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

NCT ID: NCT04245033

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-06-28

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IPTsc arm

Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment in school children (IPTsc) will be given in all wards in the IPTsc arm at an interval of four months, three times a year.

Group Type: EXPERIMENTAL

Dihydroartemisinin-Piperaquine (DP)

Intervention Type: DRUG

Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).

Control

No intervention will be given to wards randomised in this arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dihydroartemisinin-Piperaquine (DP)

Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Malaria Control Program, Tanzania

UNKNOWN

Sponsor Role: collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Geofrey Makenga

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John P.A Lusingu, MD, PhD

Role: STUDY_DIRECTOR

National Institute for Medical Research, Tanga, Tanzania

Ally Mohamed, MD

Role: STUDY_DIRECTOR

National Malaria Control Programme, Tanzania

Geofrey Makenga, MD, Msc, PhD fellow

Role: PRINCIPAL_INVESTIGATOR

National Institute for Medical Research, Tanzania

Locations

Handeni Town Council, Handeni and Kilindi Districts

Tanga, , Tanzania

Countries

Tanzania

References

Makenga G, Seth MD, Baraka V, Mmbando BP, Challe DP, Francis F, Mhina A, Minja DTR, Chiduo M, Mandara C, Liheluka E, Gesase S, Segeja M, Mtove G, Kamugisha M, Lusasi A, Chacky F, David A, Thawer S, Mohamed A, Lazaro S, Molteni F, Nkayamba A, Van Geertruyden JP, Lusingu JPA. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation. Malar J. 2023 Jan 6;22(1):7. doi: 10.1186/s12936-022-04428-8.

Reference Type: DERIVED

PMID: 36609279 (View on PubMed)

Other Identifiers

IPTsc version 1

Identifier Type: -

Identifier Source: org_study_id