Mvalo, Tisungane
Dhaded, Sangappa M.
Manji, Karim P.
Vesel, Linda
Semrau, Katherine E.A.
Kisenge, Rodrick
Somji, Sarah
Chiume, Msandeni
Saidi, Friday
Hoffman, Irving F.
Vernekar, Sunil
Bellad, Roopa
Koppad, Bhavana
Tuller, Danielle E.
Mokhtar, Rana
Lee, Anne C.C.
North, Krysten
Sudfeld, Christopher R.
Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326, OPP1192260 / INV-007326)
Article History
Received: 23 December 2024
Accepted: 7 April 2025
First Online: 23 April 2025
Declarations
:
: This study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA: (1) India Health Ministry’s Screening Committee with Indian Council of Medical Research acting as its secretariat (2019–2674); (2) Directorate of Health and Family Welfare Services, Government of Karnataka which also covers investigators at Women and Children Hospital, Davangere and Chigateri General District Hospital, Davangere (NHM/SPM/04/2019-20); (3) Institutional Ethics Committee of KLE Academy of Higher Education and Research which also covers investigators at JN Medical College, Belagavi and KLES Dr Prabhakar Kore Hospital & Medical Research Center, Belagavi (KAHER/IEC/2019-20/D-2760); (4) Institutional Ethics Review Board of SS Institute of Medical Sciences & Research Centre (IERB/200/2019); (5) Institutional Ethics Committee of JJM Medical College (JJMMC/IEC-01/2019) which also covers investigators at Bapuji Child Health Institute & Research Centre, Davangere, Women & Children Hospital, Davangere and Chigateri General District Hospital, Davangere; (6) Research and Ethics Committee, Directorate of Health Services, Odisha State which also covers investigators at City Hospital Oriya Bazar, Cuttack (155/PMU/187/17); (7) Institutional Ethical Committee, Sriram Chandra Bhanja Medical College, Cuttack (7188); (8) Malawi National Health Sciences Research Committee (NHSRC 2019/Protocol19/03/2250-UNCPM 21905); (9) Tanzania National Institute of Medical Research (NIMR/HQ/R.8a/Vol.IX/3126); (10) Muhimbili University of Health and Allied Sciences (DA.282/298/01.C/); and (11) USA - Harvard T.H Chan School of Public Health (IRB10-0282) which also covers investigators at Boston Children’s Hospital, Brigham and Women’s Hospital, Emory University, PATH and University of North Carolina. Informed consent was obtained from all parents/legally accepted representatives prior to any study procedure or data collection for each study participant.
: Informed consent was obtained directly from patient(s)/ legally accepted representatives.
: The authors declare no competing interests.