Dataset Information

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial.

ABSTRACT:

Introduction

Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis

We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination

The London School of Hygiene & Tropical Medicine's Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number

NCT05878366.

SUBMITTER: Moreno M

PROVIDER: S-EPMC10936478 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial.

Moreno Marta M Barry Aissata A Gmeiner Markus M Yaro Jean Baptist JB Sermé Samuel S SS Byrne Isabel I Ramjith Jordache J Ouedraogo Alphonse A Soulama Issiaka I Grignard Lynn L Soremekun Seyi S Koele Simon S Ter Heine Rob R Ouedraogo Amidou Z AZ Sawadogo Jean J Sanogo Edith E Ouedraogo Issa N IN Hien Denise D Sirima Sodiomon Bienvenu SB Bradley John J Bousema Teun T Drakeley Chris C Tiono Alfred B AB

BMJ open 20240312 3

<h4>Introduction</h4>Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing <i>Plasmodium falciparum</i> malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Rec ...[more]

PMID: 38479748

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Project description:BackgroundBurkina Faso implemented the seasonal malaria chemoprevention (SMC) in 2014 in seven pilot health districts, following the new recommendation by the WHO in 2012 for the prevention of the disease in children under five years old, for areas of highly seasonal malaria transmission.The objective of this study was to assess the implementation fidelity of the seasonal malaria chemoprevention strategy in one of the districts, Kaya Health District.MethodologyWe conducted a case study, with a quantitative and qualitative mixed methods. Data were collected after two campaigns of implementation of the intervention, in 2014 and 2015, through a review of specific documents of SMC intervention, and individual interview with key informants (n = 21) involved at various levels in the implementation of the strategy and a household survey with the parents (n = 284) of eligible children for the SMC strategy in 2015 in the Kaya health district. The analysis framework focused on the fidelity of the intervention's content, its coverage, and its schedule, as well as the potential moderating factors, using the model proposed by Hasson, originally from Carroll.ResultsAll components of the intervention were implemented. Villages and sectors were covered at 100%. In terms of intervention doses received, less than one-third of eligible children (32.3%) received the recommended four doses in 2015. Implementation of the strategy faced some difficulties due to insufficient training of community distributors, inadequate supply of inputs and insufficient financial resources for remuneration, advocacy and supervision, but also because of the contextual constraints due to the rainy season. Moreover, an interaction between the different moderating factors, influencing the degree of implementation of the strategy was noted.ConclusionTaking into account the moderating factors of the implementation is necessary for achieving the highest possible degree of implementation fidelity and then, reach the expected beneficial effects.

Project description:BACKGROUND:Seasonal malaria chemoprevention (SMC) relies on community health workers to distribute drugs. This study assessed: (1) the capacity of community-based distributors (CBDs) at the start and end of a campaign and from one campaign to another after training or refresher courses before each round; (2) to what extent CBDs' experience over several campaigns contributed to measurable increase in their capacities; and (3) to what extent the training and experience of committed CBDs helped the less productive to catch up. METHODS:A longitudinal analysis was conducted in one Burkina Faso health district during the 2017 and 2018 campaigns. A panel including all CBDs was created. Their capacities were observed after: (1) initial training for the 2017 season; (2) refresher training for that year's fourth round; and (3) initial training for the 2018 season. All were invited to complete a questionnaire at the end of training with 27 multiple-choice questions on their main tasks. Observers noted content coverage and conditions under which training sessions were conducted. RESULTS:The 612 CBDs showed, on average, high understanding of their tasks from the start of the annual campaigns. Tasks related to communicating with parents and reporting were best mastered. Their capacities grew from round to round and campaign to campaign, after most had undergone training and been supervised by head nurses. The greatest progress was in the technical components, considered more complex, which involved selecting eligible children, choosing the correct drug packet, and referring children to health professionals. Retaining CBDs from one round to the next benefited everyone, whatever their starting level. Groups that initially obtained the lowest scores (women, illiterates, youngest/oldest) progressed the most. CONCLUSION:These results confirm the potential of using CBDs under routine programme implementation. Mandating CBDs with targeted tasks is a functional model, as they achieve mastery in this context where investments are made in training and supervision. Losing this specificity by extending CBDs' mandates beyond SMC could have undesirable consequences. The added value of retaining committed CBDs is high. It is suggested that motivation and commitment be considered in recruitment, and that a supportive climate be created to foster retention.

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.

Project description:BackgroundSeasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.Methods and findingsThe parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014-2016). In July 2014, 19,578 children aged 3-59 months were randomised by household to study group. Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago-adjusted for age, country, and household clustering-was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.ConclusionDespite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.Trial registrationThe AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.

Dataset Information

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial.

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