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  5. Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
 
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Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
File(s)
Master statistical analysis plan attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia.pdf (1.21 MB)
Published version
Author(s)
Yukich, Joshua
Eisele, Thomas P
terKuile, Feiko
Ashton, Ruth
Staedke, Sarah
more
Type
Journal Article
Abstract
This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites.
Date Issued
2023-11-29
Date Acceptance
2023-10-23
Citation
Trials, 2023, 24
URI
http://hdl.handle.net/10044/1/114361
URL
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07762-7
DOI
https://www.dx.doi.org/10.1186/s13063-023-07762-7
ISSN
1745-6215
Publisher
BMC
Journal / Book Title
Trials
Volume
24
Copyright Statement
© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
License URL
https://creativecommons.org/licenses/by/4.0/
Identifier
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07762-7
Subjects
Cluster randomized control trial
Life Sciences & Biomedicine
Malaria
Medicine, Research & Experimental
Research & Experimental Medicine
Science & Technology
Statistical analysis plan
Vector control
Publication Status
Published
Article Number
771
Date Publish Online
2023-11-29
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