Study design and participants
SECONDARY
This open-label, non-inferiority, randomised, controlled, phase 2/3 trial was done in four secondary schools (Kilindi, Kwale, Ndagoni [Chake Chake District], and Kiuyu [Wete District]) on Pemba Island, Tanzania. Adolescents aged 12–19 years who tested positive for The trial was conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval was obtained from the Zanzibar Health Research Institute (NO.ZAHREC/03/PR/OCT/2020/23) and Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2020–00042). Participants aged 18 years or older provided written informed consent, whereas those younger than 18 years were asked to provide written assent and a guardian or parent provided written informed consent. The trial protocol including the study design and methods were published elsewhere.