Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 8
- 主要终点
- Reduced HIV Viral Load
研究概览
简要总结
This randomized control trial is to test the efficacy of a stepped-care "adaptive" Antiretroviral Therapy (ART) adherence intervention ("Positive STEPS") for HIV infected adolescents and young adults, ages 16 to 29. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.
详细描述
HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to:
- "Positive STEPS" - a stepped care, adherence intervention with integrated technology (2-way daily text messaging aimed at improving ART adherence). If text messaging is not sufficient to overcome the barriers to ART adherence;these individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy.
- Standard of Care comparison group including a brief adherence educational session. This will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.The participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Block randomization
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 16 and 29 years of age
- •HIV-infected (perinatally, transfusion, or behaviorally-acquired)
- •Currently taking or prescribed antiretroviral therapy and: 1) Began taking ART < 3 months ago, OR 2) Has been taking ART for >3 AND has missed one or more doses in the past week or more than 3 doses in the past month.
- •Daily access to a cell phone
- •Has lived in the greater Providence, Boston, or Chicago area greater than three months
- •Self-reports < 90% ART medication adherence in the past month (i.e., missed one or more doses in the past week or more than 3 doses in the past month) at screening
- •Able to speak and understand English
- •Not currently enrolled in another ART-adherence intervention study
- •Willing and able to complete all study visits in person or remotely via video conferencing platform
排除标准
- •Unable to give informed consent due to severe mental or physical illness, cognitive limitation, or substance intoxication at baseline visit
- •HIV-uninfected
- •Not currently on antiretroviral therapy
- •Does not own a cell phone
- •Has lived in the greater Providence, Boston, or Chicago area for less than three months or is planning to move outside the area within the next year
- •Self-reports > 90% ART medication adherence in the past month AND has been taking ART for more than 3 months
- •Unable to speak and understand English
- •Currently enrolled in another ART-adherence intervention study
- •Not willing to and able to complete all study visits in person or remotely via video conferencing platform
结局指标
主要结局
Reduced HIV Viral Load
时间窗: Baseline, 4 month, 8 month, 12 month
Blood specimen collection tested for HIV Viral Load
Daily ART adherence
时间窗: 4 month, 8 month, 12 month
Monitoring of Wisepill device for electronic adherence data
Daily ART Adherence
时间窗: Baseline, 4 month, 8 month, 12 month
Self report via research assessment
ART Medication Level in Hair Sample
时间窗: Baseline, 4 month, 8 month, 12 month
Collection of hair sample to measure level of ART
次要结局
- Engagement in HIV Care(Baseline, 4 month, 8 month, 12 month)
- Medication changes to ART(Baseline, 4 month, 8 month, 12 month)
- Reduced HIV Symptoms(Baseline, 4 month, 8 month, 12 month)
研究者
Matthew Mimiaga, ScD, MPH, MA
Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine
University of California, Los Angeles