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Article History

Received: 18 August 2019

Accepted: 24 December 2019

First Online: 11 February 2020

Ethics approval and consent to participate

: Ethical approvals for this study 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. For the SOC cohort, a waiver of informed consent for chart abstraction was granted in accordance with 45CFR 46.116 (d). Written informed consent was obtained from all EC and EC+X 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. Per guidance from oversight bodies, XPRES was registered at ClinicalTrials.gov following the change in the US Health and Human Services (HHS) and National Institutes of Health (NIH) accepted definition of a clinical trial on January 25, 2015 []. At the time of study initiation on August 1, 2012, investigators and oversight bodies did not consider XPRES met the pre-2015 HHS and NIH definition of a clinical trial that was testing the “safety and effectiveness” of an intervention, because the XPRES interventions were already considered safe and were recommended by the Ministry of Health and World Health Organization.

: Not applicable.

: The authors declare that they have no competing interests.