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

 描述(申请人提供)：强烈建议艾滋病毒携带者坚持抗逆转录病毒疗法(ART)，以减少艾滋病毒相关的发病率，延长寿命，并降低传染性。还强烈建议他们避免危险的性行为，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)使这些人很难遵循这些医学建议。初步研究表明，正念训练(MT)可以帮助艾滋病毒携带者更有效地应对压力。虽然令人鼓舞，但这项研究有方法上的局限性，而且关于MT对ART依从性和减少性风险的可能影响的信息有限或没有。此外，抗逆转录病毒治疗通常采取的形式(即每周小组会议、周末讲习班)对于艾滋病毒携带者来说是不可行的，因为他们收入低得不成比例，而且往往缺乏参与传统抗逆转录病毒治疗所需的资源。这项R34探索性临床试验的目标是确定电话递送MT的可行性和可接受性，并获得其对ART依从性和减少性风险的有效性的初步证据。在进行R01支持的第三阶段随机临床试验以正式测试MT对ART依从性和减少性风险的有效性之前，有必要完成这项研究。与PAR-14-182一致，我们提出了形成阶段和试点阶段。形成阶段将涉及使我们现有的以电话为基础的MT干预措施适应艾滋病毒背景(目标1)，开发一个时间和注意力匹配的比较条件(目标2)，并完善我们的评估方案(目标3)。在形成阶段，我们将最终确定研究方案和同意，制定操作手册，并获得监管部门的批准。下一步，在试点阶段，我们将实施干预措施和评价方案，以确定其可行性和可接受性(目标4)。HIV+门诊患者(N=50)将被招募，在基线上进行评估，随机分配到MT组(n=25)或对照干预组(n=25)，并在干预后和3个月的随访时重新评估。可行性和可接受性将使用混合方法进行评估。我们还将获得对ART坚持和危险性行为的影响大小的初步估计，以及正念训练的假想中介(即抑郁、感知到的压力、冲动)。我们提出了几项创新来改进先前的研究。首先，我们将使用一种新颖且可扩展的方法来交付MT。其次，我们将探索MT对于坚持抗逆转录病毒治疗和降低性风险的有用性，这些目标在之前的MT研究中很少涉及。第三，我们将针对不遵守(例如抑郁症状)和危险性行为(例如冲动)的可修改决定因素。第四，我们将解决现有研究的局限性，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；使用自我报告的、客观的和生物学的方法来衡量ART依从性和风险性行为。

 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.