RAPID-VL intervention improves viral load ordering, results turnaround time and viral suppression: a cluster randomized trial in HIV clinics in Uganda


BACKGROUND: HIV viral load (VL) monitoring is crucial for long-term antiretroviral therapy (ART) success. However, challenges in Africa include suboptimal VL ordering by clinicians, delayed VL turnaround time, and suboptimal VL counseling/interpretation.
METHODS: A cluster-randomized controlled 'pre-post' trial was conducted in 20 PEPFAR-supported HIV clinics (10 intervention/10 control) in southwestern Uganda. We enrolled four high-risk patient groups (pregnant/breastfeeding women, children/adolescents (2-17years), viremic patients, patients overdue for VL), and non-high-risk adults. Retrospective clinic data (2017-2018 'pre-intervention') on N=1200 participants (60/clinic; 20 clinics) was obtained, and N=1200 new participants enrolled prospectively (2018-2020 'post-intervention'; N=2400 total). The RAPID-VL intervention included (1)-a VL-ordering flowsheet with quarterly performance feedback, (2)-rapid near-point-of-care VL testing (Cepheid GeneXpert) with same/next-day telephone delivery of VL results to patients, and (3)-clinician training on VL results counseling. Control clinics used standard-of-care VL ordering/testing/counseling per Uganda's national program. Primary outcomes were (1)-VL turnaround time (result delivery to patients) and (2)-% of visits with guideline-concordant VL ordering. Secondary outcome was VL suppression one-year post-intervention. Intervention effect was analyzed by cluster-adjusted difference-in-difference estimation.
RESULTS: Of 2400 participants, 66.4% were female, mean age 37 (range 18-88), and median ART duration 2.8 years. Pediatric participants were 50.9% female, mean age 9 (range 2-17), and median ART duration 3 years. Pre-intervention VL turnaround time was not significantly different between intervention and control clinics (mean 73.4 days;p=0.20 cluster-adjusted).
Post-intervention, turnaround time was significantly reduced in intervention vs. control clinics (median=1 vs. 56 days). Intervention-associated change in mean turnaround time, adjusting for temporal trends and clinic-level clustering, was -67.3 days (p<0.0001). Significant reductions were seen within every patient subgroup. Pre-intervention, VL ordering was not significantly different in intervention vs. control clinics (70.5% vs. 72.2%;p=0.081). Post-intervention, the intervention-associated improvement in VL ordering was +10.4% (p=0.01). One-year viral suppression post-intervention in measured participants was 83.1% in intervention clinics and 76.0% in control clinics (+7.1%, p=0.0091).
CONCLUSIONS: In this large cluster RCT in Uganda, a multi-component intervention with boosted clinician training and rapid near-point-of-care VL testing: (1)-significantly reduced VL turnaround time, (2)-significantly improved guideline-concordant VL ordering, and (3)-significantly improved 1-year viral suppression. The RAPID-VL intervention may strengthen VL operations within national ART programs.