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Last Updated: 16/01/2023
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
Objectives
The study aims to determine the long term health and socioeconomic effects of detecting and treating low density malaria infection in children residing low transmission settings.
Firstly, the study will assess the impact of standard passive case detection (PCD) plus active case detection using molecular testing (ACDm) vs standard PCD alone on long-term child health. 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. Both arms will receive standard PCD using RDT. We hypothesize that adding ACDm will lower incidence of all-cause sick visits.
Secondly, it will assess the impact of PCDm vs standard PCD on long-term child health. For fever episodes, both arms will receive standard PCD using RDT. In the PCDm arm, qPCR will be done on RDT negatives with treatment using AL if positive. Neither arm will receive ACD. We hypothesize that PCDm vs standard PCD will lower incidence of all-cause sick visits.
Thirdly, we will evaluate cost effectiveness of ACDm and PCDm where the socioeconomic cost data from aims 1 and 2 above will be used to compare each intervention to control and calculate outcomes including cost per sick visit averted per disability adjusted life years (DALYs) and per economic dollar saved.
Therefore, the significance of our study lies in the increasing worldwide relevance of LMI and its associated morbidity for children; the importance of child health for global health, society, economy; and the potential for findings to lead to policy and practice changes.
University of California San Francisco (UCSF), United States
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).
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)
Apr 2022 — Mar 2027
$2.18M