A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in...

Despite significant progress in HIV care globally, a persistent 30-40% of people present with advanced HIV disease with ≤200 CD4 cells/µl. The 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.

We performed a cluster randomized clinical trial to evaluate the 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 18 June, 2024, as the Visitect CD4 Advanced Disease platform was being implemented widely in Uganda, and randomization to non-Visitect CD4 platforms 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 6-month study period.

Between 5 May 2022 and 18 February 2025, 1724 participants were enrolled; 927 participants received Visitect CD4 testing (eight clusters), and 797 received standard CD4 testing (eight 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, 0.69, 1.40). 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, 1.05, 1.45). Mean cost of 6-month care was US$115 for Visitect CD4 testing versus US$131 for standard-of-care CD4 testing.

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.

In this cluster randomized trial, we identified that participants with advanced HIV disease who were randomized to receive the Visitect CD4 Advanced Disease platform had equivalent 24-week survival with retention-in-care compared with standard CD4 testing strategies.