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Last Updated: 22/07/2024

Effectiveness, feasibility and acceptability of seasonal malaria chemoprevention in Aweil South district in Northern Bahr el Gazal, South Sudan: a type 2 hybrid effectiveness-implementation study using a convergent mixed-methods approach

Objectives

This study aims to explore whether seasonal malaria chemoprevention (SMC) is an effective intervention in the context of Northen Bahr el Gazal state, South Sudan. It also aims to assess the protective efficacy of the antimalarials used in SMC in the target population and investigate levels of parasite resistance in the study districts. If successful, this trial should provide the evidence for SMC to be included in malaria programming and policy in South Sudan. 

The specific aims are:

  1. To determine the effectiveness of SMC in terms of its impact on malaria incidence among children aged 3–59 months . 

  1. To determine chemoprevention efficacy of SPAQ when used for SMC in Northern Bahr el Gazal province, South Sudan, and the extent to which efficacy is impacted by drug resistance and drug concentrations . 

  1. To track the presence and change of SPAQ  resistance markers over time as a result of SMC implementation.  

  1.  To explore the potential scalability of SMC within other states of South Sudan. 

  2. To understand the feasibility and acceptability of implementing SMC in South Sudan. 

Principal Institution

Malaria Consortium, United Kingdom

Principal Investigators / Focal Persons

Ahmed Ismail Julla

Rationale and Abstract

To prevent malaria among those most vulnerable to the disease in areas where malaria transmission is seasonal, the World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC). SMC involves the administration of four monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) [SPAQ] to children between 3 and 59 months during the rainy season. Each full course of SPAQ confers protection from malaria for approximately 28 days. This intervention has shown to be 75% effective in preventing uncomplicated and severe malaria in children under five during this high-risk period (Baba et al 2020). Because resistance to SP is widespread in East and Southern Africa, SMC has so far only been implemented across the Sahel region of West and Central Africa. However, it has been suggested that SP may retain its effectiveness even in areas where resistance is high (>90%), i.e. where one or more resistance markers in samples of circulating malaria parasites are present. There is therefore a need to test the feasibility and effectiveness of SMC, as well as the protective efficacy of SPAQ, in areas in Eastern and Southern Africa where malaria transmission is seasonal. In South Sudan, childhood mortality has stagnated at 96/1,000 live births since 2016. Malaria is the leading cause of mortality and morbidity, responsible for 40% of hospital consultations and admissions, 33.9% of hospital deaths and 25% of deaths in children under five. Malaria incidence is estimated at 239/1,000 hospital consultations and is estimated to have doubled in rate since 2015 due to conflict, poverty, malnutrition and climate change. Bednet use is low at just 28% due to limited distribution and challenges of maintenance during movement and displacement.

Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

ClinicalTrials.gov Identifier: NCT05471544

Date

Jun 2022 — Dec 2023

Total Project Funding

$150,000

Funding Details
GiveWell, United States

Philanthropic donations by GiveWell
Project Site

South Sudan

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