Women's Global Health Imperative, RTI International, Berkeley, California, United States of America.
Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, California, United States of America.
PLoS One. 2023 Dec 22;18(12):e0289919. doi: 10.1371/journal.pone.0289919. eCollection 2023.
BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.
背景:年轻人 HIV 感染率极高,在 HIV 护理连续体的各个阶段都有很高的流失率,而且疾病进展和传播的可能性也更高。实时跟踪和监测抗逆转录病毒治疗 (ART) 依从性的客观指标对于提高研究数据的准确性、支持依从性和改善临床结果至关重要。然而,依从性监测通常依赖于自我报告和回顾性数据,或者需要提供者额外努力来了解个体的依从模式。在这项研究中,我们将使用一种实时客观的依从性测量方法来监测药物服用情况,这种方法不依赖于自我报告或医疗保健提供者进行测量。
方法:“青年终结艾滋病流行(YEHE)”研究将试点一种新的自动化直接观察治疗条件性经济激励(aDOT-CEI)干预措施,以提高加利福尼亚州和佛罗里达州 HIV 病毒载量未受抑制的 HIV 青年(YWH)的 ART 依从性。aDOT 应用程序使用面部识别技术每天记录依从性,然后根据参与者的确认依从性给予经济奖励。我们将招募参与者参加为期 3 个月的试点研究,使用预定义的指标评估 aDOT-CEI 干预措施的可行性和可接受性。在试验期间和之后,试点参与者的一个子样本和参与艾滋病保健基金会(AHF)诊所的工作人员/提供者将参加个别深入访谈,以探索干预和实施的促进因素和障碍。
讨论:YEHE 将提供使用 aDOT-CEI 干预措施来提高未抑制病毒载量的 YWH 依从性的数据。YEHE 研究将记录可行性和可接受性,并探索初步数据,为测试 aDOT-CEI 疗效的试验提供信息。这种干预措施有可能有效提高关键人群的 ART 依从性和病毒学抑制率,这些人群面临着健康差异。
试验注册:试验注册号为 NCT05789875。
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