Community Based Virus Load Differentiated Care in Rural Africa

This is an open label randomized trial among HIV infected children and adolescents and young adults receiving ART at 8 treatment outreach sites near their homes provided by Chidamoyo Mission Hospital. The investigators will implement virus load (VL) testing at "near point of care" using either the GeneXpert Quant or the SAMBA to evaluate the safety, clinical and virologic outcomes of near POC monitoring of virus load at the Chidamoyo Christian Hospital in Mashonaland West Zimbabwe.

The investigators hypothesize that our proposed package of care will result in a decrease in virologic failure, increase virologic suppression and prevent drug resistance in this key population in a rural ART treatment program. Process and cost data will be collected for subsequent cost-analysis.

HIV infected children and adolescents on ART will be randomized (1:1) to either SOC (300) or a near POC VLDC monitoring. SOC VL is performed by Roche COBAS at the Provincial Hospital Chinhoyi and the results returned to the hospital within 4 weeks. Those randomized to near POC will be tested with the Cepheid GeneXpert assay and results are available within 3 days. Follow-up repeat testing for HIV RNA > 1,000 copies/ml is offered using the same virologic monitoring system at the next drug/clinic visit within 3 months.

The hypothesis is that viral load monitoring and potentially genotyping to sustain suppression to < 1,000 copies/ml will reduce treatment failure to < 15%. Secondary endpoints include the rate of drug switching and the evaluation and prevention of drug resistance. The study will enroll up to 600 children (3 -10) years and adolescents (11-21) years, providing data that will guide strategies for management of children and adolescents who are surviving on ART.

Primary Objective: To determine if implementation of point of care virus load differentiated care (POC virus load), targeted genotyping and mHealth tools will result in improved virologic suppression among children and adolescents (<21years) on ART.