CHILD (Child Health and Infection With Low Density) Malaria
Child Health and Infection With Low Density (CHILD) Malaria, a Randomized Controlled Trial to Assess the Long-term Health and Socioeconomic Impact of Interventions Targeting Low-density Malaria Infection (LMI) Among Children in Tanzania
2 other identifiers
interventional
600
1 country
1
Brief Summary
This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedStudy Start
First participant enrolled
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2025
CompletedJanuary 29, 2026
January 1, 2026
2.4 years
September 30, 2022
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of all-cause sick visits
Number of sick visits to health facility per person time, excluding planned admissions for medical care, elective surgery, and trauma.
24-30 months from enrollment
Secondary Outcomes (31)
Prevalence of anemia
24-30 months from enrollment
Prevalence of underweight status
24-30 months from enrollment
Prevalence of stunting
24-30 months from enrollment
Prevalence of wasting
24-30 months from enrollment
Prevalence of malnutrition
24-30 months from enrollment
- +26 more secondary outcomes
Study Arms (3)
Active Case Detection using molecular testing (ACDm)
EXPERIMENTALPer standard of care, children will receive passive case detection (PCD) using rapid diagnostic test (RDT) if they present with fever. Children will receive malaria active case detection (ACD) using RDT and qPCR (quantitative polymerase chain reaction) three times yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive.
Passive Case Detection using molecular testing (PCDm)
EXPERIMENTALChildren who present with fever will receive PCD using RDT and qPCR with treatment using AL if RDT or qPCR positive. Per standard of care, children will not receive malaria ACD.
Standard passive case detection (PCD)
ACTIVE COMPARATORPer standard of care, children will receive PCD using RDT. Per standard of care, children will not receive malaria ACD.
Interventions
In the ACDm arm, children will receive ACD using RDT and qPCR 3x yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive. With fevers, participants will receive standard PCD using RDT.
With fevers, participants will receive PCDm, in which qPCR will be done in RDT negatives with treatment using AL if positive.
With fevers, participants will receive standard PCD using RDT with treatment using AL if positive.
Eligibility Criteria
You may qualify if:
- months to 10 years of age of age at enrollment
- Primary residence in the study area during the study period
- Agree to come to study clinic for any illness
- Agree to avoid medications outside the study, even herbal medication
You may not qualify if:
- Another child from household already randomly selected for recruitment
- Not able or does not provide informed consent
- Need for emergency intervention
- Known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or Stage 3 or 4 HIV/AIDS
- Contraindications to artemether-lumefantrine (AL) including history of allergic reaction, weight under 5 kg
- Participation in another active/ongoing intervention trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Ifakara Health Institutecollaborator
- Swiss Tropical & Public Health Institutecollaborator
- Stanford Universitycollaborator
- Chan Zuckerberg Biohubcollaborator
Study Sites (1)
Kiwangwa and Fukayosi clinics
Bagamoyo, Tanzania
Related Publications (1)
Jebiwott S, Gutapaka N, Sumari D, Loss G, Athuman T, Nyandele JP, Cummins H, Chemba M, Benjamin-Chung J, Gangar P, Wu X, Smith J, Chen I, Dorsey G, Fink G, Olotu A, Hsiang M. Child Health and Infection with Low Density (CHILD) malaria: a protocol for a randomised controlled trial to assess the long-term health and socioeconomic impacts of testing and treating low-density malaria infection among children in Tanzania. BMJ Open. 2024 Mar 27;14(3):e082227. doi: 10.1136/bmjopen-2023-082227.
PMID: 38538037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Hsiang, MD, MSc
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Ally Olotu, MD, PhD
Ifakara Health Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This will be an open label randomized controlled trial. Participants and personnel administering the intervention will be unblinded. Assessment of the primary outcome will be unblinded. Assessment of several secondary outcomes will be blinded as feasible.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2022
First Posted
October 5, 2022
Study Start
July 18, 2023
Primary Completion
November 28, 2025
Study Completion
November 28, 2025
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Upon completion of analysis and publication of main trial results
- Access Criteria
- Request and approval of PIs Planned analyses completed and main trial results published
Summary results information will be submitted to ClinicalTrials.gov within 12 months of completion of follow-up of all study participants. After completion of the clinical trial, un-blinding will be performed, and results will be disseminated widely by presentation at international scientific meetings, in reports and policy meetings for local, regional, and global stakeholders, and in publications in peer-reviewed journals. Upon completion of planned analyses and publication of the main trial results, data will be made available for research purposes to other individuals in the scientific community upon request to the PI and Consortium PIs. Informed consent documents for the study will include a specific statement relating to posting and sharing of study information at ClinicalTrials.gov, and in presentations, reports, and publications, and that no individual identities will ever be used in these materials and forums.