Feasibility, Acceptability, and Protective Efficacy of Seasonal Malaria Chemoprevention Implementation in Nampula Province, Mozambique: Protocol for a Hybrid Effectiveness-Implementation Study

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 the global malaria cases, and malaria is responsible for one-quarter of all deaths in the country. Based on recommendations in the Malaria Strategic Plan, the Malaria Consortium, in partnership with the National Malaria Control Programme in Mozambique, initiated a phased SMC implementation study in the northern province of Nampula. The first phase of this 2-year implementation study was conducted in 2020-2021 and focused on the feasibility and acceptability of SMC. The second phase will focus on demonstrating impact. This paper describes phase 2 of the implementation study. Objective Specific objectives include the following: (1) to determine the effectiveness of SMC in terms of its reduction in incidence of malaria infection among children aged 3 to 59 months; (2) to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for SMC in Nampula Province, Mozambique, and the extent to which efficacy is impacted by drug resistance and drug concentrations; (3) to investigate the presence and change in SP+AQ– and piperaquine-resistance markers over time as a result of SMC implementation; and (4) to understand the impact of the SMC implementation model, determining the process and acceptability outcomes for the intervention. 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: (1) a cluster randomized controlled trial to establish confirmed malaria cases, (2) a prospective cohort to determine the chemoprevention efficacy of the antimalarials used for SMC and whether drug concentrations or resistance influence the duration of protection, (3) a resistance marker study in children aged 3 to 59 months to describe changes in resistance marker prevalence over time, and (4) a process evaluation to determine feasibility and acceptability of SMC. Results Data collection began in mid-January 2022, and data analysis is expected to be completed by October 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 of the Sahel. The chemoprevention efficacy cohort study is a unique opportunity to better understand SMC drug efficacy in this new SMC environment. Trial Registration ClinicalTrials.gov NCT05186363; https://clinicaltrials.gov/ct2/show/NCT05186363 International Registered Report Identifier (IRRID) DERR1-10.2196/36403

Malaria trends in districts that were targeted and not-targeted for seasonal malaria chemoprevention in children under 5 years of age in Guinea, 2014–2021

“…Because SMC is consistently proving to be a high coverage and effective intervention, several countries with seasonal malaria transmission outside of the Sahel are now piloting SMC to be included in their malaria intervention package (eg, Uganda 44 and Mozambique 45 ). WHO recently amended the SMC guidelines to give countries flexibility to change the SMC regimen (eg, by adding additional SMC cycles to cover longer peak transmission seasons, or by including older age groups).…”

Field testing of user-friendly perennial malaria chemoprevention packaging in Benin, Côte d’Ivoire and Mozambique

“…The primary level health system consists of health posts, health centres and rural hospitals. Mozambique has implemented IPTp and began SMC implementation in 2020 [ 31 ].…”

A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda

“…This type 2 hybrid effectiveness-implementation study uses a convergent mixed-methods approach, as previously described in other similar studies conducted by our group 21,22 . SMC with SPAQ and DP will be implemented in five monthly cycles between June 2022 and October 2022 in five districts of Karamoja.…”