Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Messaging and Cell Phone Support Embedded Within the Sequential Multiple Assignment Randomized Trial (SMART) Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Undetectable Viral Load
研究概览
简要总结
The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.
详细描述
The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS).
The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.
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
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV diagnosis
- •Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
- •ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
- •Sole owner of device capable of sending/receiving calls and text messages
- •Willingness to permit research team to communicate with their HIV care provider team
排除标准
- •Mental, physical, or emotional capacity prevents completion of protocol as written
- •Inability to understand written/spoken English
- •Concurrent participant in any adherence behavioral research intervention
结局指标
主要结局
Undetectable Viral Load
时间窗: baseline, month 3, month 6, month 9, and month 12
Percent of participants that have an undetectable HIV Viral Load.
Medication Adherence Rate - 7 Day
时间窗: baseline, month 3, month 6, month 9, and month 12
Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Medication Adherence - 30 Days
时间窗: baseline, month 3, month 6, month 9, and month 12
Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
次要结局
未报告次要终点
研究者
Sylvie Naar
Principal Investigator
Florida State University