An interventional study of Active case detection using molecular testing (ACDm) and Passive case detection using molecular testing (PCDm) in Malaria,Falciparum and Malaria, sponsored by University of California, San Francisco. Completed at 1 site in Tanzania. Open to participants aged 6 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania
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:
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 600 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Per 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.
Other: Active case detection using molecular testing (ACDm)
Children 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.
Other: Passive case detection using molecular testing (PCDm)
Per standard of care, children will receive PCD using RDT. Per standard of care, children will not receive malaria ACD.
Other: Control (standard of care)
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.
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.
Time frame: 24-30 months from enrollment
Prevalence of anemia
Proportion of routine Hb measurements that are low (\<11 g/dL) or moderate-severe low (\<8 g/dL)
Time frame: 24-30 months from enrollment
Prevalence of underweight status
Prevalence of underweight status will be defined as the percentage of participants with low weight for age z-scores of less than -2. The World Health Organization (WHO) anthropometric indices will be utilized for standards.
Time frame: 24-30 months from enrollment
Prevalence of stunting
Prevalence of stunting will be defined as the percentage of participants with low height for age z-scores of less than -2. The World Health Organization (WHO) anthropometric indices will be utilized for standards.
Time frame: 24-30 months from enrollment
Prevalence of wasting
Prevalence of wasting will be defined as the percentage of participants with low weight for height z-scores of less than -2. The World Health Organization (WHO) anthropometric indices will be utilized for standards.
Time frame: 24-30 months from enrollment
Prevalence of malnutrition
Prevalence of malnutrition will be defined as the percentage of participants with a z-score of -3 to -2 indicating moderate malnutrition or a z-score of less than -3 indicating severe malnutrition in any of the following: weight for age, height for age, or weight for height.
Time frame: 24-30 months from enrollment
Prevalence of vomiting following administration of study drugs
Vomiting immediately or within 30minutes following administration of study drugs and measures of non-adherence.
Time frame: 24-30 months from enrollment
All-cause fever episodes
Number of fever episodes (reported fever in the past 48hrs and/or axillary temperature of ≥37.5°C) per person time
Time frame: 24-30 months from enrollment
Incidence of clinical symptoms
Number of days with overall symptoms reported as moderate (≥3 on a 5-point scale) per person time
Time frame: 24-30 months from enrollment
Incidence of clinical malaria
New episodes of positive malaria test (with fever or other clinical symptoms) per person time
Time frame: 24-30 months from enrollment
Proportion of fever episodes with clinical failure
Proportion of fever episodes that lead to clinical failure, defined as persistent or worsening symptoms assessed 7 and 28 days after initial evaluation.
Time frame: 24-30 months from enrollment
Prevalence of parasitemia
Proportion of routine samples with parasites detected by microscopy or quantitative polymerase chain reaction (qPCR).
Time frame: 24-30 months from enrollment
Incidence in antibiotics prescribed
Number of antibiotic regimens prescribed per person time
Time frame: 24-30 months from enrollment
Cognitive ability among children 0-3.4 years of age on the Global Scales of Early Development (GSED)
GSED is a validated instrument that measures population-level early childhood development. The tool measures children's early skills and behaviors in four primary domains: motor, cognitive, language, and social-emotional development.Measures will be normalized within our sample to mean 0 and standard deviation 1, with higher scores indicating better test performance.
Time frame: 24-30 months from enrollment
Cognitive ability among children 3.5-5 years of age on the International Development and Early Learning Assessment (IDELA)
The IDELA is a validated, global tool that uses direct child assessment to measure early learning and development across 4 core domains (Emergent Literacy, Emergent Numeracy, Motor, Social-emotional). Scores range from 0-100% as a percentage of correct tasks averaged across the 4 domains. Measures will be normalized within our sample to mean 0 and standard deviation 1, with higher scores indicating better test performance.
Time frame: 24-30 months from enrollment
Cognitive ability among children 6-12 years of age on the East Africa Neurodevelopment Assessment Tool
The East African Neurodevelopment Assessment Tool is a locally adapted modification of the Kaufman Brief Intelligence Test 2nd Ed. The test assesses 3 core metrics including general intelligence, executive function, literacy skills - in addition to behavioral and emotional development. Measures will be normalized within our sample to mean 0 and standard deviation 1, with higher scores indicating better test performance.
