Between October 2016 and October 2018, HIV–negative women were recruited from Cape Town and Johannesburg, South Africa, and Harare, Zimbabwe (ClinicalTrials.gov NCT02732730). Women were eligible if they were literate, female at birth, ages 16 to 25 years, had vaginal or anal sex in the month prior to screening, and reported interest in taking PrEP in the 36-item HIV Prevention Readiness Measure about risk behaviors, medical care utilization, and PrEP beliefs (adapted from the HIV Treatment Readiness Measure) [15 (link)]. To screen out lower risk women, we required a VOICE rick score ≥5, which was associated with >6% HIV incidence in prior cohorts [16 (link)]. In addition, women needed to have regular access to a mobile phone with SMS capacity, be hepatitis B seronegative, and willing to accept hepatitis B virus (HBV) vaccine (if previous immunity was not confirmed), have normal renal function (creatinine clearance >60 ml/min), and not be pregnant. Study visits were at months 1, 2, 3, 6, 9, and 12 with HIV and pregnancy testing at every visit (S1 Text).
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