Comparing Chemoprevention Approaches for School-based Malaria Control

NCT05244954 | Completed Phase 4 DMC

• 1 other identifier: HP-00098250
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 1

Brief Summary

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.

Conditions

Malaria,Falciparum; Anemia in Children

Keywords

malaria; school; chemoprevention; preventive treatment; screening and treatment; education; cognitive function; adolescent; hemoglobin

Outcome Measures

Primary Outcomes (2)

• P. falciparum infection

  detected by polymerase chain reaction (PCR, binary)

  6-8 weeks after the last intervention

• P. falciparum gametocyte carriage

  detected by q-rtPCR (binary)

  6-8 weeks after the last intervention

Secondary Outcomes (6)

• Number of participant with anemia

  6-8 weeks after the last intervention

• Mean hemoglobin concentration

  6-8 weeks after the last intervention

• Total parasite density

  6-8 weeks after the last intervention

• Gametocyte density

  6-8 weeks after the last intervention

• Rate of clinical malaria

  from the first intervention to 6-8 weeks after the last intervention

Other Outcomes (7)

• Cognitive function test scores

  6-8 weeks after the last intervention

• Reading test scores

  6-8 weeks after the last intervention

• Math test scores

  6-8 weeks after the last intervention

Study Arms (3)

Intermittent Screening and Treatment (IST)

EXPERIMENTAL

Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine

Intermittent Preventive Treatment (IPT)

EXPERIMENTAL

All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine

Control

NO INTERVENTION

Students will not receive preventive treatment.

Interventions

Dihydroartemisinin-Piperaquine DRUG

Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.

Also known as: DP, DuoCotecxin, Artekin, Eurartesim, Ridmal

Intermittent Preventive Treatment (IPT); Intermittent Screening and Treatment (IST)

Chloroquine DRUG

Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.

Also known as: Aralen

Intermittent Preventive Treatment (IPT); Intermittent Screening and Treatment (IST)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Students (enrolled in the primary intervention)
• Currently enrolled in the study school
• Plan to attend the study school for the remainder of the school year
• Parent/guardian available to provide written informed consent Household members (enrolled in the Household Prevalence survey)
• Slept in the household for most nights in the last month
• Age 6 months or older
• For minors, parent/guardian available to provide written informed consent

You may not qualify if:

• Students (enrolled in the primary intervention)
• Current evidence of severe malaria or danger signs
• Known adverse reaction to the study drugs
• History of cardiac problems or fainting
• Taking medications known to prolong QT
• Family history of prolonged QT
• Girls 10 years old and older with epilepsy or psoriasis Household members (enrolled in the Household Prevalence survey)
• Household with more than one school-age child enrolled in the study
• Current evidence of severe malaria or danger signs

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Kamuzu University of Health Sciences: collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Kamuzu University of Health Sciences

Blantyre, Malawi

Location

Related Publications (3)

• Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.

  PMID: 33767384 BACKGROUND

• Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.

  PMID: 33222799 BACKGROUND

• Halliday KE, Okello G, Turner EL, Njagi K, Mcharo C, Kengo J, Allen E, Dubeck MM, Jukes MC, Brooker SJ. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial. PLoS Med. 2014 Jan 28;11(1):e1001594. doi: 10.1371/journal.pmed.1001594. eCollection 2014 Jan.

  PMID: 24492859 BACKGROUND

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lauren Cohee, MD MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians processing samples will be blinded to participant's study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Assistant Professor

Model Details: Students will be randomized to intermittent screening-and-treatment (IST - Arm 1), intermittent preventive treatment (IPT - Arm 2), or control with no preventive treatment (Arm 3). Females less that 10 years of age (pre-menarche) and all males will be treated with DP if they are in Arm 2 or test positive in Arm 1. Females 10 years and older will be treated with chloroquine if they are in Arm 2 or test positive in Arm 1.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 17, 2022
• Study Start: February 1, 2022
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After results publication
• Access Criteria: Public access with registration to allow tracking

Locations

MA (1)