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BackgroundHuman immunodeficiency virus (HIV) viral load (VL) monitoring is critical for antiretroviral therapy (ART) management. Point-of-care (POC) VL testing has been reported to be feasible and preferred over standard-of-care (SOC) testing in many low- and middle-income country settings where rapid results could improve patient outcomes.MethodsThe timeliness of receipt of VL results was evaluated in an open-label, randomized, controlled trial among patients newly initiating ART. Clinical outcomes with POC VL monitoring using Cepheid Xpert vs SOC VL at Jos University Teaching Hospital and Comprehensive Health Centre Zamko in Nigeria were assessed. We determined time between specimen collection and recording of VL in patient charts, receipt of results, and ART switch for those who met virologic failure criteria.ResultsBetween April 2018 and October 2019, we screened 696 ART-naive individuals; 273 were randomized to POC and 268 to SOC HIV-1 VL testing. Participants in the POC arm received VL results significantly faster than those in the SOC arm (0.1 median days, interquartile range [IQR], 0.1–0.2 vs 143.1 days, IQR, 56.0–177.1, respectively; P < .0001). Participants in the POC arm with confirmed virologic failure vs those in the SOC arm were switched more rapidly to a second-line regimen (0 median days, IQR, 0–28 vs 66 days, IQR, 63–123, respectively; P = .03).ConclusionsPOC VL testing resulted in significant improvement in the timeliness of VL result receipt by patients and use for effective HIV clinical management. In patients experiencing VL failure, POC monitoring enabled prompt switching to second-line ART regimens.Clinical Trials RegistrationNCT03533868.

Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. Clinical Trials Registration NCT03533868.

HIV viral load (VL) monitoring is critical for antiretroviral therapy (ART) management. Point-of-care (POC) VL testing has been reported to be feasible and preferred over standard of care (SOC) testing in many low- and middle-income country (LMIC) settings, where rapid results could improve patient outcomes.The timeliness of receipt of VL results was evaluated as part of an open label randomized controlled trial among patients newly initiating ART assessing clinical outcomes with POC VL monitoring using Cepheid Xpert® versus SOC VL at Jos University Teaching Hospital (JUTH) and Comprehensive Health Centre Zamko (CHCZ), in Nigeria. We determined the median number of days between specimen collection and recording of VL results in patient charts, patient receipt of results, and ART switch for those meeting virologic failure criteria.Between April 2018 and October 2019, we screened 696 ART-naïve individuals; 273 were randomized to POC and 268 to SOC HIV-1 VL testing. Participants in the POC arm received VL results significantly faster than those in the SOC arm (0.1 median days [IQR:0.1-0.2] versus 143.1 median days [IQR:56.0-177.1], respectively; p 0.0001). Participants in the POC arm with confirmed virologic failure versus those in the SOC arm were switched more rapidly to a second-line regimen (0 median days [IQR:0-28] versus 66 days [IQR:63-123], respectively; p = 0.03).POC VL testing resulted in significant improvement in the timeliness of VL result receipt by patients and use for effective HIV clinical management. In patients experiencing VL failure, POC monitoring enabled prompt switching to second-line ART regimens.

Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC versus standard-of-care (SOC) VL monitoring.We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert® or SOC Roche COBAS® (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and health care workers (HCWs) evaluated acceptability.During April 2018 -October 2019, 268 SOC and 273 POC patients enrolled in the trial. VS at1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (p = 0.096) in ITT analysis, and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (p = 0.012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (p = 0.02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCW thought it facilitated patient care.POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care.