The co-principal investigators/corresponding authors take responsibility for the scientific validity of the study protocol, assessment of study quality and conduct, as well as for the scientific quality of the final study report. The primary author oversees the coordinating centre and takes responsibility for the day-to-day study implementation in collaboration with three other co-authors (Foundation for Professional Development). A DSMB will be made up of four invited national and international experts, at least two of whom are clinically trained and knowledgeable about PrEP and at least one biostatistician. DSMB members will have no direct association with this study and will be independent from any professional or financial conflict of interest with the research project and/or study investigators. The DSMB will review in aggregate on a bi-annual basis, any adverse events (AEs) that occur. Though no serious adverse events (SAEs) are reasonably expected during this trial, should they occur the DSMB will review them in real time. Trial conduct will be continuously audited as part of quarterly meetings of the study team, and annually by the University of Cape Town Human Research Ethics Committee as part of mandatory renewal of ethics approval.

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