JMIR Publications

Background:

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum (P. falciparum) in areas where the burden of malaria is high and malaria transmission is seasonal. In 2022, the World Health Organization published new guidelines for SMC deployment which provide greater flexibility to adapt chemoprevention strategies to suit the local malaria epidemiology and context, and no longer restrict the use of SMC to the Sahel. The new guidelines also highlight the need to adopt localised approaches to malaria chemoprevention and encourages malaria programmes to assess the suitability of SMC based on the local malaria epidemiology.

Objective:

This study aims to estimate the effectiveness, chemoprevention efficacy, potential deployment impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimethamine and amodiaquine (SPAQ) in new geographies of east and southern Africa.

Methods:

The intervention in this study protocol is the administration of a single monthly cycle of SPAQ medicines to SMC-eligible children during the highest malaria transmission period. The protocol is divided into five distinct but complementary components. (1) A cluster randomized controlled trial to estimate the effectiveness of SMC with SPAQ at preventing clinical malaria during a 42-day period. The primary outcome for this component is the incidence of confirmed malaria cases using bi-weekly follow-up visits and asking caregivers if the children had been sick and tested for malaria in the preceding 2 weeks. (2) A non-randomized controlled trial to estimate the chemoprevention efficacy of SPAQ at preventing malaria infection during a 28-day period. The primary outcome for this component is chemoprevention failure, defined as a P. falciparum positive qPCR on day 28 or malaria slide positive parasites at any time from day 7. (3) A cross-sectional pre-SMC distribution prevalence study of molecular markers associated with resistance to S, P and AQ drugs, embedded in the chemoprevention efficacy component. (4) A dynamical modelling exercise to estimate the impact of SMC and where to prioritise future deployment. (5) A qualitative study employing key informant interviews and focus group discussions that will evaluate the feasibility and acceptability of the intervention among multi-level stakeholders, including caregivers and community health workers.

Results:

Rapid assessments in different geographies of east and southern Africa are expected to begin in 2023-2024. More geographies are currently being explored for the conduction of rapid assessments. Results are expected in 2024.

Conclusions:

These studies will analyse the effectiveness, chemoprevention efficacy, feasibility, acceptability, and potential impact of SMC in new east and southern African geographies. The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region.

ClinicalTrial:

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International Registered Report:

PRR1-10.2196/51774