NCT02009215

Brief Summary

We propose to evaluate the community-level impact of intermittent preventive treatment (IPT) for malaria in schoolchildren on clinical outcomes and malaria transmission, using a cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be administered to schoolchildren monthly for up to six rounds of treatment during one school year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito vectors. Our proposal also includes health service research to evaluate the potential feasibility of taking the programme to scale, which will guide future research and implementation of the intervention, and help shape policies in Uganda and elsewhere in Africa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,746

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

October 23, 2013

Last Update Submit

September 23, 2015

Conditions

Malaria

Keywords

Ugandaintermittent preventive treatmentdihydroartemisinin-piperaquineschoolchildrenmalaria

Outcome Measures

Primary Outcomes (1)

  • Parasite prevalence measured by microscopy in final community survey

    Proportion of thick blood smears that are positive for asexual parasites, as measured by microscopy.

    Approximately 1-4 months after completion of the intervention

Secondary Outcomes (2)

  • Entomologic inoculation rate (EIR) in the entomology survey

    Over approximately 1 year

  • Parasite prevalence measured by microscopy in the final school survey

    During the final 1 month of the intervention

Other Outcomes (5)

  • Parasite prevalence measured by microscopy + LAMP in the final community survey

    Approximately 1-4 months after completion of the intervention

  • Prevalence of anaemia in children under-five in the final community survey

    Approximately 1-4 months after completion of the intervention

  • Prevalence of gametocytaemia in the final community survey

    Approximately 1-4 months after completion of the intervention

  • +2 more other outcomes

Study Arms (2)

Intermittent preventive treatment (IPT)

EXPERIMENTAL

Dihydroartemisinin-piperaquine (DP)

Drug: Dihydroartemisinin-piperaquine (DP)

Control

NO INTERVENTION

No intermittent preventive treatment (IPT) with dihyroartemisinin-piperaquine (DP) will be given.

Interventions

Dihydroartemisinin-piperaquine (DP)DRUG

Intermittent preventive treatment (IPT) with dihyroartemisinin-piperaquine (DP) will be delivered to participating students monthly, for up to 6 rounds of treatment during one school year. DP will be given once a day for 3 days, using full strength tablets (40/320mg) according to weight-based guidelines. Treatment will be directly observed, and will not be blinded.

Also known as: Duo-cotecxin
Intermittent preventive treatment (IPT)

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Student enrolled in a participating intervention school.
  • Willingness of parent/guardian to provide written informed consent.
  • Provision of written assent by the student (aged 8 years or above).

You may not qualify if:

  • Age \< 5 years
  • Known allergy or history of adverse reaction to DP
  • Menarche in female students
  • Weight \< 11 kg
  • History of cardiac problems or fainting
  • Family history of long QT syndrome
  • Current use of medications known to prolong the QT interval
  • Not able to locate parent or guardian, after at least three attempts including parent/teacher association (PTA) meetings and home visits
  • Not able to locate the student at school, after at least three attempts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, PO Box 7475, Uganda

Location

Related Publications (4)

  • 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: 20976051BACKGROUND

  • 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: 24621953BACKGROUND

  • Rehman AM, Maiteki-Sebuguzi C, Gonahasa S, Okiring J, Kigozi SP, Chandler CIR, Drakeley C, Dorsey G, Kamya MR, Staedke SG. Intermittent preventive treatment of malaria delivered to primary schoolchildren provided effective individual protection in Jinja, Uganda: secondary outcomes of a cluster-randomized trial (START-IPT). Malar J. 2019 Sep 18;18(1):318. doi: 10.1186/s12936-019-2954-0.

    PMID: 31533845DERIVED

  • Staedke SG, Maiteki-Sebuguzi C, Rehman AM, Kigozi SP, Gonahasa S, Okiring J, Lindsay SW, Kamya MR, Chandler CIR, Dorsey G, Drakeley C. Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial. Lancet Glob Health. 2018 Jun;6(6):e668-e679. doi: 10.1016/S2214-109X(18)30126-8. Epub 2018 Apr 13.

    PMID: 29661635DERIVED

Related Links

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Sarah G Staedke, MD, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2013

First Posted

December 11, 2013

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

UG(1)