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Household-level Impact of IPT of Malaria in Schoolchildren

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
IPT with Dihydroartemisinin Piperaquine
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Makerere College of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention arm

Standard of care

Arm Description

A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals)

Health information, no study drugs

Outcomes

Primary Outcome Measures

Parasite prevalence
Parasitemia measured by microscopy
Parasite prevalence
Parasitemia measured by microscopy

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
February 22, 2021
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT04660110
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
June 3, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Active Comparator
Arm Description
A single dose/round of IPT with DP (40mg/320mg tabs, Fosun Pharmaceuticals)
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Health information, no study drugs
Intervention Type
Drug
Intervention Name(s)
IPT with Dihydroartemisinin Piperaquine
Intervention Description
A single dose/round of IPT with Dihydroartemisinin Piperaquine (40mg/320mg tabs, Fosun Pharmaceuticals)
Primary Outcome Measure Information:
Title
Parasite prevalence
Description
Parasitemia measured by microscopy
Time Frame
1 month after the intervention
Title
Parasite prevalence
Description
Parasitemia measured by microscopy
Time Frame
3 months after the intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Schools: It is a government-run primary school, Has actively enrolled pupils in primary grades 1-7 School children Are enrolled at the participating school Have parent/guardian consent to receive medication Provided assent for those > 8 years Have no known allergy to study medication (Dihydroartemisinin piperaquine [DP]) Households Have an adult > 18 years of age 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 Usual resident and present in the household the night before the survey Agreement of resident or parent/guardian to provide informed consent Agreement of children aged 8-17 years to provide assent Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joaniter Nankabirwa, PhD
Phone
256 772 676429
Email
jnankabirwa@yahoo.co.uk
Facility Information:
Facility Name
Makerere College of Health Sciences
City
Kampala
ZIP/Postal Code
256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaniter I Nankabirwa, MSc CEB
Phone
+256 772 676429
Email
jnankabirwa@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Joaniter I Nankabirwa, MSc CEB

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12460394
Citation
Kamya MR, Bakyaita NN, Talisuna AO, Were WM, Staedke SG. Increasing antimalarial drug resistance in Uganda and revision of the national drug policy. Trop Med Int Health. 2002 Dec;7(12):1031-41. doi: 10.1046/j.1365-3156.2002.00974.x.
Results Reference
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PubMed Identifier
25768015
Citation
Yeka A, Nankabirwa J, Mpimbaza A, Kigozi R, Arinaitwe E, Drakeley C, Greenhouse B, Kamya MR, Dorsey G, Staedke SG. Factors associated with malaria parasitemia, anemia and serological responses in a spectrum of epidemiological settings in Uganda. PLoS One. 2015 Mar 13;10(3):e0118901. doi: 10.1371/journal.pone.0118901. eCollection 2015.
Results Reference
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PubMed Identifier
16846756
Citation
Drakeley C, Sutherland C, Bousema JT, Sauerwein RW, Targett GA. The epidemiology of Plasmodium falciparum gametocytes: weapons of mass dispersion. Trends Parasitol. 2006 Sep;22(9):424-30. doi: 10.1016/j.pt.2006.07.001. Epub 2006 Jul 17.
Results Reference
background
PubMed Identifier
23589533
Citation
Nankabirwa J, Wandera B, Kiwanuka N, Staedke SG, Kamya MR, Brooker SJ. Asymptomatic Plasmodium infection and cognition among primary schoolchildren in a high malaria transmission setting in Uganda. Am J Trop Med Hyg. 2013 Jun;88(6):1102-1108. doi: 10.4269/ajtmh.12-0633. Epub 2013 Apr 15.
Results Reference
background
PubMed Identifier
25145389
Citation
Nankabirwa J, Brooker SJ, Clarke SE, Fernando D, Gitonga CW, Schellenberg D, Greenwood B. Malaria in school-age children in Africa: an increasingly important challenge. Trop Med Int Health. 2014 Nov;19(11):1294-309. doi: 10.1111/tmi.12374. Epub 2014 Aug 22.
Results Reference
background
PubMed Identifier
20976051
Citation
Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438.
Results Reference
background
PubMed Identifier
24621953
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.
Results Reference
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Household-level Impact of IPT of Malaria in Schoolchildren

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