Funding for this research was provided by:
UK/South African MRC Newton Fund Grant
UK/South Africa MRC Newton Fund
Received: 29 January 2019
Accepted: 24 September 2019
First Online: 12 October 2019
Ethics approval and consent to participate
: The Institutional Review Boards of the University of the Witwatersrand, South Africa, the University of Liverpool, UK, and the London School of Hygiene and Tropical Medicine, UK have approved the study. Ongoing review and approval of the study will be maintained by these committees. Requests for protocol amendments will be made in writing to Institutional Review Boards. An independent data and safety monitoring board (DSMB) comprised of an Academic Clinical Chair, a TB Expert and a Statistician has been formed, and will meet prior to trial commencement, when they will review the design, planned conduct and proposed analyses, and at least annually thereafter. Interim blinded analyses will be provided to the DSMB, with data unblinded at their request. The DSMB will make recommendations to investigators to continue, or prematurely halt the study. Written informed consent will be recorded from index TB cases (or their primary caregiver, if deceased or younger than 14 years of age), and from household members, either at baseline home visit (Intervention group), or at 15 month outcome assessment visit (Control group) by Good Clinical Practice-trained Study Research Assistants and Nurses. The trial will be reviewed by a site monitoring team from the University of the Witwatersrand, Johannesburg.
: Not applicable.
: The authors declare that they have no competing interests.