Clinical trial NCT04660110: Household-level Impact of IPT of Malaria in Schoolchildren
Official title: Evaluation of the Household-level Impact of a Single Round of Intermittent Preventive Treatment of Malaria in Schoolchildren: A Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malaria
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will evaluate the household-level impact of IPT for malaria in schoolchildren on malaria transmission, using a randomized trial design. Two schools in Busia district will be randomly selected and randomize to either IPT with dihydroartemisinin piperaquine (DP, IPT arm), or standard of care (no intervention). A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals) will be given to the children in the intervention arm. The full dose will be given as oral tablets once a day for 3 consecutive days to all eligible children in the intervention school. Surveys will be conducted in households of 100 randomly selected children in each of the study arms at baseline, one month and three months following the intervention. The target population will include all household members of the selected households.

Detailed description: The most promising strategy to address the burden of malaria in school-aged children is intermittent preventive treatment with antimalarials (IPTsc). IPTsc has clearly been demonstrated to improve the health and educational attainment of schoolchildren. While the goal of IPTsc is improving the individual outcomes, reducing infections in schoolchildren, a primary reservoir for human-to-mosquito transmission may reduce overall transmission increasing the benefits and adding value to this intervention. In areas where the burden of malaria remains high despite implementation of currently available tools, IPTsc could act as a complimentary measure to reduce transmission incrementally while decreasing the burden of malaria in a vulnerable, high yield population. However, the benefits of IPTsc specifically targeting transmission reduction, have not widely been evaluated. We will evaluate impact of IPTsc with an antimalarial in schoolchildren on the malaria burden in household members in a high transmission area. The objective is to:

1. To determine the impact of intermittent preventive treatment of malaria in schoolchildren on malaria transmission at the household, as measured by the prevalence of parasitaemia at the household level.
2. To determine the impact of intermittent preventive treatment of malaria in schoolchildren on the health of the children as measured by the prevalence of parasitaemia among the children.

Two primary schools will be randomly selected from the list of the schools in Busia district. The list will act as the sampling frame for the school selection. Following the identification of the two schools to participate in the study. The schools will be randomized to either intervention or control arm.

A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals) will be given to the children in the intervention arm. The full dose will be given as oral tablets once a day for 3 consecutive days to all eligible children in the intervention school. The outcome is the prevalence of parasitemia in the schoolchildren and household members. To assess the impact of the intervention in schoolchildren, 216 children in the intervention school and 216 children in the control school will be randomly selected and assessed at baseline, 1 month and 3 months following the intervention. The same children will be assessed at the 3 school surveys. To assess the impact of the intervention on transmission at the household level, we will enroll 476 household members in the intervention arm and 476 household members in the control arm. Assessments will be conducted at baseline, 1 month and 3 months following the intervention.

Eligibility criteria: Inclusion Criteria:

Schools:

1. It is a government-run primary school,
2. Has actively enrolled pupils in primary grades 1-7

School children

1. Are enrolled at the participating school
2. Have parent/guardian consent to receive medication
3. Provided assent for those \> 8 years
4. Have no known allergy to study medication (Dihydroartemisinin piperaquine \[DP\])

Households

1. Have an adult \> 18 years of age
2. Agreement of the household head/designate to provide informed consent to participate in the three household surveys (baseline, 1-month post-intervention, and 3-months post-intervention)

Household members

1. Usual resident and present in the household the night before the survey
2. Agreement of resident or parent/guardian to provide informed consent
3. Agreement of children aged 8-17 years to provide assent

Exclusion Criteria:

-

Primary outcomes:
measure: Parasite prevalence
timeFrame: 1 month after the intervention
measure: Parasite prevalence
timeFrame: 3 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere College of Health Sciences
Study officials:
References:
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citation: Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.