Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania

NCT ID: NCT05874869

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-30

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.

Conditions

Malaria; Chemoprophylaxis; Underfive Children

Study Design

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

Study Groups

Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine will be administered to the intervention arm

Group Type: ACTIVE_COMPARATOR

Dihydroartemisinin-piperaquine

Intervention Type: DRUG

The drug will be administered once a day for three consecutive days for three months (March, April, and May)

Control

Individuals that will get malaria infection and present at the health facility with clinical signs and symptoms will be treated according to the Tanzania National Malaria Treatment guidelines using artemether-lumefantrine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dihydroartemisinin-piperaquine

The drug will be administered once a day for three consecutive days for three months (March, April, and May)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: collaborator

Hubert Kairuki Memorial University

OTHER

Sponsor Role: collaborator

Richard Mwaiswelo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Richard Mwaiswelo

Co-Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Muhimbili University of Health and Allied Ssciences

Dar es Salaam, , Tanzania

Countries

Tanzania

References

Mwaiswelo R, Ngasala B, Chaky F, Molteni F, Mohamed A, Lazaro S, Samwel B, Mmbando BP. Dihydroartemisinin-piperaquine effectiveness for seasonal malaria chemoprevention in settings with extended seasonal malaria transmission in Tanzania. Sci Rep. 2024 Jan 25;14(1):2143. doi: 10.1038/s41598-024-52706-z.

Reference Type: DERIVED

PMID: 38273019 (View on PubMed)

Other Identifiers

MUHAS-REC-10-2019-062

Identifier Type: -

Identifier Source: org_study_id