Comparing Chemoprevention Approaches for School-based Malaria Control
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intermittent Screening and Treatment (IST) 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
Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
Other Names:
Drug: Chloroquine
Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
Other Names:
|
Experimental: Intermittent Preventive Treatment (IPT) 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
Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
Other Names:
Drug: Chloroquine
Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
Other Names:
|
No Intervention: Control Students will not receive preventive treatment. |
Outcome Measures
Primary Outcome Measures
- P. falciparum infection [6-8 weeks after the last intervention]
detected by polymerase chain reaction (PCR, binary)
- P. falciparum gametocyte carriage [6-8 weeks after the last intervention]
detected by q-rtPCR (binary)
Secondary Outcome Measures
- Number of participant with anemia [6-8 weeks after the last intervention]
World Health Organization age-sex definitions (binary)
- Mean hemoglobin concentration [6-8 weeks after the last intervention]
g/dL (continuous)
- Total parasite density [6-8 weeks after the last intervention]
log transformed (continuous)
- Gametocyte density [6-8 weeks after the last intervention]
log transformed (continuous)
- Rate of clinical malaria [from the first intervention to 6-8 weeks after the last intervention]
cumulative incidence
- P. falciparum prevalence among household members [6-8 weeks after the last intervention]
detected by PCR
Other Outcome Measures
- Cognitive function test scores [6-8 weeks after the last intervention]
standardized scores
- Reading test scores [6-8 weeks after the last intervention]
standardized scores
- Math test scores [6-8 weeks after the last intervention]
standardized scores
- School attendance [from the first intervention to 6-8 weeks after the last intervention]
number of days missed based on registers and spot checks
- Mean infectiousness [from the first intervention to 6-8 weeks after the last intervention]
regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness
- Performance characteristics of conventional RDT [through study completion, on average 6 months]
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
- Performance characteristics of high-sensitivity RDT [through study completion, on average 6 months]
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kamuzu University of Health Sciences | Blantyre | Malawi |
Sponsors and Collaborators
- University of Maryland, Baltimore
- Kamuzu University of Health Sciences
- Doris Duke Charitable Foundation
Investigators
- Principal Investigator: Lauren Cohee, MD MS, University of Maryland School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- HP-00098250