Effectiveness of seasonal malaria chemoprevention at scale in west and central Africa: an observational study.
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SUBMITTER: ACCESS-SMC Partnership
PROVIDER: S-EPMC7718580 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
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Effectiveness of seasonal malaria chemoprevention at scale in west and central Africa: an observational study.
Lancet (London, England) 20201201 10265
<h4>Background</h4>Seasonal malaria chemoprevention (SMC) aims to prevent malaria in children during the high malaria transmission season. The Achieving Catalytic Expansion of SMC in the Sahel (ACCESS-SMC) project sought to remove barriers to the scale-up of SMC in seven countries in 2015 and 2016. We evaluated the project, including coverage, effectiveness of the intervention, safety, feasibility, drug resistance, and cost-effectiveness.<h4>Methods</h4>For this observational study, we collected ...[more]
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Project description:Effectiveness of dihydroartemisinin-piperaquine (DP) as seasonal malaria chemoprevention (SMC) was assessed in Nanyumbu and Masasi Districts. Between March and June 2021, children aged 3-59 months were enrolled in a cluster randomized study. Children in the intervention clusters received a monthly, 3-days course of DP for three consecutive months regardless of malaria infection status, and those in the control clusters received no intervention. Malaria infection was assessed at before the first-round and at 7 weeks after the third-round of DP in both arms. Malaria prevalence after the third-round of DP administration was the primary outcome. Chi-square tests and logistic regression model were used to compare proportions and adjust for explanatory variables. Before the intervention, malaria prevalence was 13.7% (161/1171) and 18.2% (212/1169) in the intervention and control clusters, respectively, p < 004. Malaria prevalence declined to 5.8% (60/1036) in the intervention clusters after three rounds of DP, and in the control clusters it declined to 9.3% (97/1048), p = 0.003. Unadjusted and adjusted prevalence ratios between the intervention and control arms were 0.42 (95%CI 0.32-0.55, p < 0.001) and 0.77 (95%CI 0.53-1.13, p = 0.189), respectively. SMC using DP was effective for control of malaria in the two Districts.Trial registration: NCT05874869, https://clinicaltrials.gov/ 25/05/2023.
| S-EPMC10810795 | biostudies-literature
Project description:BackgroundSeasonal malaria chemoprevention (SMC) has shown high protective efficacy against clinical malaria and severe malaria in a series of clinical trials. We evaluated the effectiveness of SMC treatments against clinical malaria when delivered at scale through national malaria control programmes in 2015 and 2016.Methods and findingsCase-control studies were carried out in Mali and The Gambia in 2015, and in Burkina Faso, Chad, Mali, Nigeria, and The Gambia in 2016. Children aged 3-59 months presenting at selected health facilities with microscopically confirmed clinical malaria were recruited as cases. Two controls per case were recruited concurrently (on or shortly after the day the case was detected) from the neighbourhood in which the case lived. The primary exposure was the time since the most recent course of SMC treatment, determined from SMC recipient cards, caregiver recall, and administrative records. Conditional logistic regression was used to estimate the odds ratio (OR) associated with receipt of SMC within the previous 28 days, and SMC 29 to 42 days ago, compared with no SMC in the past 42 days. These ORs, which are equivalent to incidence rate ratios, were used to calculate the percentage reduction in clinical malaria incidence in the corresponding time periods. Results from individual countries were pooled in a random-effects meta-analysis. In total, 2,126 cases and 4,252 controls were included in the analysis. Across the 7 studies, the mean age ranged from 1.7 to 2.4 years and from 2.1 to 2.8 years among controls and cases, respectively; 42.2%-50.9% and 38.9%-46.9% of controls and cases, respectively, were male. In all 7 individual case-control studies, a high degree of personal protection from SMC against clinical malaria was observed, ranging from 73% in Mali in 2016 to 98% in Mali in 2015. The overall OR for SMC within 28 days was 0.12 (95% CI: 0.06, 0.21; p < 0.001), indicating a protective effectiveness of 88% (95% CI: 79%, 94%). Effectiveness against clinical malaria for SMC 29-42 days ago was 61% (95% CI: 47%, 72%). Similar results were obtained when the analysis was restricted to cases with parasite density in excess of 5,000 parasites per microlitre: Protective effectiveness 90% (95% CI: 79%, 96%; P<0.001), and 59% (95% CI: 34%, 74%; P<0.001) for SMC 0-28 days and 29-42 days ago, respectively. Potential limitations include the possibility of residual confounding due to an association between exposure to malaria and access to SMC, or differences in access to SMC between patients attending a clinic and community controls; however, neighbourhood matching of cases and controls, and covariate adjustment, attempted to control for these aspects, and the observed decline in protection over time, consistent with expected trends, argues against a major bias from these sources.ConclusionsSMC administered as part of routine national malaria control activities provided a very high level of personal protection against clinical malaria over 28 days post-treatment, similar to the efficacy observed in clinical trials. The case-control design used in this study can be used at intervals to ensure SMC treatments remain effective.
