Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior among Persons Living with HIV

 描述（由申请人提供）：强烈建议艾滋病毒感染者坚持抗逆转录病毒治疗（ART），以减少艾滋病毒相关的发病率，延长寿命，降低传染性。他们还被强烈建议避免危险的性行为，以避免艾滋病毒双重感染和其他性传播感染，并减少将艾滋病毒传播给未感染的伴侣的可能性。然而，生活压力及其后果（例如，抑郁症）使这些人难以遵循这些医疗建议。初步研究表明，正念训练（MT）可以帮助艾滋病毒感染者更有效地科普压力。虽然令人鼓舞，但这项研究存在方法上的局限性，关于MT对ART依从性和性风险降低的可能影响的信息有限或没有。此外，MT通常以格式（即，每周小组会议、周末讲习班），而这些活动对艾滋病毒感染者来说是不可行的，因为他们的收入低得不成比例，往往缺乏参加传统MT所需的资源。这项R34探索性临床试验的目的是确定电话传递MT的可行性和可接受性，并获得其对ART依从性和降低性风险的疗效的初步证据。在进行R 01支持的III期随机临床试验之前，必须完成这项研究，以正式测试MT对ART依从性和性风险降低的疗效。与PAR-14-182一致，我们提出了一个形成和试点阶段。形成阶段将涉及使我们现有的基于电话的MT干预适应艾滋病毒背景（目标1），开发时间和注意力匹配的比较条件（目标2），以及改进我们的评估方案（目标3）。在形成阶段，我们将最终确定研究方案和同意书，制定操作手册，并获得监管部门的批准。接下来，在试点阶段，我们将实施干预措施和评估协议，以确定其可行性和可接受性（目标4）。将招募HIV阳性门诊患者（N = 50），在基线时进行评估，随机分配至MT组（n = 25）或对照干预组（n = 25），并在干预后和3个月随访时进行重新评估。可行性和可接受性将采用混合方法进行评估。我们还将获得对ART依从性和危险性行为以及正念训练的假设介质（即，抑郁、感知压力、冲动性）。我们提出了一些创新，以改善先前的研究。首先，我们将使用一种新颖且可扩展的方法来交付MT。其次，我们将探讨MT对ART依从性和性风险降低的有用性，这些目标在以前的MT研究中很少涉及。第三，我们将针对不遵守的可变决定因素（例如，抑郁症状）和危险性行为（例如，冲动）。第四，我们将通过对高危人群进行抽样，采用时间和注意力匹配的比较条件，以及使用自我报告的、客观的和生物学的抗逆转录病毒疗法依从性和危险性行为的措施来解决现有研究的局限性。

 DESCRIPTION (provided by applicant): People living with HIV are strongly advised to adhere to antiretroviral therapy (ART) in order to decrease HIV-related morbidities, increase longevity, and decrease infectiousness. They are also strongly advised to avoid risky sex behaviors to avoid HIV super-infection and other sexually transmitted infections, and to reduce the likelihood of transmitting HIV to an uninfected partner. However, life stress and its consequences (e.g., depression) make it challenging for these individuals to follow these medical recommendations. Preliminary research suggests that mindfulness training (MT) can help people living with HIV cope more effectively with stress. Although encouraging, this research has methodological limitations, and there is limited or no information regarding the possible effect of MT on ART adherence and sexual risk reduction. Further, MT has typically been delivered in formats (i.e., weekly group sessions, weekend workshops) that are infeasible for people living with HIV, who are disproportionately low-income and often lack the resources needed to participate in traditional MT. The goals of this R34 exploratory clinical trial are to determine the feasibility ad acceptability of phone-delivered MT, and to obtain preliminary evidence of its efficacy for ART adherence and sexual risk reduction. Completion of this research is necessary prior to conducting a R01-supported, Phase III randomized clinical trial to formally test the efficacy of MT for ART adherence and sexual risk reduction. Consistent with PAR-14-182, we propose a formative and a pilot phase. The formative phase will involve adapting our existing telephone-based MT intervention to the HIV context (Aim 1), developing a time- and attention-matched comparison condition (Aim 2), and refining our assessment protocol (Aim 3). During the formative phase, we will finalize the study protocols and consents, develop a manual of operations, and obtain regulatory approvals. Next, during the pilot phase, we will implement both interventions and the evaluation protocol to determine their feasibility and acceptability (Aim 4). HIV+ outpatients (N = 50) will be recruited, assessed at baseline, randomly assigned to MT (n = 25) or to a control intervention (n = 25), and re-assessed at post-intervention and at a 3-month follow-up. Feasibility and acceptability will be assessed using mixed methods. We will also obtain preliminary estimates of effect sizes for ART adherence and risky sex behavior as well as for the hypothesized mediators of mindfulness training (i.e., depression, perceived stress, impulsivity). We propose several innovations to improve upon prior research. First, we will use a novel and scalable method to deliver MT. Second, we will explore the usefulness of MT for ART adherence and sexual risk reduction, targets rarely addressed in prior MT research. Third, we will target modifiable determinants of non- adherence (e.g., depressive symptoms) and risky sex (e.g., impulsivity). Fourth, we will address limitations of the extant research by sampling at-risk persons; employing a time- and attention-matched comparison condition; and using self-reported, objective, and biological measures of ART adherence and risky sex.