Baker Kevin, Pulido Tarquino Ivan Alejandro, Aide Pedro, Bonnington Craig, Rassi Christian, Richardson Sol, Nnaji Chuks, Roca-Feltrer Arantxa, Rodrigues Maria, Sitoe Mercia, Enosse Sonia, McGugan Caitlin, Saute Francisco, Matambisso Gloria, Candrinho Baltazar
Malaria Consortium, London, UK.
Department of Global Public Health, Karolinska Institute, Stockholm, Sweden.
Malar J. 2025 Feb 21;24(1):56. doi: 10.1186/s12936-024-05229-x.
Seasonal malaria chemoprevention (SMC) is a highly effective intervention for malaria prevention in high burden areas with seasonal transmission, historically implemented in the Sahel. Mozambique contributes to 4% of global malaria cases. Malaria Consortium, in partnership with the National Malaria Control Programme, conducted a two-year phased SMC study in Nampula province using sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ), or SPAQ, in children under five. Phase one results presented here highlight acceptability, feasibility, and protective effect of SMC.
A pragmatic type II hybrid effectiveness-implementation study design was adopted, using mixed methods. The study was conducted in three districts, utilizing: (1) non-randomized controlled trial reporting on malaria incidence; (2) drug resistance molecular marker study reporting on resistance marker changes over time; (3) coverage and quality assessment on the SMC distribution; and (4) a qualitative acceptability and feasibility assessment with stakeholders.
Children who received SMC had 86% (hazard ratio 0.14, 95% CI 0.09-0.24) lower hazards of developing clinical malaria during the peak transmission season compared with children in the comparison district. Prevalence of SP molecular markers associated with resistance was high at baseline (K540E 66.1%). SMC achieved high coverage of eligible children over four cycles (87.7%, 95% CI 83.9-90.8%). Qualitative results indicate SMC was positively accepted by the targeted community.
Results suggest that SMC was effective at preventing clinical malaria, did not significantly impact resistance profile, and was feasible and acceptable in the context. Phase two will assess SMC impact in reducing malaria incidence and if chemoprevention efficacy of SPAQ is impacted by drug resistance and drug concentrations.
季节性疟疾化学预防(SMC)是在季节性传播的高负担地区预防疟疾的一种高效干预措施,历史上在萨赫勒地区实施。莫桑比克的疟疾病例占全球的4%。疟疾防治联盟与国家疟疾控制规划合作,在楠普拉省对5岁以下儿童开展了一项为期两年的分阶段SMC研究,使用周效磺胺-乙胺嘧啶(SP)加阿莫地喹(AQ),即SPAQ。此处呈现的第一阶段结果突出了SMC的可接受性、可行性和保护效果。
采用实用型II类混合有效性-实施研究设计,运用混合方法。该研究在三个地区开展,利用:(1)关于疟疾发病率的非随机对照试验报告;(2)关于耐药性标志物随时间变化的耐药分子标志物研究报告;(3)SMC分发的覆盖范围和质量评估;以及(4)与利益相关者进行的定性可接受性和可行性评估。
与对照区的儿童相比,接受SMC的儿童在传播高峰期发生临床疟疾的风险降低了86%(风险比0.14,95%置信区间0.09 - 0.24)。与耐药相关的SP分子标志物在基线时的流行率很高(K540E为66.1%)。SMC在四个周期内实现了对符合条件儿童的高覆盖率(87.7%,95%置信区间83.9 - 90.8%)。定性结果表明,目标社区对SMC持积极接受态度。
结果表明,SMC在预防临床疟疾方面有效,对耐药情况没有显著影响,并且在该环境下是可行且可接受的。第二阶段将评估SMC在降低疟疾发病率方面的影响,以及SPAQ的化学预防效果是否受到耐药性和药物浓度的影响。