Adverse event reporting and harms
ADVERSE EVENTS, ADVERSE EVENT
This is an implementation study and all tests and drugs used are approved for clinical use in South Africa. All clinical care follows South African clinical guideline. The risk of harm is anticipated to be low. Adverse events (AEs) and serious adverse events (SAE) will be captured through the process evaluation, community engagement units and community advisory boards, the hotline, as well as the peer navigators and clinic staff and logged using our incident reporting form for up to up to 12 months after the start of the intervention. Reported AEs and SAEs will be monitored, categorized based on an established grading system, and followed-up accordingly by AHRI. All AEs and SAEs will be reported to the principal investigator, Trial Steering Committee, UKZN and UCL Biomedical Research Ethics Committee.