| S-EPMC8457484 | biostudies-literature
Project description:BackgroundThe World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SPAQ) for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist.ObjectiveThe study aims to test the effectiveness of SMC with Dihydroartemisinin-piperaquine (DP) or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal.MethodsA Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to <6 months; 3) a resistance markers study in children 3-59 months in the research districts plus the standard intervention districts to measure changes in resistance marker prevalence over time and finally; 4) a process evaluation.DiscussionThis study evaluates the effects of SPAQ-SMC versus DP-SMC on clinical malaria in vulnerable children in the context of high parasite SP resistance, whilst informing on the best implementation strategies.ConclusionThis study will inform malaria policy in high-burden countries, specifically on utility of SMC outside the sahel, and contribute to progress in malaria control.
| S-EPMC10774186 | biostudies-literature
Project description:ObjectiveTo assess the effectiveness of seasonal malaria chemoprevention (SMC) in reducing under-five malaria morbidity and mortality.DesignUnder-five malaria data for confirmed episodes, deaths, and number of children dosed per cycle of SMC campaign were extracted from the District Health Information Management System (DHIMS-2) for 2018-2019. Data verification was done to compare extracted data with the source for completeness and consistency. Association between SMC and the main outcome variables (malaria cases and mortality) was computed from 2X2 tables and reported as rate ratios at a 95% confidence level.SettingAll seven (7) districts in Savannah Region, Ghana.ParticipantsChildren under five years.InterventionSulphadoxine-Pyrimethamine and Amodiaquine (SPAQ) prophylaxis given monthly, four times, durng the rainy season (July to October).Main outcome measuresSMC coverage per cycle and under-five malaria morbidity and mortality ratios.ResultsOver 370,000 dose packs of SPAQ were administered with an average cycle coverage of 93%. There was approximately 17% (p<0.01) and 67% (p=0.047) reduction in malaria-related morbidity and mortality, respectively, in the implementation year compared with the baseline. This translated into nearly 9,300 episodes of all forms of malaria and nine malaria-attributable deaths averted by the intervention.ConclusionSMC (combined with existing control measures) wields prospects of accelerating the regional/national malaria elimination efforts if the implementation is optimised. Expansion of the intervention to other high-prevalence regions with seasonal variation in disease burden may be worthwhile.FundingNone declared.
| S-EPMC10336463 | biostudies-literature
Project description:Seasonal Malaria Chemoprevention (SMC) is recommended for children under 5 in the Sahel and sub-Sahel. The burden in older children may justify extending the age range, as has been done effectively in Senegal. We examine costs of door-to-door SMC delivery to children up to 10 years by community health workers (CHWs). We analysed incremental financial and economic costs at district level and below from a health service perspective. We examined project accounts and prospectively collected data from 405 CHWs, 46 health posts, and 4 district headquarters by introducing questionnaires in advance and completing them after each monthly implementation round. Affordability was explored by comparing financial costs of SMC to relevant existing health expenditure levels. Costs were disaggregated by administration month and by health service level. We used linear regression models to identify factors associated with cost variation between health posts. The financial cost to administer SMC to 180 000 children over one malaria season, reaching ∼93% of children with all three intended courses of SMC was $234 549 (constant 2010 USD) or $0.50 per monthly course administered. Excluding research-participation incentives, the financial cost was $0.32 per resident (all ages) in the catchment area, which is 1.2% of Senegal's general government expenditure on health per capita. Economic costs were 18.7% higher than financial costs at $278 922 or $0.59 per course administered and varied widely between health posts, from $0.38 to $2.74 per course administered. Substantial economies of scale across health posts were found, with the smallest health posts incurring highest average costs per monthly course administered. SMC for children up to 10 is likely to be affordable, particularly where it averts substantial curative care costs. Estimates of likely costs and cost-effectiveness of SMC in other contexts must account for variation in average costs across delivery months and health posts.
