Clinical trial NCT05244954: Comparing Chemoprevention Approaches for School-based Malaria Control
Official title: Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria,Falciparum
Anemia in Children
Keywords: malaria
school
chemoprevention
preventive treatment
screening and treatment
education
cognitive function
adolescent
hemoglobin
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Doris Duke Charitable Foundation
First posted: 2022-02-17
Enrollment: 746
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Students will be enrolled in a single primary school in Machinga District, Malawi. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: P. falciparum infection
timeFrame: 6-8 weeks after the last intervention
measure: P. falciparum gametocyte carriage
timeFrame: 6-8 weeks after the last intervention
Secondary outcomes:
measure: Number of participant with anemia
timeFrame: 6-8 weeks after the last intervention
measure: Mean hemoglobin concentration
timeFrame: 6-8 weeks after the last intervention
measure: Total parasite density
timeFrame: 6-8 weeks after the last intervention
measure: Gametocyte density
timeFrame: 6-8 weeks after the last intervention
measure: Rate of clinical malaria
timeFrame: from the first intervention to 6-8 weeks after the last intervention
measure: P. falciparum prevalence among household members
timeFrame: 6-8 weeks after the last intervention
Other outcomes:
measure: Cognitive function test scores
timeFrame: 6-8 weeks after the last intervention
measure: Reading test scores
timeFrame: 6-8 weeks after the last intervention
measure: Math test scores
timeFrame: 6-8 weeks after the last intervention
measure: School attendance
timeFrame: from the first intervention to 6-8 weeks after the last intervention
measure: Mean infectiousness
timeFrame: from the first intervention to 6-8 weeks after the last intervention
measure: Performance characteristics of conventional RDT
timeFrame: through study completion, on average 6 months
measure: Performance characteristics of high-sensitivity RDT
timeFrame: through study completion, on average 6 months
Locations:
city: Blantyre
country: Malawi
facility: Kamuzu University of Health Sciences
Study officials:
affiliation: University of Maryland, Baltimore
name: Lauren Cohee, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.