Abstract
BACKGROUND: Many people with HIV experience considerable barriers to accessing HIV clinic services. Options that would permit blood sampling that preclude the need for in-clinic visits and increase privacy would aid in overcoming many of the obstacles that hinder receiving adequate HIV care. METHODS: In Project Home-MaDE, 57 participants were evaluated for their ability to collect fingerstick blood (minimum 250 µL) in Microtainer tubes (MCT), then package and overnight mail specimens following kit instructions without assistance. Specimens were required to arrive at the laboratory within four days of collection. Plasma viral loads obtained from mailed blood were compared to matched venipuncture samples collected on the same day. For fingerstick-derived plasma, the limit of quantitation was 210 copies/mL, a benchmark relevant for Undetectable = Untransmissible prevention. A non-reactive or below-quantifiable result reflected viral suppression. Self-collected dried blood spots which have historically been used for remote blood sampling were likewise evaluated. RESULTS: Forty-seven (82%) participants had acceptable MCT samples for testing. Ten specimens were rejected either for excessive time and temperature (n = 1) or insufficient sample volume (n = 9). Of the 34 participants who initially experienced difficulty in obtaining sufficient sample 29 elected to retry and 24 were successful. All 46 acceptable MCT plasmas tested provided accurate results as compared to the suppression levels in their matched conventional venipuncture viral loads. CONCLUSION: Under a rigorous protocol, plasma from mailed, self-collected fingersticks by untrained individuals were suitable for remote viral suppression monitoring. This evaluation, however, was limited to temperatures and courier service in the U.S. Approved testing options for self-collected samples may support HIV telemedicine and empower persons to overcome barriers to care services.