Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

Ndiaye, Jean-Louis; Cissé, Badara; Bâ, El Hadj; Gomis, Jules F.; Ndour, C T; Molez, Jean-François; Fall, Fatou; Sokhna, Cheikh; Faye, Babacar; Kouevijdin, E.; Niane, F. K.; Cairns, Matthew; Trape, Jean‐François; Rogier, Christophe; Gaye, Oumar; Greenwood, Brian; Milligan, Paul

doi:10.1371/journal.pone.0162563

Cited by 43 publications

(41 citation statements)

References 17 publications

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“…Example 3 (Unit of delivery is individual) —“The intervention comprised a therapeutic dose of AQ (10 mg/kg/day for 3 days) combined with one dose of SP on the first day (25mg sulfamethoxypirazyne and 1.25mg pyrimethamine per kg in 2008, 25mg sulfadoxine, 1.25mg pyrimethamine in 2009–10) administered once per month for the last three months of the malaria transmission season (September-November).” 48 …”

Section: Methods: Interventionmentioning

confidence: 99%

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Hemming

Taljaard

McKenzie

et al. 2018

BMJ

287

316

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This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. We include a glossary of terms, and explore the key properties of the SW-CRT which require special consideration in their reporting.

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Section: Methods: Interventionmentioning

confidence: 99%

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Hemming

Taljaard

McKenzie

et al. 2018

BMJ

287

316

View full text Add to dashboard Cite

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“…This paper reports the study design and the results on effectiveness. The pharmacovigilance system, analysis of coverage, and the economic evaluation are reported separately [9]. …”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

et al. 2016

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BackgroundSeasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ), given each month during the transmission season, is recommended for children living in areas of the Sahel where malaria transmission is highly seasonal. The recommendation for SMC is currently limited to children under five years of age, but, in many areas of seasonal transmission, the burden in older children may justify extending this age limit. This study was done to determine the effectiveness of SMC in Senegalese children up to ten years of age.Methods and FindingsSMC was introduced into three districts over three years in central Senegal using a stepped-wedge cluster-randomised design. A census of the population was undertaken and a surveillance system was established to record all deaths and to record all cases of malaria seen at health facilities. A pharmacovigilance system was put in place to detect adverse drug reactions. Fifty-four health posts were randomised. Nine started implementation of SMC in 2008, 18 in 2009, and a further 18 in 2010, with 9 remaining as controls. In the first year of implementation, SMC was delivered to children aged 3–59 months; the age range was then extended for the latter two years of the study to include children up to 10 years of age. Cluster sample surveys at the end of each transmission season were done to measure coverage of SMC and the prevalence of parasitaemia and anaemia, to monitor molecular markers of drug resistance, and to measure insecticide-treated net (ITN) use. Entomological monitoring and assessment of costs of delivery in each health post and of community attitudes to SMC were also undertaken. About 780,000 treatments were administered over three years. Coverage exceeded 80% each month. Mortality, the primary endpoint, was similar in SMC and control areas (4.6 and 4.5 per 1000 respectively in children under 5 years and 1.3 and 1.2 per 1000 in children 5-9 years of age; the overall mortality rate ratio [SMC: no SMC] was 0.90, 95% CI 0.68–1.2, p = 0.496). A reduction of 60% (95% CI 54%–64%, p < 0.001) in the incidence of malaria cases confirmed by a rapid diagnostic test (RDT) and a reduction of 69% (95% CI 65%–72%, p < 0.001) in the number of treatments for malaria (confirmed and unconfirmed) was observed in children. In areas where SMC was implemented, incidence of confirmed malaria in adults and in children too old to receive SMC was reduced by 26% (95% CI 18%–33%, p < 0.001) and the total number of treatments for malaria (confirmed and unconfirmed) in these older age groups was reduced by 29% (95% CI 21%–35%, p < 0.001). One hundred and twenty-three children were admitted to hospital with a diagnosis of severe malaria, with 64 in control areas and 59 in SMC areas, showing a reduction in the incidence rate of severe disease of 45% (95% CI 5%–68%, p = 0.031). Estimates of the reduction in the prevalence of parasitaemia at the end of the transmission season in SMC areas were 68% (95% CI 35%–85%) p = 0.002 in 2008, 84% (95% CI 58%–94%, p < 0.001) in 2...

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“…The sample was stratified by health post and caregivers of 636 children in the 3 implementing health posts and of 216 children in the control post were interviewed. In addition, passive surveillance in health facilities was also used to monitor adverse events, which are discussed in greater detail elsewhere 8 .…”

Section: Pilot Studymentioning

confidence: 99%

“…The design of the stepped wedge trial is described in Cisse et al 5 and NDiaye et al . 8 . Briefly, 54 health posts were randomized with respect to the timing of when SMC would be introduced, 9 to start in 2008, 18 to start in 2009, 18 in 2010.…”

Section: Large-scale Implementationmentioning

confidence: 99%

Implementation, coverage and equity of large-scale door-to-door delivery of Seasonal Malaria Chemoprevention (SMC) to children under 10 in Senegal

Bâ

Pitt

Dial

et al. 2018

Sci Rep

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SMC has been introduced widely in the Sahel since its recommendation by WHO in 2012. This study, which provided evidence of feasibility that supported the recommendation, included school-age and pre-school children. School-age children were not included in the 2012 recommendation but bear an increasing proportion of cases. In 2006, consultations with health-staff were held to choose delivery methods. The preferred approach, door-to-door with the first daily-dose supervised by a community-health-worker (CHW), was piloted and subsequently evaluated on a large-scale in under-5’s in 2008 and then in under-10’s 2009–2010. Coverage was higher among school-age children (96%(95%CI 94%,98%) received three treatments in 2010) than among under 5’s (90%(86%,94%)). SMC was more equitable than LLINs (odds-ratio for increase in coverage for a one-level rise in socioeconomic-ranking (a 5-point scale), was 1.1 (0.95,1.2) in 2009, compared with OR 1.3 (1.2,1.5) for sleeping under an LLIN. Effective communication was important in achieving high levels of uptake. Continued training and supervision were needed to ensure CHWs adhered to treatment guidelines. SMC door-to-door can, if carefully supervised, achieve high equitable coverage and high-quality delivery. SMC programmes can be adapted to include school-age children, a neglected group that bears a substantial burden of malaria.

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Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

Cited by 43 publications

References 17 publications

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

Implementation, coverage and equity of large-scale door-to-door delivery of Seasonal Malaria Chemoprevention (SMC) to children under 10 in Senegal

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