Kenya has a large burden of pediatric HIV and viral suppression (VS) remains lower among children living with HIV (CLHIV) than adults; feasible, scalable, and cost-effective approaches to ensure VS among CLHIV are urgently needed. The goal of the Opt4Kids study was to determine the impact of point-of-care (POC) viral load (VL) and targeted drug resistance mutation (DRM) testing in improving VS among children on antiretroviral therapy (ART).
We conducted a randomized controlled trial to evaluate the use of POC VL and targeted DRM testing among children aged 1-14 years on ART at five health facilities in western Kenya. Children were randomized 1:1 to intervention (POC VL every 3 months, targeted DRM testing for VL ?1000 copies/ml, and clinical management support) vs. control (standard-of-care: VL testing every 6 months, DRM restricted to second line ART failure via centralized approvals) groups and followed for 12 months. Our primary outcome was VS (VL <1000 copies/mL) 12 months after enrollment by study group.
Of the 704 participants enrolled, the median age at enrollment was 9 years (interquartile range [IQR] 7, 12), 344 (49%) were female, and the median time on ART was 5.8 years (IQR 3.1, 8.6). At 12 months, 90% (283/313) in the intervention group and 92% (287/313) in the control group were virally suppressed (risk ratio (RR) 0.99, 95% confidence interval [CI] 0.94, 1.03). We identified 122 episodes of viremia in intervention participants, of which 107 (88%) samples successfully underwent DRM testing. In contrast, 144 episodes of viremia were identified but only two DRM tests were conducted in the control group. After any non-VS, children were not more likely to achieve VS at 12-months in the intervention vs. control group (RR 1.08, 95% CI 0.92, 1.27). The median turnaround time in days for VL results was 1 (IQR 0, 1) and 14 (IQR 9, 21) in the intervention and control groups, respectively.
Overall, VS was high in both groups and was not significantly improved among CLHIV undergoing our intervention of POC VL and targeted DRM testing compared to standard of care. However, VL turnaround time was faster in the intervention group, which could be useful programmatically. Further research is needed to evaluate combination interventions, that best utilize POC VL testing coupled with psychosocial support, to optimize VS for CLHIV.