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

Title
RAPID-VL intervention improves viral load ordering, results turnaround time and viral suppression: a cluster randomized trial in HIV clinics in Uganda
Presenter
Vivek Jain
Authors
V. Jain * (1), A. Owaraganise (2), D. Black (1), B. Twinamatsiko (2), M. Ayebare (2), B. Wandera (2), F. Semitala (2), C. Twinamatsiko (2), S. Kabageni (2), M. Naluguza (3), L. Mills (3), A. Namale (3), A. Zee (4), C. Dawson Rose (5), E. Charlebois (6,7), M. Kamya (8,2)
Institutions
(1) University of California, San Francisco, Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, San Francisco, United States, (2) Infectious Diseases Research Collaboration (IDRC), Kampala, Uganda, (3) Centers for Disease Control and Prevention, Kampala, Uganda, (4) Centers for Disease Control and Prevention, Atlanta, United States, (5) University of California, San Francisco, Dept. of Nursing, San Francisco, United States, (6) University of California, San Francisco, Division of HIV, Infectious Diseases & Global Medicine, San Francisco, United States, (7) University of California, San Francisco, Center for AIDS Prevention Studies, San Francisco, United States, (8) Makerere University, Department of Medicine, Kampala, 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.