Clinical trial NCT05874869: Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania
Official title: Effectiveness of Dihydroartemisinin-piperaquine as Seasonal Malaria Chemoprophylaxis in Extended High Transmission Settings of Tanzania: an Open Cluster Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Chemoprophylaxis
Underfive Children
Lead sponsor: Tropical Pesticides Research Institute, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: National Institute for Medical Research, Tanzania
name: Hubert Kairuki Memorial University
First posted: 2023-05-25
Enrollment: 13800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged \< 5 years in sub-Saharan Africa. Most of the malaria transmissions occur during the rainy season, a relatively short period. Intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. The World Health Organization has recommended seasonal malaria chemoprevention (SMC) using Sulphadoxine-pyrimethamine (SP) plus amodiaquine (AQ) in children aged 3-59 months in areas with highly seasonal malaria transmission. However, SP-AQ resistance is widespread in Tanzania. Therefore, this study will assess the effectiveness of Dihydroartemisinin-piperaquine (DHA-PQ) as SMC for the control of malaria among children in Tanzania.

Methods: Afebrile children aged 3-59 months from Nanyumbu and Masasi districts in the Mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of DHA-PQ for three or four consecutive months during the high malaria transmission season of the three consecutive years. Three approaches of DHA-PQ SMC administration will be tested; a door-to-door approach using community health workers (CHWs), outreach visits using local health facilities clinicians/nurses, and village health posts using selected CHWs. Study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. The primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees Celsius) or a history of fever in the past 24 hours and the presence of P. falciparum asexual parasitemia at any density.

Findings: The findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals.

Impact: The findings from this study will provide information on the effectiveness of DHA-PQ for seasonal prevention of malaria morbidity and mortality in children aged \< 5 years in Tanzania.


Eligibility criteria: Inclusion Criteria:

* being afebrile,
* willing to participate in the trial, and
* the ability to swallow oral medications.

Exclusion Criteria:

* a presence of an acute febrile illness or severe illness that impairs the ability to take oral medication
* HIV-positive child receiving cotrimoxazole prophylaxis,
* a child who has received a dose of antimalarial drug including dihydroartemisinin-piperaquine during the past month; and
* a history of allergy to DHA-PQ.

Primary outcomes:
measure: Prevalence of clinical malaria
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of severe malaria
timeFrame: 12 months
measure: Prevalence of malaria infection
timeFrame: 12 months
measure: Prevalence of anaemia
timeFrame: 12 months
measure: Prevalence of hospital admissions
timeFrame: 12 months
measure: Prevalence of participants with any anthropometric indices.
timeFrame: 12 months
measure: Prevalence of household heads with positive health seeking behavior
timeFrame: 12 months
measure: Prevalence of molecular markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Ssciences
Study officials:
References: