Salmoirago-Blotcher Elena, Rich Carla, Rosen Rochelle K, Dunsiger Shira, Rana Aadia, Carey Michael P
Centers for Behavioral and Preventive Medicine, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02903, United States; Department of Medicine, The Warren Alpert Medical School of Brown University, United States.
Centers for Behavioral and Preventive Medicine, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02903, United States.
Contemp Clin Trials. 2017 Feb;53:162-170. doi: 10.1016/j.cct.2016.12.016. Epub 2016 Dec 23.
Two-thirds of people living with HIV (PLWH) show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. To allay distress and lessen impulsivity, mindfulness training (MT) can be helpful. In this trial, we will investigate the utility of phone-delivered MT for PWLH. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.
METHODS/DESIGN: Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to an attention-control intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3months post-intervention.
MT has great potential to help PLWH to manage stress, depressive symptoms, and impulsivity. Positive changes in these antecedents are expected to improve safer sex practices and ART adherence. If results from this exploratory trial support our hypotheses, we will conduct a large RCT to test (a) the efficacy of MT on ART adherence and safer sex practices and (b) the hypothesis that improved ART adherence and safer sex will reduce viral load, and decrease the incidence of sexually transmitted infections, respectively.
三分之二的艾滋病毒感染者（PLWH）对抗逆转录病毒疗法（ART）的依从性欠佳，三分之一的人有危险性行为。不依从和危险性行为均与情绪困扰和冲动性有关。为缓解困扰并减少冲动性，正念训练（MT）可能会有所帮助。在本试验中，我们将研究通过电话提供的正念训练对艾滋病毒感染者的效用。主要结局包括通过电话提供正念训练的可行性和可接受性；次要结局是对正念训练在抗逆转录病毒疗法依从性、更安全性行为及其假定前提方面疗效的评估。
方法/设计：五十名参与者将被纳入这项平行组随机临床试验（RCT）。从一家艾滋病毒治疗诊所招募的门诊患者将被随机（1:1比例）分为正念训练组或注意力控制干预组；两种干预均通过每周8次电话进行。将在基线、干预后和干预后3个月测量抗逆转录病毒疗法依从性（自我报告测量和未通知的电话药丸计数）、性行为（自我报告和生物标志物）、正念、抑郁、压力和冲动性。
正念训练有很大潜力帮助艾滋病毒感染者管理压力、抑郁症状和冲动性。预计这些前提方面的积极变化将改善更安全性行为和抗逆转录病毒疗法依从性。如果这项探索性试验的结果支持我们的假设，我们将进行一项大型随机对照试验，以检验（a）正念训练在抗逆转录病毒疗法依从性和更安全性行为方面的疗效，以及（b）改善抗逆转录病毒疗法依从性和更安全性行为将分别降低病毒载量和性传播感染发生率的假设。