Time frame: 24-30 months from enrollment
Sustained attention among children 5-8 years of age on the Pencil Tapping Test
The pencil tapping test is one of the tasks in the Preschool Self-Regulation Assessment (PSRA) and is used to assess inhibitory control in younger children. The child and an assessor have pencils, and child is instructed to tap one/two times(s) depending on what assessor does, with the number of correct responses scored. Measures will be normalized within our sample to mean 0 and standard deviation 1, with higher scores indicating better test performance.
Time frame: 24-30 months from enrollment
Sustained attention among children 9-12 years of age on the Code Transmission Test, a local adaptation of the Test of Everyday Attention for Children(TEA-Ch)
Code transmission test is a sub-test of Test of Everyday Attention for Children (TEA-Ch) used for assessment of sustained attention in children. In the test, the child must remember spoken digits, and remember the digit that comes before sequence of numbers. Child is scored on completed and correct answers. Measures will be normalized within our sample to mean 0 and standard deviation 1, with higher scores indicating better test performance.
Time frame: 24-30 months from enrollment
Incidence of school absenteeism
The number of days of school absenteeism for any reason including illness.
Time frame: 24-30 months from enrollment
School performance
School performance will be defined as the incidence of school advancement to the next grade.
Time frame: 24-30 months from enrollment
Socioeconomic costs to participant
Estimated long-term income loss due to impaired early childhood development
Time frame: 24-30 months from enrollment
Socioeconomic costs to family
Total caregiver-reported costs of sick visits and transport to sick visits plus estimated loss of income from number of days of caregiver work absenteeism.
Time frame: 24-30 months from enrollment
Socioeconomic costs to health system
Estimated costs of testing and treatment for caregiver-reported number of sick visits.
Time frame: 24-30 months from enrollment
Cost effectiveness
Cost per outcome averted (e.g., per sick visit averted, per disability adjusted life years (DALYs), and per economic dollar saved, etc.)
Time frame: 24-30 months from enrollment
Prevalence of systemic inflammation
Proportion of sick visits with elevated elevated C-reactive pep-tide (CRP)
Time frame: 24-30 months from enrollment
Proportion with antimalarial antibodies against P.falciparum
Percentage of patients with antimalarial antibodies
Time frame: 24-30 months from enrollment
Proportion with biomarkers of inflammation
Percentage of patients with elevated cytokines
Time frame: 24-30 months from enrollment
Proportion with general antibody responses to vaccines
Percentage of patients with vaccine antibodies
Time frame: 24-30 months from enrollment
Proportion with general antibody responses to common pathogens
Percentage of patients with common pathogen antibodies
Time frame: 24-30 months from enrollment
Incidence of adverse events (AEs)
Number of AEs per person time. AEs will be considered as any grade 3-4 AE or serious adverse event (SAE); individual AEs; or AEs related to study drugs.
Time frame: 24-30 months from enrollment
Incidence of wasting
Incidence proportion of wasting will be defined for each age range of measurement. It is defined as the proportion of children not wasted at the start of the period who became wasted during the age period (the proportion of children who had the onset of new episodes during the period). Incident wasting episodes are defined as a change in weight-for-length z-scores from above -2 Z in the prior measurement to below -2 Z in the current measurement. We will define incident severe wasting analogously using a -3 Z cutoff. We will assume a 60-day washout period before a new wasting episode could occur.
Time frame: 24-30 months from enrollment
Incidence of stunting
Incidence proportion of stunting will be defined for each age range of measurement. It is defined as the proportion of children not stunted at the start of the period who became stunted during the age period. Incident stunting episodes will be defined as a change in length-for-age z-scores from above -2 Z in the prior measurement to below -2 Z in the current measurement. We will define incident severe stunting analogously using a -3 Z cutoff.
Time frame: 24-30 months from enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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
Ran from Jul 2023 to primary completion in Nov 2025, 28 months.
Of 24 interventional studies with no phase under Malaria, Falciparum, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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