一种交互式、高度定制的“视频医生”干预措施对抑制 HIV 病毒载量和留住接受临床护理的 HIV 患者的有效性：一项随机临床试验。
Effectiveness of an Interactive, Highly Tailored "Video Doctor" Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial.
机构信息
RTI International.
Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA.
出版信息
J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):58-67. doi: 10.1097/QAI.0000000000003045. Epub 2022 Jun 27.
BACKGROUND
To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care.
SETTING
Four clinics that deliver HIV primary care.
METHODS
A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well.
RESULTS
There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006].
CONCLUSIONS
Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care.
REGISTRY NAME
Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.
背景
为了确定高度定制的视频医生干预措施“积极健康检查”是否可以提高病毒抑制率和治疗保留率。
设置
提供艾滋病毒初级保健的四家诊所。
方法
采用混合 1 型有效性实施随机试验设计来检验研究假设。不符合病毒抑制标准、新接受治疗或已脱离治疗的参与者（N = 799）被随机分配接受积极健康检查或单独接受标准护理。主要终点是病毒载量抑制，次要终点是 12 个月时的治疗保留率，均采用意向治疗方法进行评估。还检查了基于出生时性别和种族的预先设定的亚组分析。
结果
在主要终点和次要终点上，积极健康检查组（N = 397）和标准护理组（N = 402）之间均无统计学显著差异。然而，预先设定的亚组分析确定了统计学显著的组间差异。接受积极健康检查的男性参与者在 12 个月时实现抑制的可能性高于接受标准护理的男性参与者，调整后的风险比[aRR]（95%置信区间[CI]）= 1.14（1.00 至 1.29），P = 0.046]。对于治疗保留，在积极健康检查组中，年龄最小的 18-29 岁参与者和年龄最大的 60-81 岁参与者在 6 个月就诊时出现就诊间隔的风险较低[调整后的风险比[aRR]（95%CI）= 0.55（0.33 至 0.92），P = 0.024]和[调整后的风险比[aRR]（95%CI）= 0.49（0.30 至 0.81），P = 0.006]。
结论
积极健康检查可能有助于艾滋病毒男性参与者实现病毒抑制，并且年轻和老年患者始终坚持接受艾滋病毒治疗。
注册号
积极健康检查评估试验。试验 ID：1U18PS004967-01。网址：https://clinicaltrials.gov/ct2/show/NCT03292913。
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