CHILD (Child Health and Infection With Low Density) Malaria

NCT ID: NCT05567016

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2025-11-28

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Case Detection using molecular testing (ACDm)

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.

Group Type: EXPERIMENTAL

Active case detection using molecular testing (ACDm)

Intervention Type: OTHER

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.

Passive Case Detection using molecular testing (PCDm)

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.

Group Type: EXPERIMENTAL

Passive case detection using molecular testing (PCDm)

Intervention Type: OTHER

With fevers, participants will receive PCDm, in which qPCR will be done in RDT negatives with treatment using AL if positive.

Standard passive case detection (PCD)

Per standard of care, children will receive PCD using RDT.

Per standard of care, children will not receive malaria ACD.

Group Type: ACTIVE_COMPARATOR

Control (standard of care)

Intervention Type: OTHER

With fevers, participants will receive standard PCD using RDT with treatment using AL if positive.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Control (standard of care)

With fevers, participants will receive standard PCD using RDT with treatment using AL if positive.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 6 months to 10 years of age of age at enrollment

2. Primary residence in the study area during the study period

3. Agree to come to study clinic for any illness

4. Agree to avoid medications outside the study, even herbal medication

Exclusion Criteria

1. Another child from household already randomly selected for recruitment

2. Not able or does not provide informed consent

3. Need for emergency intervention

4. Known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or Stage 3 or 4 HIV/AIDS

5. Contraindications to artemether-lumefantrine (AL) including history of allergic reaction, weight under 5 kg

6. Participation in another active/ongoing intervention trial

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Ifakara Health Institute

OTHER

Sponsor Role: collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Chan Zuckerberg Biohub

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Hsiang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Ally Olotu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Institute

Locations

Kiwangwa and Fukayosi clinics

Bagamoyo, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 38538037 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form: Parent/Guardian consent for minor

View Document

Document Type: Informed Consent Form: Assent form for minors

View Document

Other Identifiers

U01AI155315

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DMID protocol 21-0046

Identifier Type: -

Identifier Source: org_study_id