Study design
This was a prospective randomized open label trial of two strategies for VL differentiated care monitoring of virologic outcome among CALWH receiving ART at 8 treatment ROS near their homes provided by CCH. Between February 2018 and July 2019, 451 CALWH (ages 3–24) who had been on ART for more than 1 year at CCH or at ROS were enrolled and randomized. This was a parallel group randomized trial where only participants were blinded and assigned (1:1) to either SAMBA or SOC VL testing. The random allocation was not concealed and allocation sequences were generated by the data team, who also assigned the participants to the interventions. All study procedures and enrolment were integrated into routine care from existing clinic and outreach site staff (clinicians/nurses) as part of routine service delivery. Nurses and clinicians recruited the participants and were not blinded to the randomization. There were no anticipated risks associated with clinic-based VL differentiated care since all study procedures were consistent with the National SOC VL. Participants were seen bimonthly either through the CBART program at ROS or at youth clinics at the CCH. We abstracted data from medical records to a structured data retrieval form. Information collected included age, gender, weight, clinical and laboratory data (VL and CD4 count), ART regimen, ART initiation and cotrimoxazole prophylaxis dates, primary caregiver and site of HIV care (CCH versus ROS). Treatment dispensed, drug switching and VL measures were captured into a MS Access database.