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Correspondence: Sylvia M. LaCourse, sylvial2@uw.edu
Author contributions: GJ-S, BAR, JK and SML designed the randomised clinical trial. SML, GJ-S, BAR, TRH, LMC, JK, DM, AJW and EM-O developed the study protocol. GJ-S is the principal investigator and protocol chair and TRH is the immunology principal investigator. JK is the protocol co-chair and country principal investigator. EM-O is the Pediatric Clinical TB lead.
GJ-S, BAR and SML are responsible for the statistical design of the trial and data analysis of the primary outcomes. SML is the project director and drafted the statistical analysis plan overseen by BAR, the study biostatistician. SML, DM, AJW, JK and JNE participated in trial implementation and manuscript preparation.
TRH designed the immunological studies and oversees the immunological work related to the trial. SML wrote the first draft of the manuscript. All authors critically revised, read and approved the final manuscript.
We would like to acknowledge the iTIPS study staff (Jepharson Mecha, Celestine Adogo, Jovine Akinyi Mbata, Kevin Sellanga Ochieng, Mercy Olilo, Aggrey Olimba, Cynthia Achieng Ongete, Esther Achieng, Dancun Otieno Aroko, Elizabeth Wanjiku Mwangi), the Kisumu and Siaya County Directors of Health, health facility staff, UW-Kenya and Kenyatta National Hospital Research and Programs operational staff (including Emma Nzove).
Qiagen provided discounted QFT-Plus test kits, and the Kenya Medical Research Institute (KEMRI) CDC in Kisumu, Kenya performs the QFT-Plus assays. We thank the University of Washington Global Center for the Integrated Health of Women, Adolescents, and Children (Global WACh) for comments and insights provided during study design and manuscript development.
Most of all, we thank the families who have and will participate in the study. This study is funded by the Thrasher Research Fund.
Disclosures: None.
This work was supported by the Thrasher Research Fund, National Institute of Allergy and Infectious Diseases (NIAID), Fulbright programme awarded to the Northern Pacific Global Health Fellows Program by the Fogarty International Center of the National Institutes of Health (NIH/Fogarty), and National Center for Advancing Translational Sciences at National Institutes of Health (NIH) (Thrasher to GJ-S, NIH/NIAID K23AI120793 to SML, NIH/NIAID 2K24AI137310 to TRH, NIH/Fogarty R25TW009345 to AJW and NIH UL1TR000423 for REDCap).
© 2020 Author(s).