2.1. Study Procedures
VF, provider-determined
NAIROBI
Whole blood was collected from study participants for POC VL testing and separated into plasma for testing using a GeneXpert system (Cepheid, Nairobi, Kenya) on site at study facilities or via daily transport to a facility less than 2 km away [Children in the intervention group underwent DRT at episodes of VF detection. A multidisciplinary committee, called the Clinical Management Committee (CMC), which included facility providers and peer leaders, HIV implementing partner technical advisors, the chairperson of the local HIV Technical Working Group, and study principal investigators, reviewed the DRT results to provide interpretation and clinical management recommendations. The CMC utilized a standardized Kenya Ministry of Health (MoH) case summary form, prepared by facility providers and research staff in advance of the CMC review, to discuss the cases. The CMC met as the DRT results were available, often weekly, throughout the study period. The CMC recommendations were summarized orally during virtual meetings and shared in writing along with the DRT results to facility providers within one week.For children in the control group, providers were instructed to follow current Kenya MoH guidelines for the management of any child with VF, which recommended enhanced adherence counseling for children with VF and repeat viral load (VL) testing after three months of provider-determined “good” adherence. DRT was limited to patients approved by the regional HIV Technical Working Group and generally included those failing a PI-containing regimen or with persistent VF despite good adherence. The Technical Working Group reviewed case summaries and DRT results, when available, and provided guidance to facility staff on patient management, though facility staff did not participate in working group meetings. In practice, only two control group participants had DRT results which were received after the study end. Therefore, DRT results from control group participants prior to the final study visit were excluded from this analysis. At the study end, participants in the control group underwent intervention procedures, including CMC review for those with DRT results.