A protocol for a hybrid effectiveness-implementation study to assess the feasibility, acceptability and protective efficacy of implementing seasonal malaria chemoprevention in Nampula province, Mozambique (Preprint)

Abstract

BACKGROUND Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections in areas where the malaria burden is high and transmission occurs mainly during the rainy season. In Africa, so far, SMC has been implemented in the Sahel region. Mozambique contributes 4% of global malaria cases, and malaria represents one out first four causes of death in the country. Based on recommendations in the Malaria Strategic Plan, Malaria Consortium, in partnership with the Mozambican National Malaria Control Program (NMCP), initiated a phased SMC implementation study in the northern province of Nampula. It is as a two-year implementation study, with the first phase, conducted in 2020-2021, focusing on the feasibility and acceptability of SMC and the second phase on demonstrating impact. This paper describes phase 2 of the implementation study. OBJECTIVE Thsi study aims to test the feasibility, effectiveness and chemopreventive efficacy of SMC with SPAQ in a province of Mozambique, Nampula, where malaria transmission is highly seasonal. METHODS This type 2 hybrid effectiveness-implementation study uses a convergent mixed-methods approach. SMC will be implemented in four monthly cycles between December 2021 and March 2022 in four districts of Nampula province. Phase 2 will include four components: a cluster randomized control trial (cRCT) to establish confirmed malaria cases, a prospective cohort to determine whether SPAQ provides 28 days of protection from infection, and whether drug concentrations and/or resistance influence the duration of protection, a resistance markers study in children aged 3–59 months to describe changes in resistance marker prevalence over time. Finally, a process evaluation will determine feasibility and acceptability of SMC. RESULTS Ethical approval was granted by Comité Nacional de Bioética para a Saùde (CNBS) of MoH of Mozambique (Ref: 803/CNBS/21) and by Research Ethics Committee of the Hospital Clinic of Barcelona (Ref: HCB/2021/0944). Data collection begins in mid-January 2022, and data analysis is expected to be completed by August 2022. CONCLUSIONS This is the first effectiveness trial of SMC implemented in Mozambique. The findings from this trial will be crucial to policy change and program expansion to other suitable geographies outside the Sahel. The chemoprevention efficacy cohort study is a unique opportunity to better understand SMC drug efficacy in this new SMC environment. CLINICALTRIAL The trial has been registered on clinicaltrials.gov (Ref: NCT05186363).