Rationale of This Study
To amplify and strengthen previous 2wT findings via adaptation and replication in a new country and new context, the International Training and Education Center for Health, Aurum Institute, Centre for HIV-AIDS Prevention Studies (CHAPS), and technology partner Medic conducted a 2wT RCT in routine VMMC settings in both urban and rural areas in South Africa. In this primary analysis, our objective was to determine whether 2wT improved the ascertainment of AEs and, therefore, the quality of post-VMMC follow-up while reducing HCWs’ workload. We conducted an unblinded, noninferiority RCT comparing two markers of VMMC quality: (1) moderate or severe AE rate ≤day 14 after VMMC and (2) the mean number of in-person postoperative follow-ups in the control and intervention arms. We hypothesized that 2wT would reduce the follow-up visit workload and improve AE ascertainment, reaffirming the evidence that 2wT-based VMMC follow-up is both safe and efficient. If confirmed, this additional evidence for 2wT’s advantages would support efforts to scale 2wT for VMMC follow-up in South Africa and beyond while also supporting the possibility of using 2wT-based telehealth for other acute or postoperative follow-up in routine low- and middle-income country settings.