Optimizing HIV Care for Patients With Substance Use Disorders Using Predictive Analytics in a Mobile Health Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use.
研究概览
简要总结
It is now well-accepted that lowering community-level viral load through expansion of antiretroviral therapy (ART) can reduce HIV transmission among people who use drugs. However, achieving durable viral suppression among patients with substance use disorders is a major challenge for providers and health systems. This study aims to adapt and implement an existing mobile health (mHealth) system, A-CHESS (Addiction Comprehensive Health Enhancement Support System) to improve care for HIV patients with substance use disorders.
详细描述
Patients with substance use disorders are continuously at risk for relapse and other disruptive life events, which may lead to lapses in antiretroviral treatment and subsequent viral rebound, thereby increasing their level of infectivity. Behaviors that place others at risk for HIV transmission such as sharing drug paraphernalia and unprotected sex may also increase during these periods of social and behavioral instability.
Various biomedical, behavioral, and structural interventions have been used to prevent lapses in HIV care or minimize their impact when they occur. A potentially transformative strategy would be the one that makes novel use of ubiquitous technology and the existing clinical workforce to provide highly-effective, tailored support to the patients at greatest risk, at the time and place it is needed the most.
This study has 2 phases:
Phase I has been completed and it was an observational study, not a clinical trial. Patients who volunteered were recruited to use the mobile phone app to enter data, but it was not intended to improve their health or health care. The data collected during phase 1 will be used to inform the intervention in phase 2, where the study team hope to use the system to improve patient care.
Phase 2 will conduct a single-arm implementation study (with historical controls) of A-CHESS when implemented in 2 high-volume HIV clinics, providing evidence describing the effectiveness and durability of an mHealth strategy for maintaining viral suppression among patients with substance use disorders treated with ART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18+ years old
- •Documentation of HIV infection
- •Able to read and write in English
- •A history of substance use disorder, defined as one or more of the following:
- •A positive result on one or more SUD screening tests (see "Screening," below), reflecting substance use during the prior year.
- •Current participation in a substance abuse treatment program, including medication assisted treatment for SUD, or regular (at least monthly) participation in SUD-oriented support groups.
- •A lifetime history of problematic drug or alcohol use AND having been incarcerated in the past year, regardless of the date of last substance use.
排除标准
- •Individuals who are under 18, are not HIV-positive, who have no history of alcohol or drug misuse, or cannot read and write in English
- •Individuals who are prohibited from using the internet on any device as a condition of criminal justice supervision
- •Individuals who cannot demonstrate competency in using the A-CHESS interface on a smartphone or web browser after a standard period of training by a research staff member
结局指标
主要结局
Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use.
时间窗: Up to 12 months
Viral suppression will be measured each 6 months period. HIV RNA\< 200 copies/mL reflects viral suppression per protocol.
次要结局
- Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use.(up to 12 months)
- Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.(up to 12 months)
- Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.(up to 12 months)