Replication Data for: A Cluster Randomized Trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda"

Introduction: Despite significant progress in HIV care globally, a persistent 30-40% of people present with advanced HIV disease with ≤200 CD4 cells/µL. Visitect CD4 Advanced Disease platform is a point-of-care CD4 test being implemented in resource-limited settings. We sought to assess clinical outcomes of survival and retention-in-care among people with advanced HIV disease based on CD4 testing modality. Methods: We performed a cluster randomized clinical trial to evaluate Visitect CD4 compared with onsite standard laboratory-based CD4 testing. The trial was conducted at 16 outpatient HIV clinics in Uganda. Those identified with CD4≤200 cells/µL received a standardized package of care for advanced HIV disease. The primary outcome was 24-week survival with retention-in-care. A costing analysis was performed. Randomization by CD4 methodology was stopped on June 18th, 2024 as the Visitect CD4 Advanced Disease platform was being implemented widely in Uganda and randomization to non-Visitect CD4 platform was unethical if no alternative CD4 strategies were available in a timely manner. We conducted a micro-costing analysis to estimate the resources used for each trial participant over the six-month study period. Results: Between May 5, 2022 and February 18, 2025, 1724 participants were enrolled; 927 participants received Visitect CD4 testing (8 clusters), and 797 received standard CD4 testing (8 clusters). The composite endpoint of death or lost to follow-up occurred in 7.0% (63/901) who received Visitect CD4 testing and 7.2% (57/788) who received standard CD4 testing (Hazard ratio, 0.98; 95%CI, 0.62, 1.34). The estimated risk difference between arms was 0.01% (95%CI, -2.5, 2.5). Median time to antiretroviral therapy initiation was 0 days with Visitect testing versus 7 days with standard CD4 testing (adjusted Hazard ratio, 1.23; 95%CI, 1.07, 1.39). Mean cost of 6-month care was US$115 for Visitect CD4 testing versus US$131 for standard-of-care CD4 testing. Conclusion: Implementation of Visitect CD4 testing demonstrated more rapid initiation of HIV therapy with equivalent 24-week survival and retention-in-care compared with other point-of-care CD4 strategies at equivalent cost. Despite its poor specificity, the Visitect CD4 platform remains a cost-neutral option compared to standard CD4 modalities.