Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Faculty of Nursing, Université de Montréal, Montreal, QC, Canada.
JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733.
Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l'immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally.
We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT).
This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups.
The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4).
This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities.
ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340.
服用抗逆转录病毒疗法(ART)是 HIV 感染者日常生活的一部分。已经提出了不同的电子健康(eHealth)辅助常规护理的措施,以支持最佳的药物依从性。一个名为 HIV 治疗、虚拟护理协助和教育或 VIH-TAVIE(法语版为 Virus de l'immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement)的基于网络的干预措施被开发出来,旨在使 HIV 感染者能够最佳地管理他们的 ART 和症状。
我们旨在通过一项基于网络的随机对照试验(RCT)评估 VIH-TAVIE 的有效性。
这项 RCT 完全基于网络,包括招募、同意授权、问卷调查完成和干预暴露(与 VIH-TAVIE 咨询[实验组]或网站[对照组])。要符合研究条件,HIV 感染者必须年满 18 岁,接受 ART 治疗至少 6 个月,能够上网并具备网络知识。参与者被随机分配到实验组(n=45)或对照组(n=43)。主要结局是 ART 依从性。次要结局包括药物摄入、症状相关不适、技能和策略以及社会支持方面的自我效能感。所有结局都在以下三个时间点通过自我管理的基于网络的问卷进行测量:基线和 3 个月和 6 个月后。建立了一个广义线性混合模型来评估两组中 ART 依从性随时间的变化。
该样本包括 88 名参与者,其中 73 名(83%)为男性。参与者的中位年龄为 42 岁。参与者被诊断出患有 HIV 的中位时间为 7 年前(IQR 3-17),接受 ART 治疗的中位时间为 5 年(IQR 2-12)。两组基线时治疗依从性高的参与者比例也很高(实验组 34/41,83%;对照组 30/39,77%)。参与者还报告了较高的治疗依从性、较高的自我效能感和较高的技能;感知到良好的社会支持;以及症状相关的不适较低。分析显示,两组间 ART 依从性无差异(OR 1.9,95%CI 0.6-6.4)。
这项研究强调了在 HIV 感染者中开展完全基于网络的 RCT 所面临的挑战和经验教训。挑战涉及到以下三个层面的 HIV 感染者的参与:开始基于网络的研究(招募)、完成基于网络的干预(参与)和继续研究(保留)。结果为如何开展旨在发展和加强个人技能和能力的电子健康干预措施的基于网络的评估研究提供了现有知识体系的补充。
ClinicalTrials.gov NCT01510340;https://clinicaltrials.gov/ct2/show/NCT01510340。