Boyce Ross M, Ndizeye Ronnie, Ngelese Herbert, Baguma Emmanuel, Shem Bwambale, Rubinstein Rebecca J, Rockwell Emmanuel, Lotspeich Sarah C, Shook-Sa Bonnie E, Ntaro Moses, Nyehangane Dan, Wohl David A, Siedner Mark J, Mulogo Edgar M
Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. doi: 10.1371/journal.pgph.0001678. eCollection 2023.
Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2-7). Time from sample collection to result was 51 days (IQR = 45-62) for samples sent to the central laboratory and 0 days (IQR = 0-0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.
在撒哈拉以南非洲地区，各种障碍持续限制着病毒载量（VL）监测的可及性，对艾滋病毒疫情的防控产生了不利影响。本研究的目的是确定在乌干达农村地区一个典型的基层（即三级）卫生中心，是否具备实现快速分子技术潜力所需的系统和流程。在这项开放标签的试点研究中，参与者在中央实验室（即护理标准）和现场使用GeneXpert HIV-1检测法进行了平行VL检测。主要结局是每个临床日完成的VL检测数量。次要结局包括从样本采集到在诊所收到结果的天数，以及从样本采集到患者收到结果的天数。2020年8月至2021年7月，我们共招募了242名参与者。Xpert平台上每日检测的中位数为4次（四分位间距 = 2 - 7）。送往中央实验室的样本从采集到出结果的时间为51天（四分位间距 = 45 - 62），而在卫生中心进行的Xpert检测为0天（四分位间距 = 0 - 0.25）。然而，很少有参与者选择通过其中一种快速选项接收结果，这导致两种检测方法在患者接收结果的时间上相近（89天对84天，p = 0.07）。在乌干达农村地区的基层卫生中心实施快速、近床边的VL检测似乎是可行的，但促进快速临床反应以及影响患者对结果接收偏好的干预措施还需要进一步研究。试验注册：ClinicalTrials.gov标识符：NCT04517825，于2020年8月18日注册。可在以下网址获取：https://clinicaltrials.gov/ct2/show/NCT04517825 。
