Handeni Town Council, Handeni and Kilindi Districts
Tanga, Tanzania
NCT Number: NCT04245033
In Tanzania, according to the National Malaria Control Programme (NMCP), malaria prevalence has declined from an average of 18.1% in 2008 to 7% in 2017, marked as an epidemiological transition from meso-endemic to hypo-endemic levels with variation across and within regions and/or councils. Children of school-age have become increasingly more vulnerable as compared to those aged less than five years. In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, accounting for around 50% of the mortality, 13-50% of all school absenteeism. The NMCP developed a supplementary malaria midterm strategic plan (SMMSP 2018-2020) to customise malaria interventions by stratifying the burden of malaria in Tanzania mainland and recommended use of Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment in school children (IPTsc) in high malaria strata. The investigators plan to evaluate the implementation of IPTsc using DP, given three times a year, for evidence on the operational feasibility and effectiveness of IPTsc on clinical malaria incidence at a high endemic area in Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC of Tanga region, Tanzania.
The study is an effectiveness-implementation hybrid trial to assess feasibility and effectiveness of IPTsc using DP against standard of care (control). Wards in the three study districts (Handeni DC, Handeni TC and Kilindi DC) will be the randomisation unit (clusters). Each ward will be randomised to implement IPTsc or not (control). In all wards in the IPTsc arm, the interventional drugs (DP) will be given at an interval of four months, three times a year. For study evaluation of the impact of intervention, in each district representative randomly selected wards, will provide randomly selected school per ward (24 in total) to formulate part of evaluable children per intervention. Mixed design methods will be used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive school children health package.
The study is expected to be operationally feasible given existing school health programme for Neglected Tropical Disease (NTD) control and the school net programme (SNP). IPTsc is expected to increase malaria case management effectiveness and to have additional effect in reducing the burden of disease on top of optimal access to malaria case management (MCM) and malaria vector control (MVC) initiatives e.g. early diagnosis and treatment, and insecticide-treated nets (ITNs) coverage, respectively.
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Notify Me5 year–15 year
All sexes
Interventional
Phase 4
Tanga, Tanzania
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The following eligibility criteria are used to enroll participants on for close monitoring follow ups assessing the effectiveness part of the study protocol.
Inclusion criteria
Exclusion criteria
Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).
Time frame: 1 year from start of intervention
Efficiency in terms of percentage of children given a complete dose in each round.
Time frame: from month 0 till month 12 of follow up
Malaria incidence will be collected in terms of number of episodes a child gets malaria.
Time frame: from month 0 till month 12 of follow up
Number of malaria episodes before and after intervention in a respective ward
Time frame: measured at month 12
individual change in Haemoglobin before and after intervention
Time frame: through study completion, an average of 1 year"
Number of participants with treatment-related adverse events encountered by subjects per study arm
Time frame: Day 1, 2,3 and 7 after before and after dosing
measured by ECG
Time frame: At month 8 of implementation
Through in depth interview in a guided questionnaire
Time frame: at month 0 (baseline) and at month 12.
Weight and height will be combined to report BMI in kg/m^2, WHO's BMI z-score will be used to categorise nutrition status.
National Institute for Medical Research, Tanzania
Other Gov
Acronym: IPTsc
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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