Last Updated

11 Jun 2021

Mass drug administration with dihydroartemisinin-piperaquine and primaquine to reduce malaria in a moderate-low transmission setting in Senegal

Objectives

This 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 specific research objectives are:

  1. To evaluate the impact of three rounds of MDA 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.
  2. To determine the cost, coverage, operational feasibility, and acceptability of three rounds of MDA  compared to standard-of-care SMC.
  3. To determine the impact of three rounds of MDA compared to standard-of-care SMC on parasite population dynamics and drug resistance.
Rationale and Abstract

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.

Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 24000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention

Date

2021 May - 2022 Dec

Funding Details

Project Site