PositiveLinks for Youth (PL4Y) for Texas: Effectiveness, Feasibility, and Acceptability of mHealth to Improve Care Outcomes for Young Adults With HIV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Virologic Suppression
研究概览
简要总结
The goal of this interventional clinical trial is to test an an app, PL4Y, installed on a mobile smartphone to see if it can help participants aged 18-29 years who have HIV achieve success with their HIV care and feel supported by their clinic community.
The first 6 months will be standard of care, after which participants will continue to meet virtually with their health care providers and will also be provided with and taught how to use the app. The standard of care clinic visits will continue as before and virtual visits using the app will be started and continue for abot 18 months.
Adherence to medications Appointment reminders Provide secure communication with providers
Provide a support group in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:
[primary hypothesis or outcome measure 1]? [primary hypothesis or outcome measure 2]?
If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
详细描述
The overall objective of this proposal is to implement and rigorously test an existing mHealth care engagement intervention, PL4Y, in a six clinic network in Texas. The investigators will use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform a type 1 hybrid study, assessing effectiveness of PL4Y alongside measures of acceptability, feasibility, and sustainability. The study has two main components:
- A cluster randomized longitudinal staircase trial across six clinics in Texas
- Qualitative assessment, using semi-structured interviews and focus groups, of acceptability and feasibility of PL4Y implementation in the clinics
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 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-29yo living with HIV
- •Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos,
- •English speaking
- •Able to participate in the informed consent process.
- •Access to a personal smartphone with a data plan capable of supporting the PL4Y app. The phone must be password protected and not shared with others for confidentiality purposes.
- •Interviews only- A stakeholder in one of the network clinics
- •18 years or older
- •able to participate in the informed consent process
排除标准
- •They cannot provide consent
- •Unwilling or unable to complete virtual study visits
研究组 & 干预措施
mHealth Intervention group
18-29yos with HIV who are in care in one of the participating clinics.
干预措施: PositiveLinks for Youth Smartphone App (Behavioral)
结局指标
主要结局
Virologic Suppression
时间窗: Baseline to 12 months (+/- 3 months)
HIV-1 Plasma RNA level \<200 copies/ml at 12 months
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline to Study End (approximately 18 months))
- HIV Stigma Scale Survey (HIVSS)(Baseline to Study End (approximately 18 months))
- National Institute of Drug Abuse (NIDA) - Modified ASSIST(Baseline to study end (approximately 18 months))
- System Usability Survey(Month 12 and Month 18)
- HIV Care Engagement(Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos))
研究者
Barbara Taylor
Professor
The University of Texas Health Science Center at San Antonio