跳至主要内容
临床试验/NCT03758066
NCT03758066已完成不适用

PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS

Dimagi Inc.2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Dimagi Inc.
入组人数
65
试验地点
2
主要终点
Appointment Adherence Rate

研究概览

简要总结

While major advancements in medical technology over the past decade have significantly improved the life expectancy of persons infected with human immunodeficiency virus (HIV), HIV-positive youth today face new barriers to the treatment of HIV as a chronic, manageable illness. The mobile system proposed will help improve linkage to care through mobile technology support for the case management of youth living with HIV. Results of this project will determine the impact of this system on case management processes and outcomes and have implications for the care of youth living with other chronic, complex illnesses.

详细描述

With the advancement of medical treatments, which has contributed to the overall decrease in opportunistic infections and deaths related to human immunodeficiency virus (HIV) in youth, there is a need to ensure that youth living with HIV (YLH) are linked to and engaged in care to successfully achieve viral suppression. While an increasing number of mobile health (mHealth) technologies have been designed to address HIV prevention and care, a critical gap in innovation remains in tools designed to address the specific needs of YLH. In a Phase I project, investigators demonstrated the acceptability and feasibility of a user-centered prototype design of PlusCare, an mHealth application that can be used by YLH and their case managers (CMs) to support HIV care. Results of Phase I suggest that PlusCare could facilitate multi-disciplinary, team-based case management of YLH by supporting the sharing and signing of documents remotely, automation of adherence reminders, sharing of lab results, alerts CMs about program requirements related to age and developmental milestones, streamlining of communication between multiple members of a patient's case management team and the patient, and offering accessibility to data from multiple modalities. In this Phase II project, investigators will conduct a mixed methods, non-randomized pre-post study with CMs (N=20) and YLH patients (N=70) to examine the use of PlusCare on case management processes and health outcomes (i.e., HIV viral load, medical visit frequency and gaps) in 3 different case management programs at 2 different clinical study site settings. An initial cost analysis will be performed to assess potential cost effectiveness. Results of these Phase I and II projects will inform the development of a product that can be used in multiple case management settings and prepare PlusCare for future commercialization. Results have implications for future development of PlusCare to serve the broader HIV population (YLH aged 25-34 years old and at-risk individuals) as well as youth living with other chronic health conditions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • between 13-25 years old
  • HIV positive
  • enrolled in treatment at a participating study site
  • owns or has ability to access a smartphone (e.g., iPhone, Android) for one year

排除标准

  • Non-English speaker or
  • Visually/hearing impaired
  • CASE MANAGERS:
  • Inclusion Criteria:
  • Actively employed at a participating study site
  • Performs case management duties with HIV-positive patients aged 13-25 years.
  • Exclusion Criteria:

结局指标

主要结局

Appointment Adherence Rate

时间窗: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of median appointment adherence ratio between pre and post time points, i.e., (Actual completed appointments) / (Expected appointments) where expected appointments includes completed appointments, no shows, and cancellations

CD4 Cell Count

时间窗: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of average CD4 cell count (cells/mm\^3) between pre and post time points

Viral Load

时间窗: 1 year prior to baseline (pre), 1 year post-baseline (post)

Comparison of average viral load (copies/mL) between pre and post time points

次要结局

  • Proximal Outcomes (Monthly Medication Adherence Item)(Monthly)
  • Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey(1 year (Baseline, 6-month, 12-month))
  • Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey(1 year (Baseline, 6-month, 12-month))
  • System Usability (User Satisfaction): System Usability Scale(1 year)

研究者

发起方
Dimagi Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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