Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP46099)
Received: 20 January 2021
Accepted: 17 June 2021
First Online: 29 June 2021
: The feasibility study was conducted adjacent to the RCT and implementation of the feasibility study began after an interim analysis of trial data at 6 months, following a recommendation by the trial DSMB for the feasibility study to commence. The clusters (health facilities) were consented prior to implementing the feasibility study. The study was approved by the ethical committees of the Kenya Medical Research Institute’s (KEMRI) National Ethics Review Committee, Kenya; the Liverpool School of Tropical Medicine, UK; the London School of Hygiene and Tropical Medicine, UK; and the Centers for Disease Control and Prevention, Atlanta, Georgia, USA. All participants were consented prior to the interviews; participants in the IDIs provided written informed consent and FGD participants provided verbal informed consent. In Kenya pregnant women aged 15–17 years are considered emancipated minors and were consented directly.
: Not applicable.
: The authors declare they have no competing interests.