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

正念训练可提高艾滋病毒感染者的抗逆转录病毒治疗依从性并减少危险行为

基本信息

批准号：
8990166
负责人：
MICHAEL P CAREY
金额：
$ 14.6万
依托单位：
MIRIAM HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8990166
关键词：
Address Adherence Adult Advocate Alcohol or Other Drugs use American Anus Attention Behavior Biological Cardiac Cellular Phone Clinical Clinical Trials Consent Contracts Coping Behavior Data Development Disease Distress Educational Intervention Educational workshop Enrollment Evaluation Focus Groups Future Goals HIV HIV Infections Health Healthcare Impulsivity Incidence Individual Infection Intervention Interview Lead Life Life Stress Longevity Low income Manuals Measures Mediation Mediator of activation protein Medical Mental Depression Methods Morbidity - disease rate Outcome Outpatients Patient Self-Report Patients Persons Phase Play Prevalence Process Protocols documentation Provider Publishing Randomized Randomized Clinical Trials Randomized Controlled Trials Recommendation Recruitment Activity Reporting Research Research Project Grants Research Training Resources Risk Risk Behaviors Risk Reduction Role Safe Sex Sampling Self-Administered Sex Behavior Sexually Transmitted Diseases Stress Suggestion Telephone Testing Time Training Training Programs Transportation Viral Viral Load result Work antiretroviral therapy avoidance of risky sexual behavior base computer program coping cost depressive symptoms design efficacy testing follow-up improved innovation medication compliance men who have sex with men mindfulness mortality novel operation pill post intervention premature primary outcome programs psychological distress public health relevance resistant strain response secondary outcome sex sex risk skills therapy adherence therapy resistant

项目摘要

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.

描述（由适用提供）：强烈建议患有艾滋病毒的人遵守抗逆转录病毒疗法（ART），以减少与HIV相关的病态，增加寿命并降低感染性。还建议他们避免有风险的性行为，以避免HIV超级感染和其他性传播感染，并减少向未感染的伴侣传播HIV的可能性。但是，生命压力及其后果（例如抑郁症）使这些人遵循这些医疗建议的挑战。初步研究表明，正念训练（MT）可以帮助艾滋病毒患者更有效地应对压力。尽管令人鼓舞，但这项研究具有方法论上的局限性，并且关于MT可能对艺术依从性和降低性风险的影响的信息有限或没有信息。此外，MT通常以对艾滋病毒的人来说是不可行的，这些格式（即每周的小组会议，周末研讨会）是不可行的，他们的低收入性低，并且常常缺乏参加传统MT所需的资源。这项R34探索性临床试验的目标是确定电话传递MT的可行性可接受性，并获得其对艺术依从性和降低性风险的有效性的初步证据。在进行R01支持的，III期随机临床试验之前，必须完成这项研究的完成，以正式测试MT对艺术依从性和降低性风险的效率。与PAR-14-182一致，我们提出了一个形成阶段和试点阶段。形成阶段将涉及将我们现有的基于电话的MT干预调整到艾滋病毒环境（AIM 1），开发时间和注意力匹配的比较条件（AIM 2）以及完善我们的评估协议（AIM 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批准。接下来，在试点阶段，我们将同时实施干预措施和评估协议，以确定其可行性和可接受性（AIM 4）。 HIV+门诊患者（n = 50）将在基线时进行评估，随机分配给MT（n = 25）或对照干预措施（n = 25），并在干预后和3个月的随访中重新评估。可行性和可接受性将使用混合方法评估。我们还将获得对艺术依从性和风险性行为的效果大小的初步估计，以及假设的正念训练介体（即抑郁，感知的压力，冲动）。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而可扩展的方法来提供MT。其次，我们将探索MT在先前的MT研究中很少解决的目标对艺术依从性和性风险的有用性。第三，我们将针对不遵守性的可修改决定者（例如抑郁症状）和危险的性别（例如冲动性）。第四，我们将通过抽样高危人来解决广泛研究的局限性；采用时间和注意力匹配的比较条件；并使用自我报告，客观和生物学的艺术依从性和风险性行为。