HIV counselling and testing will be performed every 3 months, per South African national guidelines [50] (Table (Table2).2). Those with a positive confirmatory test will have venous blood drawn to test for HIV drug resistance. Furthermore, those testing positive for HIV will be terminated from the study and provided a referral letter for HIV care and treatment.

We will test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) using a self-collected vaginal swab at baseline and again at months 6, 12, and 24. Self-collected swabs will be shipped monthly to the National Institute for Communicable Diseases (NICD; Johannesburg, South Africa) for nucleic acid amplification testing (NAAT) using the Aptima Combo 2® Assay (Hologic, San Diego, USA) for Neisseria gonorrhoeae and Chlamydia trachomatis and using the Aptima® Trichomonas vaginalis Assay (Hologic, San Diego, USA) for Trichomonas vaginalis. Negative test results will be notified at the next study visit. Positive test results will be notified immediately upon result availability via site-based visits or phone calls. Those with a positive STI test result will be provided a copy of their results and a treatment referral letter per South African STI guidelines [58].

Syphilis testing will be conducted during the enrolment visit only, using the Alere Determine™ Syphilis TP rapid test. Negative tests will be reported by the study nurse to participants; patients testing positive will be referred for further laboratory confirmatory testing and treatment as indicated. All enrolled participants will be tested for Hepatitis B antigen (HBsAg), performed by the National Health Laboratory Service. Participants with a negative test result will be provided hepatitis B vaccination per the South African vaccination schedule [59]; those that test positive will be asked to provide blood for ALT and AST testing to determine liver function and referred for care and treatment. Neither the syphilis nor hepatitis B test results will impact study eligibility.

Urine-based pregnancy testing to detect human chorionic gonadotropin will be conducted every 3 months. If a participant becomes pregnant while enrolled in the study, they will be provided referral letters for prenatal support and care, and counselled on taking PrEP while pregnant, and will be allowed to decide whether they want to continue PrEP. Participants who continue taking PrEP will be monitored by the study clinician and nurses, with pregnancy milestone and birth outcomes recorded and monitored.

Creatinine clearance will be assessed to monitor kidney function at baseline, month 3, month 12, and month 24. Clinical assessment for PrEP continuation will occur if estimated glomerular filtration (eGRF) rate is less than 60 mL/min. If eGRF does not improve, the participant will be terminated from the study due to risk of kidney damage and will be provided a referral letters for renal management and care.

To assess PrEP adherence, tenofovir-diphosphate levels will be assessed at months 3, 6, 12, 18, and 24. Dried blood spots (DBS) will be prepared from venous blood and spotted on Whatman protein saver cards. Drug concentration testing will occur at the University of Cape Town Division of Pharmacology laboratory using DBS TDF testing protocols [60].

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