Section of Public and Population Health, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.
Division of Infectious Diseases, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
AIDS Behav. 2023 Dec;27(12):4041-4051. doi: 10.1007/s10461-023-04118-9. Epub 2023 Jul 4.
The COVID-19 pandemic had a significant impact on vulnerable populations, including people living with HIV. California implemented a coronavirus lockdown (stay-at-home order) in March 2020, which ended in January 2021. We evaluated the pandemic's impact on both clinical outcomes of HIV RNA viral load (VL) and retention rate in a randomized clinical trial conducted from May 2018 to October 2020. The intervention group took co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) pills from baseline through week 16. The IS system has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. Both the IS and usual care (UC) groups were followed monthly for 28 weeks. Longitudinal mixed-effects models with random intercept and slope (RIAS) were used to fit log VL and self-reported adherence. The sample size of the study was 112 (54 in IS). Overall, the retention rate at week 28 was 86%, with 90% before the lockdown and 83% after the lockdown. The lockdown strengthened the associations between adherence and VL. Before the lockdown, a 10% increase in adherence was associated with a 0.2 unit decrease in log VL (β = -1.88, p = 0.004), while during the lockdown, the association was a 0.41-unit decrease (β = -2.27, p = 0.03). The pandemic did not have a significant impact on our adherence-focused intervention. Our findings regarding the intervention effect remain valid. TRIAL REGISTRATION NUMBER: NCT02797262. Date registration: September 2015.
COVID-19 大流行对包括艾滋病毒感染者在内的弱势群体产生了重大影响。加利福尼亚州于 2020 年 3 月实施了冠状病毒封锁（居家令），并于 2021 年 1 月结束。我们评估了大流行对 HIV RNA 病毒载量（VL）和保留率的临床结果的影响，这是一项在 2018 年 5 月至 2020 年 10 月进行的随机临床试验。干预组从基线到第 16 周服用共包封的抗逆转录病毒药物（ARV）和可摄入传感器（IS）药丸。IS 系统具有使用传感器贴片、移动设备和支持软件实时监测依从性的能力。IS 和常规护理（UC）组均在 28 周内每月随访。使用具有随机截距和斜率（RIAS）的纵向混合效应模型拟合 log VL 和自我报告的依从性。研究的样本量为 112 名（IS 组 54 名）。总体而言，第 28 周的保留率为 86%，封锁前为 90%，封锁后为 83%。封锁加强了依从性与 VL 之间的关联。在封锁之前，依从性增加 10%与 log VL 降低 0.2 个单位相关（β=-1.88，p=0.004），而在封锁期间，相关性降低了 0.41 个单位（β=-2.27，p=0.03）。大流行对我们以依从性为重点的干预措施没有重大影响。我们关于干预效果的发现仍然有效。试验注册号：NCT02797262。登记日期：2015 年 9 月。
