Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
研究概览
简要总结
The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).
详细描述
To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study.
To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years
- •Clinic-confirmed HIV diagnosis
- •Currently prescribed or eligible for ART
- •Currently has insurance
- •Self-reported cocaine use in the past 30 days
- •Willing and able to use a cell phone and electronic pill box for the 12-week intervention
排除标准
- •Unable to provide informed consent
- •Verbally or physically threatening to research staff
- •Unable to communicate in either English or Spanish
结局指标
主要结局
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
时间窗: Week 12
Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
时间窗: Week 16
This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.
次要结局
- Percent Change in CD4 Count From Baseline to Week 12(Baseline and End of intervention (Week 12))
- Changes in HIV 1 RNA, QN PCR (Copies/ML)(End of intervention (Week 12))
- Retention in Care(up to End of the study (week 16))