Community Based Virus Load Differentiated Care in Rural Africa (CBART)

Study Summary

In 2014 UNAIDS set ambitious goals to achieve 90% virologic suppression rates among individuals on ART. In Zimbabwe <5% of HIV infected individuals received HIV viral load (VL) testing in 2016 and treatment failure rates among children and adolescents range between 35-42% with high rates of drug resistance. Scalable strategies to facilitate improved VL monitoring, genotyping and drug switching for those with persistent viremia are urgently needed.

Our primary objective is to implement “Virus load differentiated care” (VLDC) using mobile health tools to assess near Point of care (POC) vs a Standard of Care (SOC) viral load monitoring to mitigate virologic failure of HIV-infected children and adolescents.

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

All eligible ART patients served by Chidamoyo Christian Hospital (< 25 years of age n > 1,000) will be asked to participate in the study at regular visits when they receive ART. The Ministry of Health is rolling out a new (2017)  standard of care (SOC) including annual virus load (Roche Cobas VL) through the Provincial Laboratory at Chinoyi (100 km from Chidamoyo).

600 HIV infected children and adolescents and young adults (CAY) on ART are randomized (1:1) at enrolment to either SOC (300) or a near POC (300) VLDC monitoring test.

All those who consent to CBART will be offered the SOC VL performed by Roche COBAS at Chidamoyo and the results returned to the hospital within 2-4 weeks of testing. CAY (eligible) subjects enrolled in the CBART protocol will be consented to participate in a clinical diagnostic implementation study providing VL as either SOC centralized Roche Cobas testing performed at Chinoyi or a near point of care (POC) Cepheid GeneXpert assay. Follow-up testing for HIV RNA > 1,000 copies/ml as 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% from the ~ 33% virologic failure rate currently recorded among CAY on first-line therapy. Secondary endpoints include the rate of drug switching and the evaluation and prevention of drug resistance.  The study will enroll up to 600 infants, children 5-10 years, adolescents 10-19 years, and young adults 20-24 years of age, providing data that will guide strategies for management of children and adolescents who are surviving on ART.