Outcomes
’ retention
We prespecified measuring outcomes of successful PrEP continuation (ie, HIV testing, PrEP refilling, and PrEP adherence) 12 months following randomization. For HIV testing, we measured (1) recent HIV testing, defined as any self-reported testing in past 6 months, and (2) continuous HIV testing, defined as testing 3 or more times since randomization (once between randomization and the 6-month clinic visit [self-reported], once at the 6-month visit [clinic records], and once between the 6- and 12-month visits [self-reported]). For PrEP refilling, we measured (1) refilling at the 12-month visit and (2) refilling at both the 6- and 12-month visits (both measured using pharmacy dispensing records). For PrEP adherence, we measured (1) adherence at the 12-month visit and (2) adherence at both 6- and 12-month visits. We categorized any detectable tenofovir-diphosphate (TFV-DP) concentration in DBS, measured using liquid chromatography tandem mass spectrometry,All study outcomes were binary and dependent on participants’ retention in care at the 6- and 12-month clinic visits. We used inclusive retention windows for each visit that went until 2 weeks before the start of participants’ next scheduled visit, resulting in different retention windows for participants in the intervention and SOC groups at 6 months. For the 12-month visit, participants were eligible for follow-up for up to 15 months.