Document is current

Article History

Received: 12 April 2023

Accepted: 7 July 2023

First Online: 15 August 2023

Declarations

:

: We assert that all procedures contributing to this study comply with the ethical guidelines and standards of the relevant national and institutional committees on human experimentation and with the Declaration of Helsinki. Ethical approval has been obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC/00003735/2021) and UCL Research Ethics Committee (5672/006). All staff (including peer navigators) will be provided with training on research ethics including confidentiality, voluntary participation and good clinical practice. We will ensure confidentiality at all levels of the research process, and none of our reports, presentations or articles will contain study participants identifying information. Pseudo names will be used when reporting the data particularly qualitative data. Each participant will be assigned a unique non-identifying participant identification number. Prior to their involvement in the study, participants will be provided with adequate information about the study and they will be allowed to ask questions for clarifications. Voluntary informed consent will be ensured once participants have the full understanding of the study procedures. Written informed consent will be obtained from all participants aged 18–30 years; written assent from participants aged 15–17 years, with written informed consent from their parents or guardian. All participants will have the right to withdraw from the study at any time. it will be stated clearly to participants that their refusal to participate in the study or desire to withdraw from the study will not affect them or any other health related services they are currently accessing, including peer navigator support and clinical services provided in the study mobile clinics and DoH clinics. We have established a Trial Advisory Group with clinical trials, PrEP, statistical and social science expertise to oversee the trial. This is an effectiveness trial of different models of service delivery and all tests and drugs used are approved for clinical use in South Africa. All clinical care follows South African clinical guidelines. The risk of harm is anticipated to be low and detailed in the study protocol. For the costing, additional ethical approval has been obtained from the University of Witwatersrand Human Research Ethics Committee (Medical) (HREC 220708) and Boston University IRB (H43001). All deviations from protocol, protocol modifications will be communicated to Trial Steering Committee, Biomedical Research Ethics Committees (UCL and KZN), trial registry and in the trial publications.

: Not applicable.

: The authors declare no competing interests.