Funding for this research was provided by:
UK-Medical Research Council/Department for International Development/Wellcome Trust/Department of Health and Social Care (MR/N006046/1)
Text and Data Mining valid from 2019-10-21
Received: 19 February 2019
Accepted: 4 September 2019
First Online: 21 October 2019
Ethics approval and consent to participate
: This protocol, the informed parent consent and participant assent documents, and participant information sheets have been reviewed and approved by the Research Ethics Committees at the Kenya Medical Research Institute, Nairobi, Kenya (KEMRI protocol #3215) and the Liverpool School of Tropical Medicine, Liverpool (LSTM protocol #15–005). These ethics approvals cover all 96 participating Siaya schools. The Centers for Disease Control and Prevention gave approval for reliance on the KEMRI IRB (2016–136). Registry approval for trailing menstrual cups was given by the Kenyan Poisons and Pharmacy Board (ECT_16_07_06). Annual renewal of approvals by KEMRI, LSTM, and KPPB are required based on reporting of trial activities in the prior year. Written parent consents and written participant assents were collected. In the case that a parent was illiterate and could not read, verbal consent with a witnessing literate adult of the parents choosing was collected.
: Not applicable.
: The authors declare no conflict of interests.