Funding for this research was provided by:
U.S. President’s Emergency Plan for AIDS Relief (N/A)
Received: 6 May 2020
Accepted: 2 September 2020
First Online: 9 November 2020
Ethics approval and consent to participate
: Ethical approval for each of the source studies was obtained from the relevant ethics committees in the country of data collection and from the trial sponsors. All participants provided informed written consent, or where the enrollee could not read or write, witnessed verbal informed consent. Ethical approvals for XPRES were obtained from the US Centers for Disease Control and Prevention (CDC) Institutional Review Board (IRB) C, the Health Research and Development Division of the Health Research and Development Committee (HRDC) in Botswana, and the University of Pennsylvania IRB No.4. All consent procedures were approved by the ethical review committees. Written informed consent was obtained from all prospective XPRES enrollees. XPRES is registered at ClinicalTrials.gov (trial registration no. NCT02538952). Oversight of study initiation and quarterly review of implementation was conducted by the Office of the Associate Director of Science at CDC Atlanta. TBFT was approved by the research ethics committees of the University of the Witwatersrand, the London School of Hygiene & Tropical Medicine, and the South African Medicines Control Council. All participants provided written or witnessed verbal informed consent. This trial was registered with the ISRCTN registry, ISRCTN35344604, and the South African National Clinical Trials Register, DOH-27-0812-3902.
: Not applicable.
: The authors declare that they have no competing interests.