Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 433
- 试验地点
- 9
- 主要终点
- Incremental Cost per Quality-Adjusted Life-Year Gained through Increased Antiretroviral Adherence
研究概览
简要总结
The current protocol aims to enroll up to 806 participants from 8 study sites in a clinic-supported intervention which will connect them to Vivent Health care team and a cohort of peer mentors for a year-long intervention period to support patient HIV care to maintain viral suppression and clinic appointments.
详细描述
This protocol describes the implementation phase of a 5-year NIH-funded research project designed to evaluate the effectiveness of an innovative clinic-level intervention featuring an evidence-based, HIPAA-compliant mobile health (mHealth) application ("Connections," a smartphone app operated by the company CHESS Health) and peer-driven social support.
The goal of this project is to implement and evaluate an evidence-based mHealth system to improve HIV viral suppression and reduce missed clinic visits within a multi-site, comprehensive HIV care program. Connections is a mobile health app developed by CHESS Health to support patients with substance use disorders.
The investigators hypothesize that implementation of an adapted version of Connections within an established network of HIV clinical practices will reduce the occurrence of the primary outcome of virologic failure and the secondary outcome of missed clinic appointments.
The specific aims are:
- To test the effectiveness of Connections using a stepped-wedge randomized trial.
- To evaluate the implementation of Connections within the HIV Medical Home Model. Using the RE-AIM framework, we will analyze patient-level, provider-level, and clinic-level factors that influence the reach, implementation, adoption, and maintenance of Connections in HIV practices.
- To systematically measure costs of implementation of Connections in relationship to its benefits related to preventing virologic failure and missed clinic appointments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Able to read, write and speak English
- •Receives HIV Disease Care at Vivent Health
- •At risk for poor engagement in HIV care, as evidenced by any one of the following:
- •Prior missed clinic visits
- •Poor adherence to medical treatment defined as 2 or more missed doses of medication in a month
- •Unhealthy alcohol or other substance use, as evidenced by a diagnosis of substance use disorder on the patient's problem list, a prior referral to alcohol or substance abuse services, or answering "yes" to one or both of the following screening questions:
- •Has drinking alcohol or using drugs (including marijuana) ever caused problems in your life, such as damaging relationships, causing you to not meet obligations at work, or getting in trouble with the law?
- •Are you currently participating in any treatment or counseling because of problems caused by drug use? This can include groups like N. A., or one-on-one interaction with a doctor or therapist.
排除标准
- •Individuals who do not currently have a smartphone or are unwilling to obtain a smartphone will not be able to participate in this study.
- •People who are unwilling to download and activate the Connections app.
- •People with cognitive or other impairment that precludes the capacity to consent.
研究组 & 干预措施
Group 1: mHealth Implementation
First 2 sites begin enrollment. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.
干预措施: Connections App (Device)
Group 2: mHealth Implementation
Next 2 sites begin enrollment 6 months after Group 1. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.
干预措施: Connections App (Device)
Group 3: mHealth Implementation
Next 2 sites begin enrollment 6 months after Group 2. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.
干预措施: Connections App (Device)
Group 4: mHealth Implementation
Next 2 sites begin enrollment 6 months after Group 3. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.
干预措施: Connections App (Device)
结局指标
主要结局
Incremental Cost per Quality-Adjusted Life-Year Gained through Increased Antiretroviral Adherence
时间窗: up to 12 months
Setup, operating, and healthcare costs of implementation in relationship to its effectiveness in preventing virologic failure and missed clinic appointments. The primary incremental cost-effectiveness ratio (ICER) will be the incremental cost per quality-adjusted life-year gained through increased antiretroviral adherence (Aim 3)
Occurrence of Virologic Failure
时间窗: baseline and 12 months for each clinic
Using the stepped-wedge design to assess Effectiveness, each site will function as its own control or "usual care" group prior to implementation of Connections. (Aim 1)
Percentage of Vivent Health HIV patients who have downloaded and used Connections
时间窗: up to 4 years
The primary Reach measure will be the percentage of Vivent Health HIV patients who have downloaded and used Connections, including sex, racial, and ethnic characteristics. (Aim 2)
次要结局
- Number of "meaningful use" weeks(up to 12 months)
- Number of Missed Clinic Appointments(baseline and 12 months for each clinic)
- Days of "meaningful use" per week(up to 12 months)
- Percent Participant Follow up in the 6-month post-intervention period(clinic follow up in the 6-month post-intervention period (up to 18 months for participant))
- Change in "meaningful use" after a private message(before and after messaging (any time up to 12 months))