Study Design
WEST
We conducted a 2-arm, prospective, unblinded, noninferiority RCT in 3 urban VMMC facilities in the Ekurhuleni district (Gauteng province) and 4 rural VMMC outreach sites in the Bojanala district (North West province) in South Africa. We purposively selected high–VMMC volume sites in urban and rural locations within 1 day of travel from the Aurum headquarters to ease supervision, represent different service delivery models, and consider limited study resources. The unit of randomization was individuals receiving VMMC. The participants were randomized in a 1:1 ratio and divided equally into urban and rural participants. Across all settings, we compared 2 groups of adult participants with cell phones: (1) participants who received routine care via in-person follow-up visits on days 2 and 7 (control) and (2) participants who received and responded to a daily SMS text message (2wT). The 2wT group had in-person follow-up only if desired or if an AE was suspected.