Funding for this research was provided by:
Helse Vest (912267)
Received: 1 September 2020
Accepted: 7 April 2021
First Online: 29 April 2021
: This study will be conducted in accordance with the latest South Africa revision of the Declaration of Helsinki, good clinical practice, and local and international regulatory requirements. Ethical approval of the ProRIDE Trial has been obtained from the Regional Committee for Medical and Health Research Ethics Western Norway in September 2019 (REK Vest 2019/1025) (see “Additional file InternalRef removed”) and from the National Institute of Medical Research in Tanzania (NIMR) in April 2020 (see “Additional file InternalRef removed”). The formal application to conduct the RCT in Tanzania has in June 2020 been submitted to the regulatory authority; Tanzania Medicines and Medical Devices Authority (TMDA). A response to queries raised by TMDA was submitted in December 2020. Approval has been obtained from TMDA, but technical issues have caused delays in the release of the certificate. Parent/caretaker will receive oral and written information about the trial and must give a written informed consent before their involvement in the trial. All information is translated in Kiswahili and trained investigators participating in the recruitment process speak the local languages. Participants are free to withdraw from the trial at any time.
: No individual or sensitive data relating to an individual person will be published. Thus, we do not need an informed consent from a person or a parent/legal guardian for the final publication.
: The authors declare that they have no competing interests.