Household-level Impact of IPT of Malaria in Schoolchildren

NCT04660110 | Unknown Phase 3 DMC

• 1 other identifier: SBMC_HH impact
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• Parasite prevalence

  Parasitemia measured by microscopy

  1 month after the intervention

• Parasite prevalence

  Parasitemia measured by microscopy

  3 months after the intervention

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Drug: IPT with Dihydroartemisinin Piperaquine

Standard of care

NO INTERVENTION

Health information, no study drugs

Interventions

IPT with Dihydroartemisinin Piperaquine DRUG

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

Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Makerere College of Health Sciences

Kampala, 256, Uganda

RECRUITING

Related Publications (7)

• 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.

  PMID: 12460394 BACKGROUND

• 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.

  PMID: 25768015 BACKGROUND

• 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.

  PMID: 16846756 BACKGROUND

• 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.

  PMID: 23589533 BACKGROUND

• 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.

  PMID: 25145389 BACKGROUND

• 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.

  PMID: 20976051 BACKGROUND

• 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.

  PMID: 24621953 BACKGROUND

MeSH Terms

Conditions

Malaria

Interventions

adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Joaniter Nankabirwa, PhD

CONTACT

256 772 676429; jnankabirwa@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 9, 2020
• Study Start: January 28, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 30, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)