Clinical trial NCT04245033: Evaluation of the Implementation and Effectiveness of Intermittent Preventive Treatment for Malaria Using Dihydroartemisinin-piperaquine on Reducing Malaria Burden in School Aged Children in Tanzania
Official title: Evaluation of the Implementation and Effectiveness of Intermittent Preventive Treatment for Malaria Using Dihydroartemisinin-piperaquine on Reducing Malaria Burden in School Aged Children in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: National Malaria Control Program, Tanzania
First posted: 2020-01-28
Enrollment: 4100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions
timeFrame: 1 year from start of intervention
measure: Clinical malaria incidence
timeFrame: from month 0 till month 12 of follow up
Secondary outcomes:
measure: Change in malaria incidence per 1000 population at local health facility level
timeFrame: from month 0 till month 12 of follow up
measure: Change from baseline in haemoglobin concentration
timeFrame: measured at month 12
measure: Number of participants with treatment-related adverse events
timeFrame: through study completion, an average of 1 year"
measure: Cardio safety profile by QTc prolongation from baseline
timeFrame: Day 1, 2,3 and 7 after before and after dosing
measure: Acceptability of IPTsc in communities with high malaria endemicities
timeFrame: At month 8 of implementation
Other outcomes:
measure: Proportion of school children with malnutrition
timeFrame: at month 0 (baseline) and at month 12.
Locations:
city: Tanga
country: Tanzania
facility: Handeni Town Council, Handeni and Kilindi Districts
Study officials:
affiliation: National Institute for Medical Research, Tanga, Tanzania
name: John P.A Lusingu, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Malaria Control Programme, Tanzania
name: Ally Mohamed, MD
role: STUDY_DIRECTOR
affiliation: National Institute for Medical Research, Tanzania
name: Geofrey Makenga, MD, Msc, PhD fellow
role: PRINCIPAL_INVESTIGATOR
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