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School-Based Treatment With ACT to Reduce Transmission (START-IPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02009215
First Posted: December 11, 2013
Last Update Posted: September 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Infectious Diseases Research Collaboration, Uganda
University of California, San Francisco
University of Durham
Information provided by (Responsible Party):
Sarah Staedke, London School of Hygiene and Tropical Medicine
  Purpose
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.

Condition Intervention Phase
Malaria Drug: Dihydroartemisinin-piperaquine (DP) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 'SCHOOL-BASED TREATMENT WITH ACT TO REDUCE TRANSMISSION' (START-IPT): Evaluation of the Community Impact of Intermittent Preventive Treatment for Malaria in Ugandan Children: a Cluster Randomised Trial

Resource links provided by NLM:


Further study details as provided by Sarah Staedke, London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Parasite prevalence measured by microscopy in final community survey [ Time Frame: Approximately 1-4 months after completion of the intervention ]
    Proportion of thick blood smears that are positive for asexual parasites, as measured by microscopy.


Secondary Outcome Measures:
  • Entomologic inoculation rate (EIR) in the entomology survey [ Time Frame: Over approximately 1 year ]
    EIR will be defined as the number of infectious bites per person per year (the human biting rate multiplied by the sporozoite rate).

  • Parasite prevalence measured by microscopy in the final school survey [ Time Frame: During the final 1 month of the intervention ]
    Proportion of thick blood smears that are positive for asexual parasites, as measured by microscopy.


Other Outcome Measures:
  • Parasite prevalence measured by microscopy + LAMP in the final community survey [ Time Frame: Approximately 1-4 months after completion of the intervention ]
    Proportion of samples that are positive for asexual parasites by microscopy and LAMP

  • Prevalence of anaemia in children under-five in the final community survey [ Time Frame: Approximately 1-4 months after completion of the intervention ]
    Proportion of haemoglobin measurements categorised as mild, moderate, and severe anaemia according to WHO age-stratified guidelines, in children under five

  • Prevalence of gametocytaemia in the final community survey [ Time Frame: Approximately 1-4 months after completion of the intervention ]
    Proportion of thick blood smears that are positive for sexual parasites

  • Sporozoite rate in the entomology survey [ Time Frame: Over approximately 1 year ]
    Proportion of An gambiae infected with sporozoites

  • Prevalence of serious adverse events (SAEs) [ Time Frame: Over approximately 6 months, during the delivery of the intervention ]
    Proportion of children enrolled in the intervention experiencing any SAEs out of the total number of children enrolled; collected during prospective monitoring


Enrollment: 10746
Study Start Date: February 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermittent preventive treatment (IPT)
Dihydroartemisinin-piperaquine (DP)
Drug: Dihydroartemisinin-piperaquine (DP)
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.
Other Name: Duo-cotecxin
No Intervention: Control
No intermittent preventive treatment (IPT) with dihyroartemisinin-piperaquine (DP) will be given.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For IPT intervention

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age < 5 years
  2. Known allergy or history of adverse reaction to DP
  3. Menarche in female students
  4. Weight < 11 kg
  5. History of cardiac problems or fainting
  6. Family history of long QT syndrome
  7. Current use of medications known to prolong the QT interval
  8. Not able to locate parent or guardian, after at least three attempts including parent/teacher association (PTA) meetings and home visits
  9. Not able to locate the student at school, after at least three attempts
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009215


Locations
Uganda
Infectious Diseases Research Collaboration
Kampala, Uganda, PO Box 7475
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Infectious Diseases Research Collaboration, Uganda
University of California, San Francisco
University of Durham
Investigators
Principal Investigator: Sarah G Staedke, MD, PhD London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Sarah Staedke, Principal Investigator, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02009215     History of Changes
Other Study ID Numbers: ITCRAA6910
First Submitted: October 23, 2013
First Posted: December 11, 2013
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Sarah Staedke, London School of Hygiene and Tropical Medicine:
Uganda
intermittent preventive treatment
dihydroartemisinin-piperaquine
schoolchildren
malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents