Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
详细描述
Two-thirds of people living with HIV 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. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. 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.
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 health coaching 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 3 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load > 20 copies/mL);
- •Psychological distress (PHQ-4 score ≥ 2);
- •Recent risky sexual behavior (any unprotected sex OR > 1 sexual partner over the past 6 months)
- •Access to a telephone or cell phone
排除标准
- •Unwilling or unable to provide informed consent
- •Cognitive impairment
- •Non-English speaking
- •Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
- •Enrolled in another behavioral trials
- •Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
- •Severe hearing impairment not allowing phone delivery
- •Suicidal ideation
- •Planning to move out of the area within the study period
- •Clinic provider advising against recruitment in the study.
结局指标
主要结局
Feasibility of Intervention
时间窗: post-intervention, 9 to 10 weeks after baseline
Feasibility - as indicated by the number of patients attending at least 50% of sessions
次要结局
- Acceptability of the Intervention(post-intervention, 9 to 10 weeks after baseline)
- Antiretroviral Medication Adherence(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
- Self-reported Sexual Risk Behavior(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
- Five Facet Mindfulness Questionnaire(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
- Perceived Stress Scale(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
- Barratt Impulsiveness Scale(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
- Patient Health Questionnaire(Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline)
研究者
Michael P. Carey
Professor and Director, Centers for Preventive and Behavioral Medicine, The Miriam Hospital
The Miriam Hospital