Urine-based HIV-1 self-testing in China: A cross-sectional diagnostic accuracy and usability study.

Expanding HIV testing coverage is essential to achieving the first target of the UNAIDS 95-95-95 goals. Under current circumstances, a novel testing method, urine-based HIV self-testing (HIVST) will be essential to reach undiagnosed people living with HIV. This multicenter cross-sectional study conducted in three sites in China evaluated the diagnostic accuracy, usability, and acceptability of urine-based HIVST in untrained users under real-world conditions. Among 1,495 participants, the urine test demonstrated a sensitivity of 99.44% and a specificity of 100.00%, with perfect agreement between self-testers and professionals. Agreement between home-based and facility-based testing was 100.00%, confirming the reliability of self-testing in unsupervised settings. Most participants were able to perform the test correctly and interpret the results independently, achieving high comprehension and satisfaction levels. Urine-based HIVST is accurate, convenient, and highly acceptable, serving as a promising alternative to blood- or oral fluid-based approaches to better accommodate diverse needs and preferences. This non-invasive and user-friendly testing option is expected to expand testing coverage and contribute to achieving the first UNAIDS 95 target in China.