Beardmore-Gray, Alice http://orcid.org/0000-0001-9923-4912
Vousden, Nicola
Charantimath, Umesh
Katageri, Geetanjali
Bellad, Mrutyunjaya
Kapembwa, Kunda
Chinkoyo, Sebastian
Vwalika, Bellington
Clark, Matthew
Hunter, Rachael
Seed, Paul
Goudar, Shivaprasad
Chappell, Lucy C.
Shennan, Andrew
Funding for this research was provided by:
Medical Research Council (MR/R021376/1)
Article History
Received: 29 July 2020
Accepted: 11 November 2020
First Online: 23 November 2020
Ethics approval and consent to participate
: The trial will be conducted according to the principles of the Declaration of Helsinki (October 2008) and all applicable regulatory requirements. The conduct of this study will be in full compliance with Good Clinical Practice. Copies of the protocol, participant information leaflet and informed consent form have been approved by national or institutional research ethics committees in both India and Zambia, and in the UK:King’s College London: HR-19/20-13535University of Zambia: UNZA-301/2019Bagalkot (India): SNMCIEC/1.1/2019-2020Belagavi (India): KAHER/IEC/2019-20/D-251119016The chief investigator or their delegate will submit and, where necessary, obtain approval from the relevant research ethics committee (REC) for any substantial amendments. All protocol modifications will be communicated promptly to sites once approved by the sponsor and the REC. Written informed consent will be obtained by the principal investigator or another member of the study team with delegated authority.
: Not applicable.
: The authors declare that they have no competing interests.