The Wise App Trial for Improving Health Outcomes in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in ART Adherence - Clever Cap
研究概览
简要总结
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
详细描述
Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Have a diagnosis of HIV
- •Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
- •Be able to communicate and read in English or Spanish
- •Live in the US
- •Have a smartphone
- •Be taking ART medications
排除标准
- •Participation in any other mobile app study for PLWH, including text messaging studies
- •Diagnosis of a clinical problem that would preclude someone from using a smartphone
结局指标
主要结局
Change in ART Adherence - Clever Cap
时间窗: Up to 6 months
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).
次要结局
- Change in Number of Primary Care Visits(Baseline, 3 months, and 6 months)
- Change in Cluster of Differentiation 4 (CD4) Count(Baseline, 3 month follow up, and 6 month follow up)
- Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire(Baseline, 3 month follow up and 6 month follow up)
- Change in Score on the Center for Adherence Support Evaluation (CASE) Index(Baseline, 3 month follow up, and 6 month follow up)
- Change in Viral Load(Baseline, 3 month follow up, and 6 month follow up)
- Change in Score on the Engagement With Health Care Provider Scale(Baseline, 3 months, and 6 months)
研究者
Rebecca Schnall, RN, MPH, PhD
Principal Investigator
Columbia University