| S-EPMC5886061 | biostudies-literature
Project description:BackgroundSeasonal Malaria Chemoprevention (SMC) is a highly effective intervention for preventing malaria, particularly in areas with highly seasonal transmission. Monitoring and evaluating (M&E) SMC programmes are complex due to the scale, time-sensitive delivery of the programme, and influence of external factors. This paper describes the process followed to develop a comprehensive M&E framework tailored specifically for the SMC context.MethodsThe Framework was developed through a literature and programme review, and stakeholder dialogues across three implementing countries-Burkina Faso, Chad, and Nigeria. Expert consultation further refined the Framework through an iterative approach drawing upon data collected through the three sources. The Framework was designed using the Logical Framework Approach incorporating external factors and intentionally aligned with global malaria M&E standards.ResultsAn overall aim and seven programme objectives were developed measured by 70 indicators. The indicators also capture the causal links between the implementation and results of the programme. The Framework leverages the use of current data sources and existing mechanisms, ensuring efficient data use without requiring a significant increase in resources for overall programme optimization. It also promotes the use of data triangulation, and stratification for a more nuanced understanding of factors affecting programme performance and timely data informed decision-making.ConclusionsThe SMC M&E Framework presented here provides a standardized approach for programme implementers to enhance decision-making for optimal programme performance. This is an essential tool as the scope of SMC programmes expands to new geographies and target age groups.
| S-EPMC10837904 | biostudies-literature
Project description:Seasonal malaria chemoprevention (SMC) for children under 5 years of age for up to four monthly cycles during malaria transmission season was recommended by the WHO in 2012 and has been implemented in 13 countries in the Sahel, reaching more than 30 million children annually. Malaria control programs implementing SMC have asked the WHO to consider expanding the age range or number of monthly cycles. We conducted a systematic review and meta-analysis of SMC among children up to 15 years of age and up to six monthly cycles. Twelve randomized studies were included, with outcomes stratified by age (< 5/≥ 5 years), by three or four versus five or six cycles, and by drug where possible. Drug regimens included sulfadoxine-pyrimethamine + amodiaquine, amodiaquine-artesunate, and sulfadoxine-pyrimethamine + artesunate. Included studies were all conducted in Sahelian countries in which high-grade resistance to sulfadoxine-pyrimethamine was rare and in zones with parasite prevalence ranging from 1% to 79%. Seasonal malaria chemoprevention resulted in substantial reductions in uncomplicated malaria incidence measured during that transmission season (rate ratio: 0.27, 95% CI: 0.25-0.29 among children < 5 years; rate ratio: 0.27, 95% CI: 0.25-0.30 among children ≥ 5 years) and in the prevalence of malaria parasitemia measured within 4-6 weeks from the final SMC cycle (risk ratio: 0.38, 95% CI: 0.34-0.43 among children < 5 years; risk ratio: 0.23, 95% CI: 0.11-0.48 among children ≥ 5 years). In high-transmission zones, SMC resulted in a moderately reduced risk of any anemia (risk ratio: 0.77, 95% CI: 0.72-0.83 among children < 5 years; risk ratio: 0.70, 95% CI: 0.52-0.95 among children ≥ 5 years [one study]). Children < 10 years of age had a moderate reduction in severe malaria (risk ratio: 0.53, 95% CI: 0.37-0.76) but no evidence of a mortality reduction. The evidence suggests that in areas in which sulfadoxine-pyrimethamine and amodiaquine remained efficacious, SMC effectively reduced malaria disease burden among children both < 5 and ≥ 5 years old and that the number of cycles should be commensurate with the length of the transmission season, up to six cycles.
