Adejuyigbe, E. A.
Agyeman, I.
Anand, P.
Anyabolu, H. C.
Arya, S.
Assenga, E. N.
Badhal, S.
Brobby, N. W.
Chellani, H. K.
Chopra, N.
Debata, P. K.
Dube, Q.
Dua, T.
Gadama, L.
Gera, R.
Hammond, C. K.
Jain, S.
Kantumbiza, F.
Kawaza, K.
Kija, E. N.
Lal, P.
Mallewa, M.
Manu, M. K.
Mehta, A.
Mhango, T.
Naburi, H. E.
Newton, S.
Nyanor, I.
Nyako, P. A.
Oke, O. J.
Patel, A.
Phlange-Rhule, G.
Sehgal, R.
Singhal, R.
Wadhwa, N. http://orcid.org/0000-0002-9435-1842
Yiadom, A. B.
Funding for this research was provided by:
Bill and Melinda Gates Foundation (202408063-1)
Article History
Received: 28 July 2022
Accepted: 20 February 2023
First Online: 10 April 2023
Declarations
:
: Since this is a multi-country, multicenter study with a single protocol, approvals on the same protocol have been obtained from the WHO Ethics Review Committee (reference no. EC0002910 approved on 23 Nov 2017) as well as the local Institutional Review Boards (IRBs) of the five participating hospital sites: Ghana’s School of Medical Sciences/Komfo Anokye Teaching Hospital Committee on Human Research, Publication and Ethics (reference number CHRPE/AP/170/19, initial approval on 11 April 2019), Tanzania’s National Institute for Medical Research (reference number NIMR/HQ/R.8c/Vol. I/708, initial approval on 17 June 2019), Malawi’s College of Medicine Research and Ethics Committee (COMREC) (reference number P.08/17/2235, initial approval on 21 April 2020), Nigeria’s OAUTHC Ethics and Research Committee (reference number IRB/IEC/0004553, approval on 30 May 2019), and New Delhi-India’s Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee (reference number IEC/VMMC/SJH/Project/2019–06/52, initial approval on 21 October 2019). Each updated version of the protocol was approved by each of the above-mentioned ethics committees.A verbal consent was taken from the parents during the 29-day follow-up visit in the main iKMC trial, and a written informed consent for participation in the follow-up study is obtained at the time of initiation of the 3-year follow-up.
: Not relevant.
: The authors declare that they have no competing interests.