Comparing Chemoprevention Approaches for School-based Malaria Control

Malaria,Falciparum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244954
• Other study ID #: HP-00098250
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: November 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia in Children
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

Intervention

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

Locations

Country	Name	City	State
Malawi	Kamuzu University of Health Sciences	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Doris Duke Charitable Foundation, Kamuzu University of Health Sciences

Country where clinical trial is conducted

Malawi, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function test scores	standardized scores	6-8 weeks after the last intervention
Other	Reading test scores	standardized scores	6-8 weeks after the last intervention
Other	Math test scores	standardized scores	6-8 weeks after the last intervention
Other	School attendance	number of days missed based on registers and spot checks	from the first intervention to 6-8 weeks after the last intervention
Other	Mean infectiousness	regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness	from the first intervention to 6-8 weeks after the last intervention
Other	Performance characteristics of conventional RDT	compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score	through study completion, on average 6 months
Other	Performance characteristics of high-sensitivity RDT	compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score	through study completion, on average 6 months
Primary	P. falciparum infection	detected by polymerase chain reaction (PCR, binary)	6-8 weeks after the last intervention
Primary	P. falciparum gametocyte carriage	detected by q-rtPCR (binary)	6-8 weeks after the last intervention
Secondary	Number of participant with anemia	World Health Organization age-sex definitions (binary)	6-8 weeks after the last intervention
Secondary	Mean hemoglobin concentration	g/dL (continuous)	6-8 weeks after the last intervention
Secondary	Total parasite density	log transformed (continuous)	6-8 weeks after the last intervention
Secondary	Gametocyte density	log transformed (continuous)	6-8 weeks after the last intervention
Secondary	Rate of clinical malaria	cumulative incidence	from the first intervention to 6-8 weeks after the last intervention
Secondary	P. falciparum prevalence among household members	detected by PCR	6-8 weeks after the last intervention