| S-EPMC10793029 | biostudies-literature
Project description:BackgroundMalaria remains a major public health problem, especially in sub-Sahara African countries. The Malaria Control Program of Ghana has implemented Seasonal Malaria Chemoprevention (SMC) intervention in the Upper West Region in 2015. This preventive drug has been recommended by WHO as very safe and effective in preventing malaria in children under five years. This study assessed community acceptability of the SMC intervention in the Lawra district of Northern Ghana.MethodologyThis was a qualitative study where focus group discussions and in-depth interviews were conducted with community-based health volunteers and parents whose children received the SMC drug. Purposive sampling method was used to select study participants. The interviews were recorded with consent of study participants. All interviews were transcribed and coded into emergent themes using Nvivo 10 software before thematic content analysis.ResultsStudy participants perceived that the introduction of the SMC intervention in the area had helped to reduce the prevalence of malaria among children less than five years of age. Parents held the view that the drug was very good in preventing malaria. The results also showed high acceptability of the SMC intervention by parents and other community members. Parents reported that they were willing to allow their children to receive the drug and wished the intervention could continue in the district for children to continue to benefit. Nonetheless, negative attitude on the part of few parents made them not to allow their children to receive the drug.ConclusionThe interpretation of our data showed high acceptability of the SMC by stakeholders in the study area. However, intensive and continued health education on the benefits of the SMC drug could help to further improve acceptability of the program.
| S-EPMC6524792 | biostudies-literature
Project description:BackgroundSeasonal 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.ObjectiveSpecific 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.MethodsThis 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.ResultsData collection began in mid-January 2022, and data analysis is expected to be completed by October 2022.ConclusionsThis 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 registrationClinicalTrials.gov NCT05186363; https://clinicaltrials.gov/ct2/show/NCT05186363.International registered report identifier (irrid)DERR1-10.2196/36403.
| S-EPMC9547334 | biostudies-literature
Project description:BackgroundImplemented in 17 countries to date, seasonal malaria chemoprevention (SMC) is a recommended strategy to prevent childhood malaria in areas with seasonal transmission of P. falciparum through monthly administration of antimalarial medicines. Understanding the costs and resource requirements of SMC delivery is necessary for effective planning and resource allocation. This systematic literature review aims to assess the evidence on the cost and cost-effectiveness of SMC delivery.MethodsFollowing PRISMA guidelines, five databases were systematically reviewed to identify evidence on SMC costs and cost-effectiveness published between 2012 and 2023. Studies with defined costing methodologies and cost output measures were included, excluding those relying solely on mathematical modeling. Two reviewers assessed each study for eligibility and extracted cost data, which were adjusted for inflation. Quality assessment was completed using the CHEERS checklist.ResultsSix costing studies were identified spanning nine countries. Four studies examined costs during an SMC pilot or introduction, one during scale-up, and one costed newly established SMC campaigns through a multi-country project. Costs were examined at country level with the financial costs per child receiving a full course of SMC ranging from $1.71 to $12.46, while economic costs per child ranged from $2.11 to $29.06. Four studies included a cost effectiveness analysis with incremental cost-effectiveness ratios (ICERs) per clinical malaria case averted ranging from $5.41 to $138.03; ICER per disability-adjusted life year (DALY) averted from $24.51 to $182.88; and ICER per death averted from $688.86 to $18,418.81. Differences in cost estimates stemmed from different factors including variations in cost ingredients, scale of the intervention, and study perspectives.DiscussionThe level of detail for reporting SMC costs and cost categories varied greatly by study as did the scale of intervention, limiting comparability as well as an understanding of the complete costs and resource requirements for SMC implementation. Cost evidence is not from mature programs but from pilots or relatively new campaigns. Costs incurred by households and costs of the integrated delivery of SMC with other health interventions were often overlooked. Adopting a standardized costing approach for mature SMC programmes could provide a better understanding of resource requirements and costs while enhancing study comparability across settings, better informing future resource allocation and improving efficiency.
| S-EPMC11657606 | biostudies-literature