Overview

Household-level Impact of IPT of Malaria in Schoolchildren

Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Makerere University
Treatments:
Artenimol
Dihydroartemisinin
Piperaquine
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:

-