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Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

Mass Drug Administration With Dihydroartemisinin-piperaquine and Primaquine to Reduce Malaria in a Moderate-low Transmission Setting in Senegal: A Cluster Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04864444
Enrollment
10715
Registered
2021-04-28
Start date
2021-06-19
Completion date
2023-06-30
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Malaria,Falciparum

Keywords

Antimalarials, Mass drug administration, Dihydroartemsinin, Piperaquine, Primaquine, Parasitic Diseases

Brief summary

This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).

Detailed description

Over the past two decades in Senegal, the scale-up of malaria control measures \[e.g., access to prompt testing and case management, LLINs, and SMC\] has led to a 78% reduction in malaria incidence. However, gains have not been uniform, with lower transmission areas in the north implementing pre-elimination activities and higher transmission areas in the south implementing control interventions (including SMC). The purpose of this study is determine whether MDA will be able to rapidly reduce malaria incidence in areas of moderate-to-low malaria transmission of southern Senegal (where control activities are ongoing) so that the program can reorient their malaria strategy to implement elimination interventions in these settings. The study aims to deliver three rounds of community-wide MDA with DHA-PPQ + SLD-PQ. MDA drugs will be administered over the course of three days. All three doses of DHA-PPQ will be given via supervised DOT (as per administration of SMC by national malaria guidelines) through a door-to-door approach. The research objectives are: 1. To evaluate the impact of three rounds of MDA with DHA-PPQ and SLD-PQ on village-level confirmed malaria case incidence, malaria prevalence, and on reaching a target malaria incidence of \<5 cases per 1000 person-years compared to standard-of-care SMC when provided in the context of optimized control (proactive community case management + PBO LLINs). 2. To determine the cost, coverage, operational feasibility, and acceptability of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC. 3. To determine the impact of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC on parasite population dynamics and drug resistance.

Interventions

DRUGDihydroartemisinin-piperaquine

DHA-PPQ will be given over the course of three consecutive days using 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets. DHA-PPQ will be administered via age-based dosing. All three doses will be directly observed and given orally with water and without food.

DRUGPrimaquine

Primaquine will be given once with the first dose of DHA-PPQ. Primaquine will be administered in an aqueous solution according to age-based dosing guidelines.

Sponsors

L'université de Thiès
CollaboratorOTHER
Programme National de Lutte contre le Paludisme (PNLP), Senegal
CollaboratorUNKNOWN
Population Services International
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
US President's Malaria Initiative
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This is a two-arm cluster randomized controlled trial. A total of 60 villages will be randomized to receive the intervention (three rounds of MDA with DHA-PPQ + SLD-PQ) or control (standard malaria control measures, including SMC) at a ratio of 1:1

Eligibility

Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥3 months * Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study

Exclusion criteria

* Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition) * Known hypersensitivity to study drug Additional

Design outcomes

Primary

MeasureTime frameDescription
Difference in village-level confirmed incidence of malariaone year post-MDAVillage-level malaria incidence will be defined as the number of individuals diagnosed with malaria through proactive case detection and passive malaria surveillance at the health facility-level over the total village population measured during census.

Secondary

MeasureTime frameDescription
Difference in parasite prevalence by microscopy during high malaria transmission season3 months after last round of MDAParasite prevalence will be assessed via microscopy from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Difference in parasite prevalence by polymerase chain reaction (PCR) during high malaria transmission season3 months after last round of MDAParasite prevalence will be assessed via polymerase chain reaction from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Difference in serological markers of recent infection3 months after last round of MDADifference in seroprevalence from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Difference in the change in prevalence of drug resistance markersChange from baseline to endline; 1 year periodPrevalence of drug resistance markers (K13 and plasmepsin copy number) will be assessed from samples taken during the baseline and endline cross-sectional surveys.
Difference in the change in prevalence of parasite population dynamicsChange from baseline to endline; 1 year periodPrevalence of parasite population dynamics (multiplicity of infection) will be assessed from samples taken during the baseline and endline cross-sectional surveys.

Other

MeasureTime frameDescription
Population coverage of MDAUp to 18 weeksCoverage will be measured as the proportion of people who received MDA divided by the total number of persons in the population at each MDA round.
Difference in the cost-effectiveness of MDA versus SMCUp to 24 monthsCosts of MDA and optimized control will be collected throughout the study period. The incremental cost-effectiveness ratio (ICER) will be used to compare MDA to SMC.

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026