NCT05567016

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Accepted

Summary

This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania

Detailed description

This is a 3-arm open-label randomized control trial of 600 children aged 6 months to 10 years in Tanzania, where transmission is low and a high proportion of infections are low-density. Standard of care based on passive case detection (PCD) using rapid diagnostic test (control arm) will be compared to two different approaches to detect and treat P. falciparum LMI: active case detection using molecular testing (ACDm) and PCD using molecular testing (PCDm). Aims are: 1. To assess the impact of standard PCD plus ACDm vs standard PCD on long-term child health 2. To assess the impact of PCDm vs standard PCD on long-term child health 3. To evaluate the cost-effectiveness of ACDm and PCDm

Conditions

• Malaria,Falciparum
• Malaria

Interventions

Type	Name	Description
OTHER	Active case detection using molecular testing (ACDm)	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.
OTHER	Passive case detection using molecular testing (PCDm)	With fevers, participants will receive PCDm, in which qPCR will be done in RDT negatives with treatment using AL if positive.
OTHER	Control (standard of care)	With fevers, participants will receive standard PCD using RDT with treatment using AL if positive.

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2022-10-05
• Last updated: 2026-01-29

Locations

1 site across 1 country: Tanzania