MalariaPhase 4IPTscNCT04245033
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
A Phase 4 study testing Dihydroartemisinin-Piperaquine (DP) in people with Malaria, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Dihydroartemisinin-Piperaquine (DP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,100 participants
- Where
- 1 siteTanzania
- Study dates
- 20 Jul 2020to 28 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Includes parental/guardian informed consent
- Assent by primary school children aged 11 years and above.
- Aged 5-15 years.
- Currently, lives within the pre-defined catchment area of study district; and
- Will remain within the same area throughout the study period (preferably class five and below).
Who cannot join
- Students at class 7
- Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
- Known to have heart disease or a known cardiac ailment.
- Reports known hypersensitivity to the study drugs.
- Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol.
- Having clinical features of severe anaemia
Show all 10Show fewer
- Febrile due to non-malaria illness at the time of recruitment.
- Has apparent severe infection or any condition that requires hospitalization
- 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.
- Body weight < 12 kg
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Dihydroartemisinin-Piperaquine (DP)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-Piperaquine (DP)Drug
Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).
| Study group | Role | What they receive |
|---|---|---|
| IPTsc arm | Experimental | 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. Receives: Drug: Dihydroartemisinin-Piperaquine (DP) |
| Control | No intervention | No intervention will be given to wards randomised in this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions
Efficiency in terms of percentage of children given a complete dose in each round.
Measured: 1 year from start of intervention
Clinical malaria incidence
Malaria incidence will be collected in terms of number of episodes a child gets malaria.
Measured: from month 0 till month 12 of follow up
Secondary outcomes (5)
Change in malaria incidence per 1000 population at local health facility level
Number of malaria episodes before and after intervention in a respective ward
Measured: from month 0 till month 12 of follow up
Change from baseline in haemoglobin concentration
individual change in Haemoglobin before and after intervention
Measured: measured at month 12
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events encountered by subjects per study arm
Measured: through study completion, an average of 1 year"
Cardio safety profile by QTc prolongation from baseline
measured by ECG
Measured: Day 1, 2,3 and 7 after before and after dosing
Acceptability of IPTsc in communities with high malaria endemicities
Through in depth interview in a guided questionnaire
Measured: At month 8 of implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start20 Jul 2020
- Primary completion31 May 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 4,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- National Malaria Control Program
- Responsible party
- Principal investigator, Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania
- Investigators
- John P.A Lusingu, MD, PhD, Study director, National Institute for Medical Research, Tanga, TanzaniaAlly Mohamed, MD, Study director, National Malaria Control Programme, TanzaniaGeofrey Makenga, MD, Msc, PhD fellow, Principal investigator, National Institute for Medical Research, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245033
- Sponsor's protocol ID
- IPTsc version 1
- Acronym
- IPTsc
- Status last verified
- Nov 2024
- First submitted
- 20 Jan 2020
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Makenga G, Mmbando B, Seth MD, Baraka V, Challe DP, Francis F, Mhina AD, Liheluka E, Minja DTR, Chiduo M, Mtove G, Mandara C, Gesase S, Segeja MD, Kamugisha M, Hayuma PM, Mbwana JR, Sebukoto H, Malabeja A, Tupa JB, Ngede SJ, Lusasi A, Chacky F, David A, Thawer SG, Mohamed A, Aaron S, Lazaro S, Molteni F, Nkayamba A, Bastiaens H, Van Geertruyden JP, Lusingu JPA. Implementation and effectiveness of intermittent preventive treatment in school aged children using dihydroartemisinin-piperaquine to reduce malaria burden: an implementation research of a cluster randomised trial in Tanzania. EClinicalMedicine. 2025 Nov 7;90:103628. doi: 10.1016/j.eclinm.2025.103628. eCollection 2025 Dec.
PubMed 41278241Makenga 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.
PubMed 36609279
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04245033
- Acronym / sponsor ID
- IPTsc / IPTsc version 1
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,100 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- National Malaria Control Program
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| IPTsc arm | Experimental | Drug: Dihydroartemisinin-Piperaquine (DP)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. |
| Control | No intervention | –No intervention will be given to wards randomised in this arm |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Includes parental/guardian informed consent
- Assent by primary school children aged 11 years and above.
- Aged 5-15 years.
- Currently, lives within the pre-defined catchment area of study district; and
- Will remain within the same area throughout the study period (preferably class five and below).
Key exclusion criteria (10 listed)
- Students at class 7
- Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
- Known to have heart disease or a known cardiac ailment.
- Reports known hypersensitivity to the study drugs.
- Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroartemisinin-Piperaquine (DP)Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc). | Drug | IPTsc arm |
Primary outcome
Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions
Time frame: 1 year from start of intervention
Efficiency in terms of percentage of children given a complete dose in each round.
Clinical malaria incidence
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.
5 secondary outcomes
Change in malaria incidence per 1000 population at local health facility level
Time frame: from month 0 till month 12 of follow up
Change from baseline in haemoglobin concentration
Time frame: measured at month 12
Number of participants with treatment-related adverse events
Time frame: through study completion, an average of 1 year"
Cardio safety profile by QTc prolongation from baseline
Time frame: Day 1, 2,3 and 7 after before and after dosing
Acceptability of IPTsc in communities with high malaria endemicities
Time frame: At month 8 of implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 41278241Makenga G, Mmbando B, Seth MD, Baraka V, Challe DP, Francis F, Mhina AD, Liheluka E, Minja DTR, Chiduo M, Mtove G, Mandara C, Gesase S, Segeja MD, Kamugisha M, Hayuma PM, Mbwana JR, Sebukoto H, Malabeja A, Tupa JB, Ngede SJ, Lusasi A, Chacky F, David A, Thawer SG, Mohamed A, Aaron S, Lazaro S, Molteni F, Nkayamba A, Bastiaens H, Van Geertruyden JP, Lusingu JPA. Implementation and effectiveness of intermittent preventive treatment in school aged children using dihydroartemisinin-piperaquine to reduce malaria burden: an implementation research of a cluster randomised trial in Tanzania. EClinicalMedicine. 2025 Nov 7;90:103628. doi: 10.1016/j.eclinm.2025.103628. eCollection 2025 Dec.
- Derived from this study: PubMed 36609279Makenga 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P.A Lusingu, MD, PhD study director
National Institute for Medical Research, Tanga, Tanzania
Ally Mohamed, MD study director
National Malaria Control Programme, Tanzania
Geofrey Makenga, MD, Msc, PhD fellow principal investigator
National Institute for Medical Research, Tanzania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydroartemisinin-Piperaquine (DP) in people with Malaria, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions (time frame: 1 year from start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245033, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.