Malaria
Conditions
Brief summary
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.
Interventions
Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).
Sponsors
National Malaria Control Program, Tanzania
National Institute for Medical Research, Tanzania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
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: 1. Includes parental/guardian informed consent 2. Assent by primary school children aged 11 years and above. 3. Aged 5-15 years. 4. Currently, lives within the pre-defined catchment area of study district; and 5. Will remain within the same area throughout the study period (preferably class five and below).
Exclusion criteria
1. Students at class 7 2. Currently enrolled in another study or participated in another investigational drug study within the last 30 days. 3. Known to have heart disease or a known cardiac ailment. 4. Reports known hypersensitivity to the study drugs. 5. Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol. 6. Having clinical features of severe anaemia 7. Febrile due to non-malaria illness at the time of recruitment. 8. Has apparent severe infection or any condition that requires hospitalization 9. Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and SS sickle cell. 10. Body weight \< 12 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical malaria incidence | from month 0 till month 12 of follow up | Malaria incidence will be collected in terms of number of episodes a child gets malaria. |
| Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions | 1 year from start of intervention | Efficiency in terms of percentage of children given a complete dose in each round. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in haemoglobin concentration | measured at month 12 | individual change in Haemoglobin before and after intervention |
| Number of participants with treatment-related adverse events | through study completion, an average of 1 year | Number of participants with treatment-related adverse events encountered by subjects per study arm |
| Acceptability of IPTsc in communities with high malaria endemicities | At month 8 of implementation | Through in depth interview in a guided questionnaire |
| Cardio safety profile by QTc prolongation from baseline | Day 1, 2,3 and 7 after before and after dosing | measured by ECG |
| Change in malaria incidence per 1000 population at local health facility level | from month 0 till month 12 of follow up | Number of malaria episodes before and after intervention in a respective ward |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of school children with malnutrition | 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. |
Countries
Tanzania
Outcome results
None listed