systems feasibility, economic costs, and stakeholder acceptability of deploying multiple first-line therapies (MFTs) that were of the artemisinin-based combination therapies (ACTs) type, for uncomplicated malaria in Western Kenya. The study included a nested observational molecular surveillance of antimalarial resistance markers in Plasmodium falciparum parasites. The implementation program involved adaptive cycling of four ACTs across 28 health facilities over 28 months (June 2020 - October 2022) with and extension to January 2024 in one geographic area (Mfangano Island). Health systems outcomes (feasibility, costs, acceptability) are reported in Cole et al., Malaria Journal 2024. Molecular surveillance outcomes (resistance marker prevalence and temporal trends) are reported in a companion manuscript currently under peer-review.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 5 years or older
* Clinical diagnosis of uncomplicated malaria
* Confirmed Plasmodium falciparum infection by rapid diagnostic test (RDT) or microscopy
* Presenting at participating health facility for malaria treatment
* Able and willing to provide informed consent (or parental/guardian consent for minors under 18 years)
* Resident of study catchment area
* For molecular surveillance substudy: willingness to provide dried blood spot sample
Exclusion Criteria:
* Pregnant women (due to contraindications for some study medications in first trimester and lack of safety data)
* Children under 5 years of age (due to lack of pediatric formulations for some study medications)
* Severe or complicated malaria requiring parenteral treatment or hospitalization
* Known hypersensitivity or contraindication to any of the study artemisinin-based combination therapies
* Unable to take oral medications
* Previous participation in current treatment episode (repeat visits)
* Concurrent participation in other interventional malaria treatment studies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health Systems Feasibility - Commodity Management Score
Timeframe: June 2020 to January 2024
2
Health Systems Feasibility - Human Resources and Information Systems Score