Feasibility Testing of a Novel mHealth Intervention to Improve Adherence to Antiretroviral Therapy Among HIV+ Men Who Have Sex With Men (MSM) Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Suppressed viral load at 3-months
研究概览
简要总结
This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.
详细描述
Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral suppression. Yet few interventions have been developed to address adherence in this population with unique developmental/psychosocial needs. Mobile technology, which is constantly consumed by youth, has the potential to deliver interventions that provide support and feedback in real time as youth go about their daily lives.
This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention (mHealth app) targeting medication adherence among HIV+ youth. It is a three-month prospective feasibility trial to test a medication adherence mobile application consisting of two study visits: baseline and 3-month follow up.
Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for participant satisfaction with the app, demographics, and mental health and risk behaviors, as well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males (sex at birth male) age 14 to 24 years.
- •HIV-positive
- •Owns an Android smart phone
- •Within 1-month of initiating antiretroviral therapy (ART) medication, previously failed ART and about to restart an ART regimen, or currently on ART having trouble with adherence (defined as having a detectable viral load above 200 copies/ml).
- •MSM (men who have sex with men)
- •Receiving care at the Children's Hospital of Philadelphia (CHOP) Adolescent HIV clinic at the time of the study
排除标准
- •Females (sex at birth; not gender)
- •Males age 13 years or younger or 25 years and older.
- •HIV-negative or status unknown
- •Not in care at the CHOP Adolescent HIV clinic at the time of the study.
- •Does not own an Android smart phone (iPhone, Blackberry, etc. phone users)
- •Is already ART adherent (defined as having an undetectable or suppressed, <200 copies/ml, viral load) or is not on or going to be on ART during the study period.
研究组 & 干预措施
HIV medication adherence app
Youth in this arm will receive a medication adherence application to help them remember to take their HIV treatment medication (antiretroviral therapy) as a supplement to current HIV standard of care.
干预措施: HIV medication adherence app (Device)
结局指标
主要结局
Suppressed viral load at 3-months
时间窗: 3 months
Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at the 3-month follow-up study visit.
次要结局
- Self-reported medication adherence rates by participants at 3 months(3 months)
- Measure participant satisfaction of the medication adherence application at 3-months(3 months)
- Self-reported medication adherence rates by participants over 3-months within the medication adherence application(3 months)
- Medication adherence measure using prescription refill information(3 months)
- Suppressed viral load at 6-months(6 months)