Nash, S.
,
Dietrich, J.
Ssemata, A. S.
Herrera, C.
O’Hagan, K.
Else, L.
Chiodi, F.
Kelly, C.
Shattock, R.
Chirenje, M.
Lebina, L.
Khoo, S.
Bekker, L-G
Weiss, H. A.
Gray, C.
Stranix-Chibanda, L.
Kaleebu, P.
Seeley, J.
Martinson, N.
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (RIA2016MC-1616 CHAPS RIA2016MC)
Article History
Received: 20 May 2020
Accepted: 22 September 2020
First Online: 30 October 2020
Ethics approval and consent to participate
: Ethical approval was granted from the University of Cape Town (290/2018), the University of the Witwatersrand (180906B, M1811148 and 180108), the Uganda National Council for Science and Technology (HS2534), the Uganda National Drug Authority (CTA0112) and the Medical Research Council of Zimbabwe (MRCZ/A/2356), and central ethical approval has been confirmed from the London School of Hygiene and Tropical Medicine (15629 and 16182). Signed informed consent was required from all participants prior to enrolment. For social science participants under 18, a waiver of consent has been granted by ethics boards in Cape Town (290/2018, letter dated 18 July 2018) and Zimbabwe (as part of the initial submission, MRCZ/A/2356). For Entebbe, the Uganda National Council for Science and Technology 2014 guidelines (“National guidelines for research involving humans as research participants”) permit those aged 14–17 to consent to participate without the need for parental approval.The study sponsor is the Perinatal HIV Research Unit, Johannesburg, South Africa, and the principal investigator is Neil A Martinson. Key protocol modifications will be communicated from the sponsor to relevant parties in a timely manner.
: Not applicable.
: The authors declare that they have no competing interests.