PrEP has been approved for use by international and domestic governing bodies in South Africa. Written informed consent will be obtained from participants at multiple time points, including prior to baseline questionnaire, PrEP initiation, and any qualitative interviews. The study protocol has received full ethical approval from the University of Cape Town Human Research Ethics Committee (Ref: 289/2018) and has been registered with ClinicalTrials.gov (NCT03977181). Any and all protocol modifications and annual ethics renewal will be submitted to the University of Cape Town Human Research Ethics Committee for approval.

There are no anticipated problems that are detrimental to the participants; however, expected clinical side effects of DIDIVIR include nausea, dizziness, and diarrhoea; study nurses will be trained on the Southern African HIV Clinicians Guidelines for PrEP used to identify and manage side effects [62]. All research staff will be trained to identify, probe for, and report AEs and social harms (SHs). Occurrence of AEs and SHs will be collected at every visit and recorded in REDCap. All AEs and SHs, with detailed study notes, will be internally reviewed by the study team. An AE list will be compiled and reviewed by the study DSMB and reported to University of Cape Town IRB. A study clinician will review all abnormal test results, liaise with local clinic doctors, and has the authority to terminate participants based on clinical opinion. Upon completion of their 2-year follow-up, all participants will be provided a referral to their local clinics for continuation of PrEP services.

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