PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Viral plasma load measurement
研究概览
简要总结
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
详细描述
After completing enrollment and informed consent, participants will be randomly assigned to PL4Y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. There is no blinding in this study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Confirmed HIV infection
- •Recent diagnosis of HIV (within the past 6 months) OR be virologically unsuppressed (>1000 copies/ml) OR disengaged from HIV care (< 2 visits/last 12 months > 90 days apart)
排除标准
- •Cannot consent
- •Unwilling to come to visits
- •Unwilling to be in San Antonio for a year
研究组 & 干预措施
Mobile Health App group
Mobile health app to increase rates of engagement in care in youths living with HIV
干预措施: Mobile health app (Behavioral)
Control group
Standard of care for youths living with HIV
结局指标
主要结局
Viral plasma load measurement
时间窗: 12 months
Virologic suppression is the primary goal of HIV treatment. Virologic failure is defined as a measurement over 200 copies per mL by the Department of Health and Human Services, and is the primary determinant of successful HIV control.
Completion of Feasibility Survey
时间窗: 12 months
Feasibility survey completion by participants regarding usability of the PL4Y intervention
Number of Participants With Undetectable Viral Load
时间窗: 12 months
Virologic suppression is the primary goal of HIV treatment. Virologic failure is defined as a measurement over 200 copies per mL by the Department of Health and Human Services, and is the primary determinant of successful HIV control. This outcome is categorized as: Undetectable (VL \<200 at 12 months)
Feasibility Survey Completion
时间窗: 6 and 12 month time points
Feasibility of the intervention assessed using a participant-completed survey at 6 and 12 months. Measured as number of participants that completed the survey in the arm that received the intervention only.
次要结局
未报告次要终点