Household-level Impact of IPT of Malaria in Schoolchildren

February 22, 2021 updated by: College of Health Sciences, Makerere University

Evaluation of the Household-level Impact of a Single Round of Intermittent Preventive Treatment of Malaria in Schoolchildren: A Randomized Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Uganda
      • Kampala, Uganda, 256
        • Recruiting
        • Makerere College of Health Sciences
        • Contact:
        • Principal Investigator:
          • Joaniter I Nankabirwa, MSc CEB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm
A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals)
Drug: IPT with Dihydroartemisinin Piperaquine
A single dose/round of IPT with Dihydroartemisinin Piperaquine (40mg/320mg tabs, Fosun Pharmaceuticals)
No Intervention: Standard of care
Health information, no study drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasite prevalence
Time Frame: 1 month after the intervention
Parasitemia measured by microscopy
1 month after the intervention
Parasite prevalence
Time Frame: 3 months after the intervention
Parasitemia measured by microscopy
3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Anticipated)

June 3, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMC_HH impact

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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